RU2446750C2 - Method of treating and prevention of posthysterectomy prolapse in earlier operated women - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to operative gynecology. Vaginal access to vaginal cupula is performed. After that, vaginal cupula, stumps of cardinal and sascro-uterine ligaments are extraperetonially rigidly fixed with thread to the middle of synthetic band 1.5×50 cm. By means of measuring band distance from introitus to vaginal cupula top is measured, and obtained parameter plus 4 cm from each side is measured from the middle of synthetic band in opposite directions and marks by marker are made. Then, 2.0 cm above symphysis pubis, on median line made is 2.0 cm long skin cut, and after that, bilaterally, indenting from it 3.0-4.0 cm to each side, two analogous cuts are made. Then, synthetic band is brought through urogenital diaphragm in paravesical space with perforation of aponeurosis of external oblique abdominal muscle through lateral skin cuts on anterior abdominal wall from respective side. Vaginal cupula is pulled to earlier applied mark by ends of synthetic band. After that, both free ends of synthetic band are brought in subcutaneous adipose cellular tissue above aponeurosis and brought out through median cut, where they are fixed to each other by means of prolene thread, after which they are submerged into subcutaneous adipose cellular tissue without rigid fixation to aponeurosis.

EFFECT: method makes it possible to reduce operation trauma, eliminate formation of commissures in post-operative period, reduce frequency of infectious and hemorrhagic complications, eliminate disease recurrences, preserve vector of physiological position of vagina axis.

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Description

The invention relates to medicine, in particular to operative gynecology, and will find application in the implementation of colpofixation in previously operated women.

Genital prolapse (PG) is a common disease of modern women, one of the leading places in the structure of gynecological pathology. This disease does not apply to conditions that directly threaten the patient’s life, but due to anatomical connections, it causes functional failure of various organs and systems, leads to persistent social maladaptation, reduced quality of life and disability. In the structure of gynecological diseases, the omission and prolapse of the internal genital organs, requiring surgical treatment, is 25-28%. In recent years, there has been a "rejuvenation" and the appearance of complicated and recurring forms of this pathology (Popov A.A., 2001; Pushkar D.Yu., 2000; Radzinsky V.E., 2006).

A particular problem is post-hysterectomy prolapse. The frequency of vaginal canopy falling out after a hysterectomy reaches 43% (Buyanova S.N., 1998, T. Mascarenhas, 2003), and many researchers believe that vaginal canopy and urinary incontinence are directly related to surgical treatment. because the operation violates the anatomical relationship, leads to denervation of the bladder and pelvic diaphragm failure (Zussman L., 1981; Semm K., 1991; Pushkar D.Yu., 1990; Lyamina ES, 2004).

In reconstructive surgery of the pelvic floor, treatment methods have been developed using non-absorbable synthetic materials for the relapse-free restoration of tissue defects (GyneMesh mesh, Gynecare Prolift pelvic floor restoration system). However, the unpredictability of the reaction of the body to a foreign body can lead to the formation of chronic inflammation, which can cause a number of adverse effects, up to rejection of the implant.

These circumstances initiate the development of new approaches to the choice of surgical tactics, optimization of surgical interventions and anti-relapse technologies (Mexidol in the program for surgical correction of genital prolapse // A.G. YASCHUK, L.A.DAUTOVA RUSSIAN BULLETIN OF THE OBSTETRIAN-GYNECOLOGIST 6, 2008, p. 74-78).

Currently, specialists are working both in the modification of methods for surgical correction of post-systerectomy genital prolapse and the prevention of relapse, and in the development of new methods for the surgical treatment of genital prolapse using biogenic materials. The safety and effectiveness of their use (immediate and long-term results) were evaluated.

The use of the Alloplant biogenic material (dura mater, TMT) is described, which is highly effective in patients with OiVVPO and fascial paravaginal tissue defects. The technology for the elimination of cystourethrocele, as well as the creation and strengthening of the vaginal wall is as follows: a longitudinal flap of various sizes, depending on one form or another of the defect, is cut out from the front wall of the vagina, sometimes a longitudinal mucosal incision is made without excising the tissues of the vaginal mucosa. Then the mucous membrane is separated on both sides, a tunnel is formed between the vaginal mucosa and the pelvic fascia, where a wide plate of TMT biomaterial is placed in the horizontal plane so as to cover the fascia defect by at least 1 cm. The plate is fixed with 1-2 vicryl sutures to the underlying tissues , the vaginal mucosa is sutured with a continuous vicryl suture (RF Patent No. 2350291, 03/27/2009).

A known method of laparoscopic colpofixation (RF Patent No. 2182470, 05/20/2002), including entering the abdominal cavity through laparoscopic access, using mercilene or prolene flaps 2 × 30 cm, fixing the center of the flap to the sacro-uterine ligaments with non-absorbable suture material, holding the flap and extraperitone fixation of flaps, characterized in that when fixing the ligatures to the sacro-uterine ligaments, the anterior wall of the rectum is captured into the sutures, and tunnels are formed extraperitoneally from the external aponeurosis the wasp of the abdominal muscle to the sacro-uterine ligaments and through them free segments of the flap lead to the anterior abdominal wall, then form a tunnel over the aponeurosis of the external oblique muscle of the abdomen, through which the ligature is made of non-absorbable material, and connect both segments in a state of moderate tension, the extra part mesh cut off. The disadvantages of this method include the need to enter the abdominal cavity (laparoscopic access), the inability to perform re-neuroplasty (plasty of the pelvic floor muscles) from one access, the need for only endotracheal anesthesia.

A known method of laparoscopic colpofixation during hysterectomy (RF Patent No. 2307618, 10/10/2007), including the removal of the uterus and the formation of a vaginal dome by vaginal access, vaginopexy using laparoscopic access, with the formation of extraperitoneal channels, passing through them fixing stumps of the uterine ligaments of the elements, excretion and fixation the latter above the aponeurosis of the external oblique muscle of the abdomen, characterized in that after removal of the uterus, using vaginal access on one side, 10-15 mm away from the freedoms of the stump of each stump, the stump of the cardinal and sacro-uterine ligaments is stitched with a non-absorbable ligature with the capture of the vaginal wall, one of the ends of the ligature is cut off after tying the knot, and the other is placed in the abdominal cavity, the stump of the cardinal and sacro-uterine ligaments on the other side is similarly stitched which forms the dome of the vagina, then under the control of a laparoscope, lateral trocars are inserted into the abdominal cavity, piercing the anterior abdominal wall, retreating medially 2-4 cm from the upper anterior iliac spine with each side, then to form an extraperitoneal canal, one trocar is removed and, before reaching the peritoneum, a uterine probe-conductor with an opening at the working end (hereinafter referred to as the probe) is inserted into the formed canal, it is advanced extraperitoneally under the control of a laparoscope under the base of the stump of a round uterine ligament of the same hand, perforate the peritoneum with a probe in the stump of the sacro-uterine ligament and conduct the probe into the abdominal cavity, with the help of a manipulator inserted through the lateral trocar of the opposite side, pass through the hole f probe the free end of the ligature, fixing the stump of the ligaments on the side of the formed extraperitoneal canal and remove it with the back of the probe from the abdominal cavity, similarly remove the other end of the ligature from the opposite side, after which one of the ends of the ligatures is drawn over the aponeurosis of the external oblique muscle of the abdomen in subcutaneous fatty tissue to the site of excretion of the other end of the ligature, the ends of the ligatures tighten and bind together, completing vaginopexy. The disadvantages of this method are the need to enter the abdominal cavity (laparoscopic access), the inability to perform re-neuroplasty (plastic surgery of the pelvic floor muscles) from one access, a vaginal approach is necessary, the need for only endotracheal anesthesia, the use of standard non-absorbable suture material cannot provide the necessary long-term strength . The described fixation of ligatures allows the possibility of excessive tension of the vaginal dome on only one side.

As a prototype, the closest to the claimed method of laparoscopic colpo-fixation was chosen, which can be performed in combination with a hysterectomy performed by vaginal access (RF patent No. 2182470, 05.20.2002).

The disadvantages of the prototype method are eliminated in the claimed invention.

The objective of the invention is to develop a method of colpofixation, the implementation of which is possible in previously operated women, which allows to reduce the invasiveness of the intervention and the frequency of infectious and hemorrhagic complications by fixing the vaginal dome in the physiological position and reliable prevention of prolapse and prolapse of the internal genital organs after a previously performed hysterectomy.

The problem is solved by performing colfixation using only minimally invasive vaginal access: the dome of the vagina, the stump of the cardinal and sacro-uterine ligaments are extrapertonally rigidly fixed with a suture thread to the middle of the synthetic tape 1.5 × 50 cm, the distance (d) is measured from the introitus to the introitus the tops of the dome of the vagina and lay from the middle of the synthetic tape in opposite directions, the obtained indicator (d) is added to it by 4 cm on each side (taking into account the average thickness of the anterior abdominal wall above the bosom) and make marks with a marker, then 2.0 cm above the pubic joint, a skin incision 2.0 cm long is made in the midline, and then bilaterally, departing from it 3.0-4.0 cm in each direction, two similar section; using a conductor tool, the synthetic tape is passed through the urogenital diaphragm in the paravesical space with the aponeurosis of the external oblique muscle of the abdomen and removed through the lateral skin incisions on the anterior abdominal wall from the corresponding side beyond the edges of the mesh brought out above the skin, the vaginal dome is pulled up to the previously marked mark on the synthetic tape, using a tool-conductor, both free ends of the tape are carried out in the subcutaneous fat over the aponeurosis and displayed through the midline incision, where iksiruyut between a polypropylene thread, and then freely immersed in the subcutaneous fatty tissue without rigid fixation to the aponeurosis, the integrity of the bladder estimated cystoscopy, vaginal mucosa recovers vicryl sutures.

A new technical result obtained by the implementation of the proposed method is that the development of persistent pain after the operation is eliminated due to the mobile fixation of the vagina in the form of a “swing”, which allows the body to independently “carry out” the symmetry of the tension of the flap of the synthetic tape. The use of synthetic material serves as a reliable prevention of prolapse and prolapse of the internal genital organs after a previously performed hysterectomy, as it allows you to fix the dome of the vagina in the physiological position individually for each patient.

A detailed description of the method and examples of its clinical implementation

Under spinal anesthesia, after processing the surgical field, the stump of the cervix or vagina is fixed in the mirrors with bullet forceps. Make a circular incision of the vaginal mucosa. With closed scissors inserted under the mucosa, the bladder is separated from the vagina and fascia covering the mucosa, moving the scissors to the upper corner of the wound. (The upper corner of the wound is 3 cm from the external opening of the urethra). A midline cut through the vaginal mucosa. In a partially acute, partially blunt way, the vaginal mucosa is additionally mobilized bilaterally from the bladder. On the back wall, the mucous membrane is separated to the remains of the cardinal and sacro-uterine ligaments. In the presence of the cervix, clamps are gradually applied, cardinal, sacro-uterine ligaments and vascular bundles are crossed and doped. The stumps of the above ligaments using prolene suture (Prolene Polypropylene w8526 2-0 90 cm on the needle MN-1 mm 1 \ 2s round Bodied) rigidly fix the middle of the synthetic tape (using an endoprosthesis mesh polypropylene-polyvinylidene fluoride 1.5 × 50 cm company "Linteks" St. Petersburg). In the absence of a cervical stump, the synthetic tape is fixed to the stumps of the cardinal and sacro-uterine ligaments. 2.0 cm above the pubic joint in the midline, a skin incision is made 1.5-2.0 cm long, then bilaterally, departing from it 3.0-4.0 cm in each direction, two similar incisions are made. A probe conductor is inserted into the lumen of the Foley catheter No. 18, and the bladder is catheterized. A rigid catheter allows you to divert the bladder and urethra away from the path of the guide tool. Using a sterile measuring tape, measure the distance (d) from the introitus to the top of the vaginal canopy, then from the middle of the synthetic tape, the obtained indicator (d) +4 cm is laid in opposite directions (taking into account the average thickness of the anterior abdominal wall above the fold), and make the corresponding marks on the tape permanently marker. Using a conductor tool, under the control of a finger inserted into the vagina, extraperitoneally, the synthetic tape is passed paravesically through the urogenital diaphragm and perforating the aponeurosis of the external oblique muscle of the abdomen, removed through a side incision above the skin from the corresponding side. Similarly, the procedure is performed on the other hand. When the conductors reach the skin incisions, cystoscopy is performed to monitor the integrity of the bladder. Over the edges of the tape brought out above the skin, the dome of the vagina is pulled up to the previously applied mark on the synthetic tape. Using a conductor tool, both ends of the tape are carried out under the skin over the aponeurosis and removed through a midline incision, the excess tape is cut off, the ends are sutured together with a suture thread, and then immersed in subcutaneous fatty tissue without a “hard” fixation to the aponeurosis. The skin is sutured with separate sutures according to Donati. The integrity of the vaginal mucosa is restored with individual No. 2-0 vicryl sutures.

A diamond-shaped flap is cut from the posterior wall of the vagina, the mucous membrane is separated from the perineum, then a vertical incision is made of the mucosa of the posterior wall of the vagina. In an acute way, the vaginal mucosa exfoliates to the right and left, excess mucosa is cut off with scissors. Legs mm are distinguished. levatores ani, grab and stitch the edges of the levators with No. 0 vikril seams, take the ends of the threads to the clamp and pull them down, depending on the size of the wound, lay the second and then the third seam on the levators. The vaginal mucosa is sutured with separate Vicryl sutures No. 2-0, the threads superimposed on the levators are fixed. The perineal skin is sutured with separate vicryl stitches according to Donati.

The performance of the proposed method is confirmed by the following clinical examples.

Clinical example 1.

Patient R-ova, 59 years old, went to the clinic with complaints of constant pulling pains in the lower abdomen, discomfort in the perineum, difficulty urinating. These complaints are noted over the past 3 years. From the anamnesis, a 48-year-old patient underwent a supravaginal amputation of the uterus without appendages for a multinodular form of uterine fibroids complicated by pain, bleeding from the lower middle laparotomy incision.

With vaginal examination: the external genitalia are developed correctly. According to the standardized classification of genital prolapse POP-Q, the degree of omission corresponds to stage IV. When conducting Valsalva tests and “coughing” urine losses were not detected. The stump of the cervix is cylindrical, without cicatricial deformity. Appendages on both sides are not palpable, their areas are painless. Clinical and laboratory examination without pathology.

When conducting a comprehensive urodynamic study of the lower urinary tract, neurogenic bladder dysfunction was not detected. Ultrasound examination without features.

Diagnosis: failure of the muscles of the pelvic floor, complete prolapse of the stump of the cervix.

Operation: vaginal extirpation of the cervical stump, backward fixation of the vaginal dome with synthetic tape according to the present method. Colporaphia, perineolevatoroplasty.

The total duration of the operation was 65 minutes. Total intraoperative blood loss of 150 ml.

Intraoperatively, antibiotic prophylaxis was carried out with drugs from the group of cephalosparins, which lasted for 48 hours. To prevent thromboembolic complications, Clexane 0.2 mg was used subcutaneously for 24 hours for 4-5 days. In the postoperative period, complications were not observed, the sutures healed by primary intention. The Foley urinary catheter was removed on the 2nd day. Discharged from the hospital on the 6th day after the operation. Examined 1 month after surgery. No complaints. During the “cough” and Valsalva tests, there is no loss of urine. Urination 6-8 times a day, free painless. During a gynecological examination, the dome of the vagina is located high in the pelvis. No tape erosion. Dynamic observation was carried out after 4 and 12 months. In a sick stump, the vagina remains high in the pelvis. Ultrasound examination without features, pain is absent.

Clinical example 2.

Patient L-th, 54 years old, went to the clinic complaining of a foreign body feeling in the vaginal area, difficulty urinating, and impossibility of sexual intercourse for 2 years. At the age of 49, the patient underwent laparotomy according to Pfannenstiel, hysterectomy with appendages for uterine fibroids complicated by bleeding.

With vaginal examination: the external genitalia are developed correctly. The dome of the vagina completely extends beyond the genital gap. According to the standardized classification of genital prolapse POP-Q, the degree of omission corresponds to stage IV. When conducting a cough test and Valsalva test, urine leakage was not detected. Appendages are not palpable, their areas are painless.

The patient underwent a comprehensive clinical examination, including clinical, laboratory, instrumental, and ultrasound studies; no contraindications to surgery were revealed.

When conducting a comprehensive urodynamic study of the lower urinary tract, neurogenic bladder dysfunction of the bladder was not detected.

Diagnosis: complete loss of the vaginal canopy, pelvic floor muscle failure.

The operation was performed: postadilon fixation of the vaginal stump with synthetic tape according to the present method, kolpoperineolevatoroplasty.

The total duration of the operation was 60 minutes. Intraoperative blood loss of 100 ml.

The antibiotic prophylaxis of generation III cephalosporins was carried out intraoperatively, which lasted for 48 hours. To prevent thromboembolic complications, low molecular weight heparins were used subcutaneously "Clexan" 0.2 mg per day for 4-5 days. In the postoperative period, complications were not observed, the sutures healed by primary intention. The Foley urinary catheter was removed on the 2nd day. The patient was discharged from the hospital on the 7th day after the operation. Examined 1 month after surgery. No complaints. When conducting a “cough” test and Valsalva test, there is no loss of urine. Urination 5-7 times a day, free painless. During a gynecological examination, the dome of the vagina is located high in the pelvis. No tape erosion. Dynamic observation was carried out after 4 and 12 months. In the patient, the vaginal stump remains high in the pelvis. Ultrasound examination without features, pain is absent.

The advantages of the proposed method over the known ones are to increase the viability and physiology of vaginopexy while reducing the invasiveness of the intervention by eliminating the weakening, “sagging” of the elements fixing the dome of the vagina by reducing the length and width of the extraperitoneal canals, provided that adequate fixation of the internal organs to achieve reliable correction and prevention omissions in hysterectomy.

Since 2005, we have operated on 52 patients with prolapse and prolapse of the dome of the vagina, cervix, who had previously undergone total or subtotal hysterectomy in gynecological hospitals in the city and region.

Examination of patients included a standard clinical and laboratory examination, gynecological examination, ultrasound of the pelvic organs using vaginal and abdominal approaches, a comprehensive urodynamic study. The hospital stay was from 5 to 7 days. The Foley catheter was removed on the 2nd day of the postoperative period. Long-term results were studied in the observation period of up to 5 years.

In one patient, 2 months after the operation, the appearance of a clinic of neurogenic bladder dysfunction was noted, which required the appointment of additional drug therapy for 3 months. The total percentage of complications was 3.8%.

When analyzing the long-term results of surgical treatment, patient complaints were studied, subjective assessment of the effectiveness of surgical treatment, transvaginal and transabdominal ultrasound of the pelvis, and vaginal examination with functional tests were taken into account. The results of surgical treatment were evaluated as positive, satisfactory and unsatisfactory.

Positive results were assessed in patients who did not show complaints and did not have signs of genital prolapse during examination. Satisfactory results were found in patients who noted a significant improvement in overall health after treatment, but had moderate prolapse of the vaginal walls, mild sexual dysfunction, and a violation of urination. The results of the development of PHEG in the form of prolapse of the vaginal canopy, the appearance of symptoms of stress urinary incontinence and sexual disorders were considered unsatisfactory. In our study, 2 unsatisfactory results of the treatment according to the claimed method were revealed, this is the appearance of a clinic for neurogenic bladder dysfunction, which required the appointment of additional drug therapy for 3 months. Evaluation of the effectiveness of the proposed method of surgical treatment was carried out in the period from 6 months to 4.5 years. Based on the indicators of quality of life according to the Nottingham Health Profile scale, modified for gynecological patients, all women noted an improvement in the quality of life in such parameters as “physical activity”, “emotional reactions”, and “pain”. During a clinical examination with a re-evaluation of the degree of prolapse by the POP-Q test, 0-1 stage was established in all patients. Ultrasound examination with visualization of the mesh implant made it possible to evaluate its support function for the dome of the vagina. In all cases, there was no such complication as erosion of the vaginal mucosa, dyspareunic phenomena were not noted in more than one case. Thus, the positive results of surgical treatment - improving the quality of life and the absence of relapse of the disease over a long period of observation - allow us to evaluate the proposed method as highly effective.

The total percentage of complications was 3.8%. All results obtained were compared with published data.

Statistical processing of the material was carried out using the software package Statistica v.5.5 and Genepop v.1.2.

The method we offer has the following advantages:

1. Surgery is possible in patients who have been operated on earlier, with the presence of an adhesion process in the abdominal cavity.

2. The minimum invasiveness of the operation reduces intraoperative blood loss, reduces the time of the operation, eliminates the formation of adhesions in the postoperative period, significantly reduces the frequency of infectious complications in the early and late postoperative periods.

3. After the operation, the vector of the physiological position of the axis of the vagina is saved, which prevents sexual disorders after surgery.

4. "Soft" fixation of the flaps of the synthetic tape to the aponeurosis using a nadaponeurotic bridge between the right and left fragments of the flap (the "swing" effect) prevents the asymmetry of the tension of the flaps, and the large distance between them avoids the eruption of the fixing ligatures and relapse prolapse.

5. The absence of mucosal tension minimizes the risk of dystrophic complications, and a good cosmetic effect is maintained.

6. The ability to perform surgery under spinal or epidural anesthesia.

The inventive method of treatment of post hysterectomy prolapse in previously operated women was tested on sufficient clinical material and can be recommended for use in surgical hospitals.

Claims (1)

A method for the treatment and prevention of post hysterectomy prolapse in previously operated women, including colpofixation using polypropylene flaps, fixation of the center of the flap to the sacro-uterine and cardinal ligaments with non-absorbable suture material, flap extraperitoneal and fixation of the flaps, characterized by access to the vagina extraperitoneally, with a prolene thread, the middle of the synthetic tape 1.5 × 50 cm is firmly fixed, the distance is measured with a measuring tape from the introitus to the top of the dome of the vagina and lay from the middle of the synthetic tape in opposite directions, the obtained indicator is added to it by 4 cm on each side and marks are made with a permanent marker, then 2.0 cm above the pubic joint along the midline perform a skin incision length 1.5-2.0 cm, then bilaterally, departing from the median line 3.0-4.0 cm in each direction, perform two similar cuts, using a guide tool, the synthetic tape is passed through the urogenital diaphragm paravesically, perf Orienting the aponeurosis of the external oblique muscle of the abdomen, it is led out through the side incisions on the anterior abdominal wall from the corresponding side, beyond the edges of the tape brought out above the fold, the dome of the vagina is pulled up to the mark previously made on the synthetic tape, using the guide tool, both ends of the tape are carried out under the skin and excreted through the midline incision, excess tape is cut off, the ends are sutured together with a suture thread, and then immersed in subcutaneous fatty tissue without a “hard” fixation to aponeurosis, after which the integrity of the mucous membrane was wetted looking for repair with individual vicryl stitches.