RU2748678C2 - Laparoscopic bilateral hysterocervicocolposuspension using titanium mesh implants in patients with apical prolapse - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to operative gynecology. A laparoscopic approach enters the abdominal cavity, performs short incisions and inserts three trocars at typical points: the lower edge of the umbilicus and on both sides of the inguinal-iliac region. With laparoscopic means and under visual control, the pelvic organs are revised and passages from the aponeurosis are formed extraperitoneally on both sides in the direction of the uterus, cervix or vagina. Two ribbon-shaped mesh implants, 20 cm long and 1 cm wide, made of polyfilament or monofilament suture made of titanell alloy - VT-1.00 or VT6, are inserted into the formed lateral incisions (1 cm) on the right and left retroperitoneally with the help of conductors. For patients with a preserved uterus, the ends of the implant tapes are placed under the round ligaments, up to the point where they leave the uterus on both sides, the ends of the tapes are localized and fixed to the lateral wall of the uterus at the base of the round ligaments with non-absorbable ligatures made of Etibond type material. For patients after hysterectomy, the ends of the implant tapes are placed in the area of ​​the cut round ligaments, the ends of the tapes are localized and fixed to the cervical stump or to the vaginal dome and to each other also with Etibond ligatures so that the ends of the tapes are fixed to the cervical stump or to the vaginal dome formed a single support apparatus. The physiological position of the uterus, cervical stump or vaginal dome is restored under bilateral - laparoscopic and transvaginal - visual control, pulling on the peripheral ends of the implant bands, reaching a symmetrical position relative to the terminal line. Then, bending the ends of the implant bands and / or pressing them to the aponeurosis, the excess bands are cut off. The incisions are sutured, surgery is completed.

EFFECT: method makes it possible to reduce the complexity of the surgical intervention and the time required for the operation, to reduce its trauma and blood loss, to improve tissue healing, accordingly, the duration of the postoperative rehabilitation period of the patient is reduced, the possibility of complications and relapses is excluded.

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Description

The invention relates to medicine and can be used in operative gynecology for the surgical treatment of women with apical prolapse, including with a preserved uterus or after subtotal or total hysterectomy.

In accordance with the Encyclopedic Dictionary of Medical Terms (see electronic resource: / I / http://www.tcmedservice.ru/others/voc.pdf) the term "hysterocervicocolposuspension" in operative gynecology means "related to the support, suspension of the uterus, cervix and / or vagina. "

Currently, in operative gynecology for the treatment and prevention of prolapse of the pelvic organs of women, the use of mesh implants is widely practiced. (See, for example, / 1 / Guidelines No. 3 of the Moscow Department of Health, Pelvic organ prolapse, / Pushkar D. Yu. Moscow, 2016.58 p. In that chile, 121 Shkarupa D.D. Reconstruction of the vaginal dome and apical sling in the surgical treatment of post-hysterectomy prolapse of the pelvic organs. J. obstetrics and female diseases. - 2017. T. 66, No. 1, pp. 46-55).

All mesh implants are divided into 2 types according to the installation principle: installed using trocars (with perforation of the skin and soft tissues) and installed without the help of trocars. Trocar techniques are performed using special kits - systems made of steel guide needles and a monofilament macroporous mesh installed with their help, implanted on the pelvic floor without tension. They have proven to be highly effective.

At the same time, when using synthetic mesh implants, a number of disadvantages appear, which are expressed in the form of postoperative complications and occur due to insufficient biocompatibility of these synthetic materials with body tissues (see / 1, 21, and also / 3 / Zhukovsky V.A. for hernioplpstika .-- SPb .: Esculap, 2011.104 s).

As a rule, the inflammatory reaction (first exudative, then cellular) begins on the third day, and from the 10th day the activity of fibroblasts begins to prevail. The ratio between the number of inflammatory cells and fibroblasts characterizes the mechanical properties of the material and its biocompatibility. The strength of a synthetic prosthesis increases over time, for example, for polypropylene and polytetrafluoroethylene, it doubles between 3 and 12 weeks.

According to a multicenter study (/ 4 / Manodoro S, Reato C, Cola A, Palmieri S, Frigerio M. Prolapse mesh complication: large stone on vaginal mesh extruded in the bladder. Eur J Obstet Gynecol Reprod Biol. 2019 Feb 20. pii: S0301-2115 (19) 30079-X. Doi: 10.1016 / j.ejogrb.2019.02.012.), The total number of MESH-associated and general surgical complications in the correction of genital prolapse is 22.4%.

The presented data show that due to the possible development of mesh-associated complications, recurrence of diseases and other disadvantages of synthetic implants, the problem of their biocompatibility is still unresolved. There is a search for the possibility of using other materials in reconstructive surgery, including in operative gynecology for genital prolapse.

In recent years, our country has developed and actively introduced into clinical practice mesh implants of various sizes and shapes, made of monofilament or polyfilament titanium threads (including VT1-00 alloy) with a titanium content from 80% to 99% or more (see / 5 / The use of titanium-containing mesh and suture materials. Analytical review, collection of articles of the Central Clinical Hospital of the Russian Academy of Sciences. M., / AA Kazantsev et al. 2015 97 p., / 6 / RF patent for utility model No. 121735, dated 29.11.2011, Mesh implant for reconstructive surgery).

An example of the use of titanium alloy in surgical gynecology is a method of surgical correction of prolapse of the uterus and the anterior wall of the vagina (cystocele) by vaginal access (/ 7 / RF patent for invention No. 2688433 dated December 11, 2017), including the reconstruction of the pelvic floor by installing a mesh implant made from "titanium silk", while performing anterior colporrhaphy with a transverse approach, separating the walls of the vagina to the internal obturator muscle and iliac spine on both sides, isolating sacrospinous ligaments on both sides, using an implant made of titanium "silk", the anterior central part of which is fixed to the vaginal wall in the area of the border with the bladder neck with two sutures at 11 and 13 o'clock, a similar manipulation is carried out with the lower edge of the mesh, which is fixed to the cervix with two sutures at 5 and 7 o'clock, using the Serapro tool for suturing the sacrospinal ligament, bilateral suturing is performed sacrospinal ligament in the area its middle third, followed by fixation to the lower angle of the implant extended to 3-4 cm and gradual tension to the physiological position of the anterior vaginal wall; the anterior angles of the implant, after they are pulled up to 3-4 cm, are sutured, followed by passing the suture through the anterior transobturator passage, the suture is stretched until the mesh angle penetrates the internal obturator muscle to the physiological location of the implant made of titanium "silk", the remaining defect of the anterior vaginal wall is sutured. In this case, a titanium silk mesh implant is placed using reusable instruments: an instrument for suturing the sacrospinal ligament from the Serapro system and an anterior transobturator trocar from the OPUR system, and a mesh implant for reconstruction of the anterior and apical sections has a ready-made shape of 11 × 6 cm.

The disadvantages of the analog are. The analogue solution cannot be used to solve the problem posed in the inventive method because, with anterior colporrhaphy with a transverse approach, the vaginal walls are separated to the internal obturator muscle and the iliac spine on both sides, the implant from the fixation points is attached to the sacrospinal ligaments and to other parts of the rear compartment.

Also, the analogue method is distinguished by a complex technique of execution and a high duration (vaginal, transverse access, anterior transobturator passage, separating the vaginal walls to the internal obturator muscle and iliac spine on both sides, the Serapro instrument for suturing the sacrospinal ligament, etc.), which requires a highly qualified surgeon and can lead to inaccuracies during the operation and increased blood loss.

In addition, the titanium silk implant must be straightened due to its increased flexibility, also during the operation - the complexity of the multi-point suturing of the implant, in comparison with the solution of the problem according to the claimed invention.

A group of analogs quite close to the claimed invention are methods of treating various forms of apical prolapse of the pelvic organs, both with a preserved uterus and after its removal, using mesh (sling) technologies with abdominal access. Analog methods, in some cases, are usually supplemented with auxiliary stages (plication of the sacro-uterine ligaments, obliteration of the anterior-uterine or Douglas space, etc.). Such methods are described in the following analogs:

/ 8 / RF patent for invention №2129839, from 1999. Authors: Ishchenko AI and others. "Method of laparoscopic treatment of prolapse of the uterus and vaginal walls, complicated by stress urinary incontinence." The method includes fixing the uterus by the sacro-uterine ligaments, it is characterized by the fact that, under the control of laparoscopy, an extraperitoneal canal is formed from the pubis (pubic region) to the sacro-uterine ligaments on each side, is passed through the canals along a synthetic graft, one of the ends of each graft is brought out into the abdominal cavity in the region of the sacro-uterine ligaments and fixed to the latter, retreating 5 - 7 mm from the body of the uterus, after which the Retziev space is opened and 0.5 - 0.6 ml of medical glue is injected on both sides of the bladder neck, then pressed the anterior wall of the vagina from the side of its lumen to the posterior surface of the bosom until they are glued, then the sacro-uterine ligaments, the anterior surface of the rectum and the posterior wall of the vagina are sutured together under visual control from the abdominal cavity, the other ends of the grafts are pulled until the uterus takes a physiological position and stitched together, perform colpoperineorrhaphy.

Disadvantages of analog. Another problem is solved, in comparison with the claimed method, and other means. Treat stress urinary incontinence, while strengthening other elements of the supporting apparatus and compartments. Using glue, the anterior wall of the vagina and the neck of the bladder are attached to the posterior surface of the bosom, the sacro-uterine ligaments, the anterior surface of the rectum and the posterior wall of the vagina are sutured together.

A synthetic mesh material such as prolene or mersilene is used as the implant. At the same time, it is known that when using these materials, implants containing them have a diffuse exchange with surrounding tissues, and to one degree or another undergo erosion, cellular or non-cellular biodegradation and other destructive processes (/ 3 / Zhukovsky V.A., / 9 / Krasnopolsky VI, Popov AA et al. Complications of extraperitoneal colpopexy with mesh prostheses: results of a multicenter study // Russian Bulletin of Obstetrician-Gynecologist T. 10, No. 6: 2010. - pp. 53-57). In addition, the complexity of the operation performed requires high qualifications of the surgeon.

/ 10 / RF patent for invention №2465851. A method of suspending a prolapsed cervical or vaginal stump after radical operations on the pelvic organs. The operation is performed in two stages: The first stage, gluttony according to the standard technique, revision of the pelvic organs. Further, if this is a cervical stump, then the dropped stump from the abdominal cavity is stitched with a ligature-holder after pulling the cervical stump to the wound, while on its posterior surface above the attachment of the sacro-uterine ligaments, a transverse incision is made up to 1 cm deep. (or propylene) mesh 2 × 15 cm in size is immersed in the incision in the cervix so that two ends of equal size are obtained. The mesh is fixed to the cervix with several prolene or nylon sutures. If this is a vaginal stump, then at the vaginal stump the peritoneum covering it is dissected and separated, and a 3 × 10 cm prolene mesh is immersed in the formed pocket along its posterior wall. Fixing sutures are applied without penetration into the organ cavity. In addition to the vaginal stump, the stumps of the uterine ligaments are sutured. After that, the prolene mesh is dissected longitudinally with scissors. The incision ends approximately 2 cm from the vaginal stump. The second stage is the creation of canals in the anterior abdominal wall, as is done in the Doleri-Giilliam operation (https://medspecial.ru/wiki/Giilliam-Dolerioperation/), and through them the ends of the mesh are brought out to the aponeurosis. The ends of the mesh are sewn together above the aponeurosis and fixed to it with separate nylon sutures. To prevent infringement of the intestinal loops, the vesicouterine space is closed by the imposition of 2-3 sutures. The abdominal wall is tightly sutured in layers.

The disadvantages of the analog are. The solution to another problem, in comparison with the claimed method, and other means: the attachment of the implant is carried out to the back wall of the cervix or vagina. The analogous method can be applied only to patients after radical operations on the pelvic organs.

A synthetic material is used as an implant: a prolene (or propylene) mesh. In this case, the material of the implant is more or less exposed to erosion, cellular or non-cellular biodegradation and other destructive processes, changes its size and other biophysical parameters (/ 3 /, / 9 /), which in some cases leads to MESH-associated complications and relapse of the disease.

Also, due to the fact that in the method for attaching a single flap to the tissues: “... its 2 × 15 cm segment is immersed in an incision on the cervix so that two equal ends are obtained or, if it is a vaginal stump, then at the vaginal stump the peritoneum covering it is dissected and separated, and the mesh 3 × 10 cm in size is immersed in the formed pocket along its posterior wall and after that a segment of the specified prolene mesh is dissected longitudinally with scissors, not reaching 2 cm to the vaginal stump, and its ends are brought out to the aponeurosis, similar to the stage Doleri-Giilliam's operations ... ", then there is a complexity and multi-stage operation, which requires a high qualification of the surgeon, is poorly tolerated by patients and can lead to errors in the operation and to additional blood loss.

The next analogue / 12 / - RF patent for invention No. 2182470 dated 11.11.1998: Method of laparoscopic colpofixation. It can be used with a preserved uterus and after hysterectomy, and includes entry into the abdominal cavity through a laparoscope, use of mersilene or prolene flaps 2 × 30 cm, fixation of the center of the flap to the sacro-uterine ligaments with non-absorbable suture material, extraperitoneal flap placement and flap fixation ... The method is characterized by the fact that when fixing the ligatures to the sacro-uterine ligaments, the anterior rectal wall is captured in the sutures. Further, under the control of vision, according to the position of the lateral trocars, an endoscopic clamp extraperitoneally form tunnels from the aponeurosis of the external oblique abdominal muscle to the sacro-uterine ligaments, through which free flap segments are brought out to the anterior abdominal wall. Tunnels are formed in the avascular area adjacent to the parietal peritoneum tissue without opening the latter. Next, a tunnel is formed above the aponeurosis of the external oblique muscle of the abdomen, connecting both segments of the flap, through which a ligature of non-absorbable material is passed. The segments are fixed to each other using a ligature in a state of moderate tension, the excess part of the mesh is cut off. In the variant after hysterectomy, the flap is fixed to the stumps of the sacro-uterine ligaments, then it is passed into the abdominal cavity (on the aponeurosis), the dome of the vagina is formed, after which laparoscopy with vaginopexy is performed.

The analog has the following disadvantages. Another problem is solved, in comparison with the claimed method, while other elements of the supporting apparatus and compartments are strengthened: when fixing the ligatures to the sacro-uterine ligaments, the front wall of the rectum is captured in the sutures in order to obliterate the post-uterine space. A single implant flap is passed into the abdominal cavity from the left side extraperitoneally to the left and right sacro-uterine ligaments, through which free flap segments are brought out to the anterior abdominal wall, then a tunnel is formed above the aponeurosis of the external oblique abdominal muscle, connecting both flap segments through which the ligature is passed made of non-absorbable material. In this case, only the middle part of the flap is fixed in one place - either to the sacro-uterine ligaments (if the uterus is intact), or to the stumps of the sacro-uterine ligaments (after hysterectomy). As a result, a rear sling is formed.

A synthetic mesh material is used as an implant: prolene or mersilene. In this case, the material of the implant is more or less exposed to erosion, cellular or non-cellular biodegradation and other destructive processes, changes its size and other biophysical parameters (/ 3 /, / 9 /), which in some cases leads to MESH-associated complications and relapse of the disease.

The method of laparoscopic hysteropexy or vaginopexy (/ 11 / RF patent for invention №2304937, dated 20.12.2005), as the closest analogue is adopted as a prototype. Typical laparoscopy is performed (with two lateral trocars at a typical location 5 cm above the symphysis and 8 cm in the lateral midline). After revision of the abdominal organs through the left lateral puncture under the control of a laparoscope, from the outer edge of the external oblique abdominal muscle, an extraperitoneal laparoscopic clamp is used to make a tunnel between the leaves of the left wide uterine ligament. Then, extraperitoneally, the tunnel is continued over the left and right sacro-uterine ligaments and between the leaves of the wide right uterine ligament - to the outer edge of the right external oblique abdominal muscle. A mersilene or prolene flap 2 × 35 cm is passed through the tunnel made with a laparoscopic clamp, the ends of which extend onto the aponeurosis of the spruce and right sides of the outer edge of the external oblique muscles of the anterior abdominal wall. The excess ends of the flap are cut off. The ends of the flap are left free. The flap is fixed only in one place - in the region of the sacro-uterine ligaments (with the uterus intact) and in the region of the posterior wall of the vagina (in the absence of the uterus) with 2-3 interrupted sutures using non-absorbable suture material. The so-called extraperitoneal rear sling is formed. Carry out "mobile" fixation of the vagina with the aim of symmetrical tension of the flap, which is to prevent the development of persistent pain syndrome after surgery. The method can be used with preserved uterus and after hysterectomy.

The prototype has the following disadvantages. Another problem is solved, in comparison with the claimed method, while other elements of the supporting apparatus and compartments are strengthened: the only flap of the implant is carried out into the abdominal cavity from the left side between the leaves of the left wide uterine ligament, extraperitoneally above the left and right sacro-uterine ligaments and, further, between the leaves of the right wide uterine ligament on the right side, it is brought back to the aponeurosis (this last stage significantly complicates the process, which increases the risk of tissue damage), leaving the ends of the flap on the aponeurosis free. In addition, in this case, the middle part of the flap is fixed only in one place - in the region of the sacro-uterine ligaments (with the uterus intact) or in the region of the posterior wall of the vagina (in the absence of the uterus), forming the so-called "posterior sling".

A synthetic mesh material such as prolene or mersilene is used as the implant. In this case, the material of the implant is more or less exposed to erosion, cellular or non-cellular biodegradation and other destructive processes, changes its size and other biophysical parameters (/ 3 /, 19 /), which in some cases leads to MESH-associated complications and relapse diseases.

The objective of the invention is to improve the technique of surgical treatment of apical prolapse in patients, both with a preserved uterus and after hysterectomy, using a minimally invasive technique using an implant made of a new material in the form of a mesh tape made of titanium threads (Titanella) to reduce the risk of postoperative complications and relapses possible when using implants made of synthetic materials.

The solution to this problem is achieved by implementing a new method of laparoscopic bilateral hysterocervicocolus suspension with the installation of mesh implants in patients with apical prolapse of the preserved uterus, or cervical stump or vaginal dome after total or subtotal hysterectomy, including the following stages:

enter the abdominal cavity by laparoscopic approach using trocars at typical points,

laparoscopic means conduct a revision of the pelvic organs,

under the control of vision, according to the position of the lateral trocars through punctures on both sides, channels are formed extraperitoneally to the patient's pelvic organs,

and through them extraperitoneally, flaps of a mesh ribbon-like implant are passed between the leaves of the broad ligament of the uterus in the direction of the pelvic organs and the patient's ligaments, to which the implant is fixed using non-absorbable suture material,

free segments of the implant are brought out to the anterior abdominal wall,

with the help of these segments, the physiological position of the uterus or the operated genitals is restored, ensuring the symmetry of their placement,

the protruding ends of the flaps above the aponeurosis are left free, the excess part of the implant is cut off,

characterized in that, under aseptic conditions, the introduction of trocars is performed at three points of the abdominal cavity: the lower edge of the navel and on both sides of the inguinal-iliac region,

at the level of entry of the round ligaments into the inguinal canal, on one side, the skin is dissected to a length of 1 cm and through the incision in a blunt way through all layers of the anterior abdominal wall, extraperitoneally, using a metal guide, fixed to the guide, a tape of one of the two mesh implants to the preserved or operated tissues is carried out (ligaments) of the uterus or vagina, in order to fix the end of the tape to them,

moreover, the tape of each of these implants is made of titanium threads and has dimensions of 20 × 1 cm, with a pointed end,

after that, the conductor is released and taken out backwards,

the manipulation is repeated on the other side with the second implant,

In this case, for patients with a preserved uterus, the inserted ends of the implant tapes under laparoscopic control are placed retroperitoneally under the round ligaments, up to the point where the ligaments leave the body of the uterus on both sides, on the left and right, the ends of the tapes are localized and fixed to the lateral walls of the uterus at the base of the round ligaments with non-absorbable ligatures,

and for patients after subtotal or total hysterectomy, the inserted ends of the implant tapes under laparoscopic control are placed retroperitoneally in the area of the cut round ligaments on both sides, left and right, the ends of the tapes are localized and fixed to the cervical stump or to the dome of the vagina and to each other in the apical part, non-absorbable ligatures, stitching the tapes together so that they form a single fixing device,

the physiological position of the preserved uterus is restored under bilateral: laparoscopic and transvaginal visual control, by pulling the peripheral ends of these implant bands until the bases of the sacro-uterine ligaments reach 2 cm below the level of the terminal line (linea terminalis) of the pelvis and symmetrical position,

and the physiological position of the operated stump of the cervix or the dome of the vagina is restored in the same way, until the fixation points of the implants reach the level and symmetrical position relative to the specified terminal line,

free segments of the implant are cut off above the skin level by 1.5 - 2 cm, and the protruding part of the mesh is bent over the aponeurosis (the properties of the titanium threads of the implant are selected by its manufacturer so that they allow the ends of the tape to be bent and maintain the resulting shape),

the incisions are sutured, the plastic is completed.

In particular, they use implants made of a polyfilament thread of titanium alloy "titanell", such as VT-1.00 or VT6.

In particular, the ends of the implants are fixed to the uterus, to the stump of the cervix or the dome of the vagina with 2-4 sutures, in place, depending on the size of the organs.

In particular, when the implants are fixed to the cervical stump or the vaginal dome, they are additionally fixed along the midline of the vaginal dome or the cervical stump.

In particular, an Etibond thread is used as a fixing suture material.

The work was carried out at the V.F. Snegirev - the clinical base of the Department of Obstetrics and Gynecology No. 1 of the Faculty of Medicine of the First Moscow State Medical University named after M.V. THEM. Sechenov of the Ministry of Health of Russia.

We observed 15 patients of the pre- and post-menopausal period with prolapse of the preserved uterus or in women after hysterectomy, with prolapse of the cervical stump or vaginal dome. They underwent a comprehensive examination, surgical treatment and observation in the early and delayed postoperative periods. The patients' age ranged from 40 to 65 years. The study group was formed by the method of continuous thematic sampling.

The criteria for inclusion in the work were: categories of patients: with a preserved uterus or after total or subtotal hysterectomy, prolapse: "C" -prolapse (apical, central) degree: 1, 2, 3 - uterus, cervical stump or vaginal dome (for example, classification of prolapse see / 13 / V.V.Bakhaev et al ...), the presence of written informed consent of the patient, female, over the age of 18 years, with genital prolapse to participate in the study, satisfactory results of clinical and laboratory studies, informed consent to surgery and anesthesia.

The exclusion criteria were: severe extraginetal pathology that does not allow surgery, including laparoscopic access, polyvalent allergy and inflammatory diseases of the pelvic organs, lack of consent to surgery.

The technical result is achieved due to the following advantages.

For the surgical treatment of apical prolapse in this method, the most suitable ribbon-like mesh implants made of titanium alloy are used, their advantages are confirmed by the Methodological Recommendations ... / 1 / and the principles of implantation set forth therein.

The most gentle laparoscopic approach to the abdominal cavity is used through short (about 1 cm) incisions in the skin using three trocars under continuous laparoscopic visual control of the operation, which ensures the minimum invasiveness of the procedure.

At the same time, the number of stages of the operation is minimized (complexity is reduced). Namely, in the course of the intervention, the conductors with mesh flaps are provided in one direction from the entrance to the abdominal cavity laterally through the avascular region to the places of implant attachment in the anterior region to the uterus, cervical stump or to the dome of the vagina. At the same time, the time for performing the operation is significantly reduced (duration - no more than 55 minutes). It is also important that the trauma of exposure and blood loss are reduced, which facilitates the patient's condition in the postoperative period.

The used two mesh implant flaps, which are used for the reconstruction of the apical section to help the weakened elements of the supporting apparatus of the genital organs, have a simple ribbon-like shape; during the patient's active life, only tensile forces are applied to them, which increases the reliability of the structure. Also, the specified implant has a finished shape, and the side and end edges of the bands are smoothed due to a special mesh weaving technology (see Fig. 1 and 2).

It is known that the implant material - titanium alloy titanella - does not undergo cellular or non-cellular biodegradation and other destructive processes, its dimensions remain constant, which ensures almost complete absence of MESH-associated complications and disease relapses. Studies have shown (see / 5 /) the advantages of a titanium mesh endoprosthesis in comparison with synthetic ones, for example, made of polypropylene. These include: ultimate biological inertness; 100% integration with connective tissue due to the peculiarities of weaving and knitting in 3D; the formation of type I collagen on titanium and, as a result, the formation of mature connective tissue and a thin, dense scar, while type III collagen is deposited on polypropylene, which leads to the development of immature connective tissue and a coarser scar; lack of initiation of aseptic (serous) inflammation, in contrast to polypropylene analogs; extremely low wick, since titanium does not promote the adhesion of microorganisms and is not a nutrient medium for them. In addition, unlike titanium, polypropylene is susceptible to destruction under the influence of chemotherapy. The absence of structural changes during long-term follow-up, while polypropylene implants are partially destroyed after 5-6 years, which leads to deformation of the prosthesis, foreign body sensation, dyspareunia and pelvic pain syndrome.

The combination of high rates of bioinertness and special structural and mechanical properties of a titanium alloy mesh (/ 5 /, / 14 / OOO NPF "Temp", Surgical titanium suture material "Titanell" (sterile), RU RZN 2013/756, 6.16. Suture materials and related products) ensures the formation of a thin and uniform scar in the implantation zone, the implant material is highly resistant to infection, strength, surgical adaptability and has a suitable porous structure, which is necessary for more efficient germination of mature collagen.

The use of treated threads made of titanium of the "Titanell" type - unalloyed titanium VT-1.00 or VT6 - in the mesh of the proposed implant made it possible to optimize its flexibility and elasticity so as to best match the patient's genital support apparatus being replaced by its own elements. Usually the diameter of the threads of the "Titanell" mesh corresponds to the 4/0 diameter according to the USP suture classification (which corresponds to the diameter range of 0.150 - 0.199 mm), but can be promptly increased or decreased in accordance with the requirements for the implant, since it is produced on a domestic technological base ... This reduces the cost of the implant.

As a result, the method allows to reduce the complexity of the surgical intervention and the time required for the operation, reduces its trauma and blood loss, improves tissue healing. Accordingly, the duration of the postoperative rehabilitation period of the patient is reduced, the possibility of complications and relapses is practically excluded.

Implementation of the invention, examples.

FIG. 1 shows an implant in the form of a mesh, woven from multifilament threads, the material of which is Titanell (tape, 1 cm wide, 20 cm long, pointed end, the diameter of the threads corresponds to the diameter of 4/0 according to the USP classification).

FIG. 2 shows the middle portion of the tape of the implant shown in FIG. one.

Clinical case No. 1. Patient M, 42 years old, was in the gynecological department of the Clinical Hospital No. 2 from 01/09/2020 to 01/17/2020.

Diagnosis at admission: "C" prolapse of the uterus 2 tbsp. Complains of discomfort, a feeling of a foreign body in the vagina.

Anamnesis: Blood transfusion history: not burdened. Gynecological history: Menstruation from 13 years, moderate, painless. Last menstrual period: on time. Pregnancies: 8. Births: 3: 2010, 2013, 2018 - timely spontaneous. Induced abortion: 0. Spontaneous miscarriages: 4 - undeveloped pregnancy. Gynecological diseases: 2001 - laparoscopy, resection of the right ovary. Allergies and intolerances: denies. Past diseases: childhood infections, ARVI.

Medical history: Since 2013, she has been worried about vaginal discomfort. Strengthening of complaints - since 2018. When contacting the Clinic of Obstetrics and Gynecology, it was diagnosed: "C" uterine prolapse 2 tbsp. According to ultrasound data: the body of the uterus is 55 × 40 × 55 mm, the contours are even. M-echo: 3 mm, endometrial structure: 3 mm. Right ovary: 30 × 15 mm, maximum follicle: 6 mm. Left ovary: 30 × 14 mm, smooth contours, maximum follicle: 5 mm.

Examination, clinical examination from 25.12.2019: Blood group: B (III), Rh positive, RW, HBS-Ag, HCV, HIV: negative. Complete blood count, biochemical blood test, hormonal studies, urine analysis: indicators are within normal limits. Scrapings of the cervix and cervical canal: epithelial cells without atypia. Coagulogram: - within normal limits. Microscopy of urogenital smears: within normal limits. Chest X-ray from 12/25/2019: a variant of the norm. ECG: Sinus rhythm, vertical position of the EOS: a variant of the norm. Examination by a therapist dated 12/27/2019: there are no contraindications to surgery.

On January 10, 2020, an operation was performed according to the method claimed in the invention (Laparoscopy, bilateral hysterocervicocolposus suspension using titanium mesh implants). Under aseptic conditions, a pneumoperitoneum CO2 (4.5 l) is typically imposed, in the incisions on the skin: 1 cm at the points of the abdominal cavity (the lower edge of the navel and on both sides of the inguinal-iliac region), a laparoscope and two manipulators are inserted. Laparoscopic means are used to revise the pelvic organs. The body of the uterus is pink, not enlarged. Right and left fallopian tubes without visible pathological changes. The right ovary is 2.0 x 2.5 x 2.0 cm. The left ovary is 2.5 x 3.0 x 2.5 cm, the surface is smooth, no visual changes are observed. The peritoneum of the small pelvis is smooth, shiny, there is no effusion, no visible pathological changes in the abdominal organs were found. Surgical diagnosis: "C" - prolapse 2 tbsp.

Further, under the control of vision, according to the position of the lateral trocars at the level of the entry of the round ligaments into the inguinal canal, the skin was dissected to a length of 1 cm on one side and through the aponeurosis of the external oblique muscle of the abdomen, an extraperitoneally blunt way was carried out using a metal conductor, a tape of one of the two mesh implants, and the tape of each implant is made of titanium threads (Titanell alloy) and has dimensions of 20 × 1 cm, with a pointed end. Under laparoscopic control, the tape is passed retroperitoneally under the round ligament between the leaves of the broad ligament of the uterus, and placed to the base of the round ligament, at the place where it leaves the body of the uterus on the indicated side, after which the conductor is released and taken out backwards.

The manipulation is repeated in the same way with the second implant band on the other side.

On the left and right, the ends of the tapes are localized and fixed to the lateral wall of the uterus at the base of the round ligaments of the uterus with non-absorbable ligatures (Etibond). By sipping on the ends of titanium tapes, under laparoscopic and transvaginal visual control, the physiological position of the uterus is restored until the bases of the sacro-uterine ligaments reach 2 cm below the level of the terminal line of the pelvis (linea terminalis), and they reach a symmetrical position. The free segments of the implants were cut off 1.5 cm above the skin level, and their protruding part was fixed in the incisions by bending over the aponeurosis to the contralateral side. Peritonization of the implant was performed with a continuous suture due to the leaves of the previously separated parietal peritoneum. The tools have been removed. Sutures are applied to the skin, aseptic stickers. Blood loss 10 ml. Urine through an indwelling catheter 150 ml, light.

The postoperative period was uneventful. Antibacterial, analgesic, anticoagulant, infusion and anti-inflammatory therapy, physiotherapy were carried out. Healing of seams by primary intention.

Clinical analyzes from 01/14/2020: Clinical and laboratory indicators (biochemical blood test, urine analysis, coagulogram, general blood count) - within normal limits._Ultrasound from 01/14/2020: The right and left kidneys are not enlarged, the PCS of both kidneys not expanded. No calculi were found. The uterus measures 52 × 35 × 43 mm. There is no liquid in the small basin. Conclusion: Condition after surgery.

The patient was discharged home on the 8th day after the operation. The condition is satisfactory. Recommendations: 1. Compliance with the medical and protective regime, diet and diet, limiting physical activity during the month. 2. Consultation of a therapist at the place of residence. 3. Appearance for a control examination after 1 month. 4. Suppositories: Indomethacin 100 mg in the rectum - 10 days. 5. Suppositories: Dexpanthenol + chlorhexidine, 1 suppository x 2 r / day, vaginally - 7 days.

Control examination 02/18/2020 Gynecological status: the external genitalia are developed correctly. The genital slit is closed. The cervix is cylindrical, not eroded, located high, and normal. The body of the uterus is not enlarged, dense, painless. The appendages on both sides are not defined, their area is painless. The vaults are free, painless. Discharge from the genital tract is light, scanty. Subsequent control examinations were carried out after 3 and (6 - plan) months.

During the observation of the postoperative period in this patient, the results of clinical and laboratory studies were within normal limits, the condition was satisfactory, complications and relapse were not observed.

Clinical case No. 2. Patient R., 60 years old, was in the gynecological department of the Clinical Hospital No. 2 from 02.12.2019 to 12.12.2019.

On admission, she complains of discomfort, a feeling of a foreign body in the vagina. Clinical diagnosis: Complete prolapse of the vaginal dome. In 2005 - vaginal extirpation of the uterus with left appendages. Concomitant diagnosis: CHD; Hypertensive heart disease II degree, chronic gastritis, remission.

Anamnesis: Blood transfusion history: not burdened. Allergies and intolerances: denies. Gynecological history: Menstruation from: 14 years, on time - after 28 days. In 2005 - laparotomy, extirpation of the uterus with left appendages. Childbirth: 1978.1982 - urgent spontaneous childbirth (without complications). Induced abortion: 3. Gynecological diseases: Erosion of the cervix - DEC in 1980. In 2005 - vaginal extirpation of the uterus with left appendages. Past illnesses influenza, acute respiratory infections. CHD, Hypertensive disease II degree, chronic gastritis, remission.

Medical history: According to the patient, the above pains have been bothering her for 2 years. I went to the Clinic of Obstetrics and Gynecology of the First Moscow State Medical University. THEM. Sechenov.

Examination, clinical examination of the patient - (in the period: from 10/04/19 to 11/19/19). Blood group: A (I). The Rh factor is positive. RW, HCV, Hbs-Ag, HIV: negative. Clinical blood test, biochemical blood test, general urine analysis: within normal limits. Smear from V and C: indicators within normal limits. FVD: indicators within normal limits. ECG from 7/11/19: Sinus rhythm, vertical position of the EOS. A variant of the norm. Consultation of a therapist dated 10/29/19: Hypertensive disease of the II degree, there are no contraindications to surgical treatment. Chest X-ray from 09.09.19: no pathological changes. Colonoscopy from 09/30/19: colon polyp, removed by biopsy. Indirect signs of adhesions in the abdominal cavity. EGDS from 10/28/19: superficial gastritis. Indirect signs of diseases of the pancreato-biliary system. Consultation of a cardiologist from 11/19/19: VPS. Doppler ultrasound of the veins of the lower extremities from 11/19/19: Superficial and deep veins of the lower extremities are passable at all levels. Moderate wellbore and tributary expansion in the BPV and MPV system. According to ultrasound (31.10.2019): Right ovary 20 × 12 mm. The left ovary was surgically removed (2005). High defect of the pubocervical fascia, classic cystocele is not located. An extended colposcopy was performed: Complete prolapse of the vaginal dome was diagnosed. Surgical treatment is recommended.

On 04.12.2019, an operation was performed according to the method of the invention: Laparoscopy, lateral colpopexy using titanium mesh implants, oophorectomy on the right.

Under aseptic conditions, pneumoperitoneum CO2 (4.5 l) is imposed, three incisions are made on the skin: 1 cm in typical points of the abdominal cavity (the lower edge of the navel and on both sides of the inguinal-iliac region), three trocars are inserted: one laparoscope and two manipulators ... Laparoscopic means are used to revise the pelvic organs. According to the results of laparoscopy: the vaginal dome is not visually changed, is mobile, closed by the plica-vesica uterinae peritoneum, the uterus and left appendages are absent (previously removed), the right ovary: 1.5 × 1.0 × 1.5 cm.The pelvic peritoneum is smooth , shiny, no effusion, no other visible pathological changes in the abdominal organs were found. Surgical diagnosis: Complete prolapse of the vaginal dome. After bipolar coagulation, the funnel-pelvic ligament is transected on the right. The macroscopic specimen is removed in an endoevacuator through the left trocar opening. The vesicouterine fold is opened.

Further, at the level of the entry of the round ligaments into the inguinal canal, the skin is dissected to a length of 1 cm and, on one side, through the aponeurosis of the external oblique abdominal muscle, and then extraperitoneally, it is carried out using a metal conductor, a tape of one of two mesh implants 20 × 1 cm in size is fixed to it, with with a pointed end made of titanium threads (Titanell alloy) in the area of the severed round ligament and brought out to the dome of the vagina, fixed on the trackball, after which the conductor is released and taken out backward. The manipulation of the second implant band is repeated on the other side. The inserted ends of the implant tapes under laparoscopic control are fixed to the vaginal dome for 3 cm and between each other with 3 non-absorbable ligatures (Etibond), additionally with the same ligatures fixation is performed along the midline of the vaginal dome. By pulling on the peripheral ends of titanium tapes, under laparoscopic and transvaginal visual control, the physiological position of the vaginal dome is restored until the point of implant fixation reaches the plane of the terminal line (linea terminalis) of the pelvis, thus providing symmetrical suspension of the vaginal dome. Free segments of the implants are cut off above the skin level by 1.5 cm, and their protruding part is fixed in the incisions by bending over the aponeurosis to the contralateral side. Peritonization of the implant is performed with a continuous suture due to the leaves of the previously separated parietal peritoneum. The tools are removed. Sutures are applied to the skin, aseptic stickers.

The postoperative period was uneventful. Healing of sutures on the perineum by primary intention. Antibacterial, analgesic, anticoagulant therapy was carried out (ceftriaxone 1.0 i / m × 2 r-day - 7 days; metrogil 100.0 i / v cap. × 2 r / day; ketonal 2.0 i / m × 2 r / day; clexane 0.4 s.c. 1 r / day - 10 days; Sol.Glucosae 5% -400.0 + Sol.Ac.Ascorbinici 5% -5.0 i.v. cap .; Ringer's solution 500.0 v / in carp), physiotherapy. Healing of seams by primary intention.

Clinical analyzes. Biochemical blood test from 09.12.2019: within normal limits. Complete blood count: within normal limits. Urine test: within normal limits. Coagulogram: Fibrinogen: 4.22 g / l; % prothrombin according to Quick: 89%; MHO: 1.07; APTT: 1.02 Ratio. Anti-erythrocyte antibody screening: not detected. Ultrasound from 09.12.2019: the dome of the vagina is normal, there are no hematomas, the urethra is stable, the sphincter of the urethra is normal. Residual urine - no more than 30 ml, there is no free fluid in the small pelvis. Conclusion: Condition after surgery.

The patient was discharged home on the 9th day. The condition is satisfactory. Discharge from the genital tract is light, scanty. Recommendations: 1. Compliance with the medical and protective regime, diet and diet, limiting physical activity during the month. 2. Consultation and supervision of a therapist at the place of residence. 3. Appearance for a control examination after 1 month. 4. Suppositories: Indomethacin 100 mg in the rectum - 10 days. 5. Suppositories: Dexpanthenol + chlorhexidine, 1 suppository x 2 r / day. vaginally - 7 days.

Control examinations were carried out after 1, 3 and 6 months.

During the observation period in the specified postoperative period in this patient, the results of clinical and laboratory studies were within the normal range, the condition is satisfactory, no complications or relapse were observed. Gynecological status: the external genital organs are developed correctly. The genital slit is closed. When straining, there is no prolapse of the vaginal walls.

During the observation period of all patients in the study group, their condition was satisfactory, complications and relapse were not observed, no complaints were presented. Gynecological status: the external genital organs are developed correctly. The genital slit is closed. When straining, there is no prolapse of the vaginal walls.

Sources of

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Claims (24)

1. The method of laparoscopic bilateral hysterocervicocolus suspension with the installation of mesh implants in patients with apical prolapse of the uterus, cervical stump or vaginal dome, including the steps: enter the abdominal cavity by laparoscopic approach using trocars at typical points, laparoscopic means conduct a revision of the pelvic organs, under the control of vision, according to the position of the lateral trocars through punctures on both sides, channels are formed extraperitoneally to the pelvic organs of the patient and through them extraperitoneally, flaps of a mesh ribbon-like implant are passed between the leaves of the broad ligament of the uterus in the direction of the pelvic organs and the patient's ligaments, to which the implant is fixed using non-absorbable suture material, free segments of the implant are brought out to the anterior abdominal wall, with the help of these segments, the physiological position of the uterus or the operated genitals is restored, ensuring the symmetry of their placement, the protruding ends of the flaps over the aponeurosis are left free, the excess part of the implant is cut off, characterized in that, under aseptic conditions, the introduction of trocars is performed at three points of the abdominal cavity: the lower edge of the navel and on both sides of the inguinal-iliac region, at the level of entry of the round ligaments into the inguinal canal, 1 cm long skin is dissected on one side and through the incision in a blunt way through all layers of the anterior abdominal wall, extraperitoneally, using a metal guide, a tape of one of the two mesh implants fixed to the guide wire is drawn to the preserved or operated tissues-ligaments of the uterus or the vagina in order to fix the end of the tape to them, moreover, the tape of each of these implants is made of titanium threads and has dimensions of 20 × 1 cm with a pointed end, after that, the conductor is released and taken out backwards, the manipulation is repeated on the other side with the second implant, In this case, for patients with a preserved uterus, the inserted ends of the implant tapes under laparoscopic control are placed retroperitoneally under the round ligaments, up to the point where the ligaments leave the body of the uterus on both sides, on the left and right, the ends of the tapes are localized and fixed to the lateral walls of the uterus at the base of the round ligaments with non-absorbable ligatures, and for patients after subtotal or total hysterectomy, the inserted ends of the implant tapes under laparoscopic control are placed retroperitoneally in the area of the cut round ligaments on both sides, left and right, the ends of the tapes are localized and fixed to the cervical stump or to the dome of the vagina and to each other in the apical part, non-absorbable ligatures, stitching the tapes together so that they form a single fixing device, the physiological position of the preserved uterus is restored under bilateral - laparoscopic and transvaginal - visual control by pulling the peripheral ends of these implant bands until the bases of the sacro-uterine ligaments reach 2 cm below the level of the terminal line, linea terminalis, pelvis and symmetrical position, and the physiological position of the operated cervical stump or vaginal dome is restored in the same way until the fixation points of the implants reach a symmetrical position relative to the specified terminal line, free segments of the implant are cut off above the skin level by 1.5-2 cm, and the protruding part of the mesh is folded over the aponeurosis, the incisions are sutured, the plastic is completed. 2. The method according to claim 1, characterized in that implants are used made of a polyfilament thread of titanium alloy "titanell" of the VT-1.00 or VT6 type. 3. The method according to claim 1, characterized in that the ends of the implants are fixed to the uterus, to the stump of the cervix or the dome of the vagina with 2-4 sutures in place, depending on the size of the organs. 4. The method according to claim 1, characterized in that when the implants are fixed to the cervical stump or the vaginal dome, they are additionally fixed along the midline of the vaginal dome or the cervical stump. 5. The method according to claim 1, characterized in that a thread of the "Etibond" type is used as a suture material.

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