RU2753473C1 - Device for implementing a method for treating chronic paraproctitis complicated by the formation of transsphincter or extrasphincter fistulas of the rectum - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to coloproctology, and can be used to optimize the treatment of patients with chronic paraproctitis complicated by the formation of an intrasphincter, transsphincter or extrasphincter fistula of the rectum, in the non-hospital setting. The device for the treatment of chronic paraproctitis complicated by the formation of transsphincter or extrasphincter fistulas of the rectum consists of a handle and a working part. The handle of the device is made of a hard, inflexible metal in the form of a hexagon with a rough surface that prevents sliding when working with the tool. The working part of the device is made with the possibility of modeling its shape by bending in accordance with the topographic and anatomical course of the fistula canal. The working part is made of flexible metal in the form of a round guide rod with a diameter of 2.0 mm, at the end of which there is an extension in the form of an oblong loop with a size of 3.0×0.3 mm with a hole in the center with a diameter of 2.0 mm for threading a latex or vicryl seton 2.0. The distal part of the loop is completed with an oblong elastic olive, due to which the guide rod is freely moved along with the seton along the fistula canal.

EFFECT: provides a reduction in pain syndrome by optimizing the passage of seton through the fistula canal with minimizing tissue injury and reducing the number of necessary puffs, the possibility of performing manipulation in the non-hospital setting using local anesthesia, reducing the healing time of the wound by effectively draining the purulent cavity and creating favorable conditions for wound regeneration after ligature eruption and excision of the fistula, reducing the frequency of relapses.

1 cl, 1 dwg

Description

The proposed invention relates to medicine, namely to coloproctology, and can be used to optimize the treatment of patients with chronic paraproctitis complicated by the formation of intrasphincteric, transsphincteric or extrasphincteric rectal fistula, on an outpatient basis.

Previously, we presented a "Method for the treatment of chronic paraproctitis, complicated by the formation of transsphincteric or extrasphincteric rectal fistulas", for which a Russian patent No. 2697286 was received. Currently, we have developed a special original device for the implementation of this method.

The problem of diagnosis and treatment of chronic paraproctitis, complicated by the formation of rectal fistulas, remains important and extremely relevant in modern kelvproctology. Fistulas of the rectum account for 15-45% of patients in the structure of colorectal pathology (Aminev A.M., 1973; Cirocco W.C., 1991).

In the Russian Federation, according to the National Clinical Guidelines (Shelygin Yu.A. et al., 2013), they adhere to the clinical and anatomical classification, reflecting the location of the fistulous tract in relation to the fibers of the rectal sphincter. In accordance with this, intrasphincteric, transsphincteric and extrasphincteric fistulas of the rectum are distinguished (Fedorova V.D. et al., 1984; Vorobiev G.I., 2006).

To date, the only radical way to treat rectal fistulas is surgical. In the surgical treatment of intrasphincteric fistulas of the rectum, the following operations are used: dissection of the fistula into the lumen of the rectum; excision of a fistula into the rectal lumen (Gabriel's operation); excision of the fistula with opening and drainage of purulent cavities of pararectal tissue. In the surgical treatment of transsphincteric fistulas, three types of excision of the fistula into the lumen of the rectum are used: with suturing the bottom of the wound; with partial suturing of the bottom of the wound, opening and drainage of the purulent cavity; with the opening and drainage of the purulent cavity.

The greatest number of operations has been proposed for the treatment of patients with extrasphincteric rectal fistulas. This is due to the high and complex location of the fistulous tract, which bends around the outside of the sphincter fibers of the anus, the frequent combination of this type of fistula with purulent cavities in the pararectal cellular spaces and the developed cicatricial process along the fistula in the wall of the rectum at its inner opening. In the treatment of extrasphincteric rectal fistulas (high-level fistulas), four types of fistula excision are most often used: 1) with suturing its stump in the perineal wound and with posterior dosed sphincterotomy - the method of A.N. Redhead, used in two versions; 2) with dissection of the fistula into the lumen of the rectum and suturing of the sphincter fibers; 3) with plastic displacement of the mucous membrane of the anal canal; 4) with ligature.

Patients with extrasphincteric fistulas of the III degree of complexity are recommended to perform excision of the fistula with plastic movement of the mucous membrane of the anal canal and excision of the fistula with ligature. With extrasphincteric fistulas of the IV degree of complexity, as a rule, only the ligature method of operation is applicable, since an extensive cicatricial process in the anal canal and along the fistula in the presence of an active purulent process in the adrectal tissue does not allow any other operation to be performed. (V.D. Fedorov, Yu.V. Dultsev, 1984; add more recent authors).

At the same time, all of the above traditional methods of surgical treatment of transsphincteric and extrasphincteric rectal fistulas, which are currently used, are quite complex and traumatic, accompanied by a significant number of complications and relapses after surgery, which predetermines long-term rehabilitation of patients. At the same time, these surgical interventions, due to their high degree of trauma, are applicable only in a hospital setting.

Despite the advances made in the diagnosis and treatment of chronic

paraproctitis complicated by the formation of rectal fistulas, the improvement of surgical intervention technologies, including the use of minimally invasive surgical techniques, as well as the constant expansion of the possibilities of drug provision, the number of relapses and complications in this pathology has remained stably high over the past decades. So, after surgical treatment of transsphincteric and extrasphincteric rectal fistulas, relapses of the disease are observed in 15-30% of patients, and anal sphincter insufficiency in 4.9-33% of patients (Yu.V. Dultsev and K.N. Salamov, 1981; In D. Fedorov and Yu.V. Dultsev, 1984; VL Rivkin et al., 1994; V.A.Ilyin et al., 2005; F. Perez et al., 2006). Therefore, the problem of surgical treatment of transsphincteric and extrasphincteric fistulas of the rectum still remains relevant, which determines the need to search for new methods of surgical treatment of this pathology.

Thus, the high trauma of the currently used methods of surgical treatment of rectal fistulas, especially transsphincteric and extrasphincteric fistulas, leads to long-term postoperative rehabilitation of this category of patients, as well as a significant number of complications and relapses after surgery. All this dictates the need to develop new low-traumatic sphincter-preserving methods of treating patients with this pathology, applicable on an outpatient basis.

Studies conducted on the patent and scientific medical literature have revealed a significant number of titles of protection that protect all kinds of treatment methods for chronic paraproctitis complicated by the formation of rectal fistula.

The known method of plastic surgery, proposed by T.V. Abuladze. The method consists in the fact that in case of a pronounced cicatricial process after excision and cutting off of the fistula from the perineal side, its stump is sutured with a perlon and a polymer film is glued to it in the form of a patch up to 5-6 mm in size, the perineal wound is sutured with chrome-plated catgut to the skin. Separate silk sutures are applied to the skin. On the refreshed surface of the inner hole of the fistula, MK-14 glue is applied and a patch made of autofascia or a synthetic film reinforced with lavsan is glued. The patch is additionally sutured along the perimeter to the wall of the anal canal.

Moreover, with complex fistulas, when the cicatricial process affects not only the outer part of the fistulous tract, but also captures its inner opening, T.V. Abuladze proposed an original modification of the above method. In this case, after the treatment of the internal opening of the fistula and cryptectomy, the same patch is glued to its bottom. In this case, the implant is immersed deep into the anal canal, and the mucous membrane above it is sutured [Abuladze T.V. Plastic surgery for rectal fistulas. - Surgery. - 1992. - No. 2, p. 70-65].

The disadvantages of this method are:

1. Inability to control adequate fixation of the patch with biological glue, as well as the need for additional hemming of the patch with threads with pronounced wick properties.

2. Compression of tissues in the area of the internal opening, which in conditions of ischemia and secondary infection leads to suppuration and relapse of the disease.

3. When using the method for complex fistulas, a residual cavity is formed, which increases the risk of developing purulent complications (infiltrates, abscesses and recurrence of fistulas).

4. There is a risk of suture eruption and implant migration with the development of cicatricial deformity of the intestine, which predetermines the failure of the plastic stage of the operation.

5. Application of this technique using autofascia or synthetic polymers does not provide for revascularization of the plastic zone.

A known method of treating rectal fistulas using fibrin glue, which, upon contact with the environment, forms a "clot" that promotes tissue connection (Swinscoe M.T., Ventakasubramaniam A.K., Javne DG Fibrin glue for fistula-in-ano: Pp .: 3 RU 2579629 C1 51015202530354045 the evidence reviewed. // Techniques in coloyroctology. - 2005. - Vol. 9 (2), - p. 89-94). In this case, the fistulous tract is pretreated with a Volkman spoon, and then fibrin glue is introduced into the fistulous canal, which seals it. This technique allows you to seal and isolate the fistulous canal from the lumen of the rectum, which contributes to the elimination of the fistula.

Features similar to the proposed method is the possibility of eliminating the fistulous tract with the formation of a perineal wound of the minimum size, which allows you to maintain the function of holding the anal sphincter and accelerate the healing process of the wound channel.

The disadvantages of this method are:

1. A high percentage of recurrence of the disease, which may be due to insufficiently reliable treatment of the fistulous tract (incomplete removal of the epithelial lining of the fistulous tract and tissue detritus);

2. Rejection of the adhesive composition due to the development of inflammatory edema and exudative process in the fistulous canal after the intervention.

Known "A METHOD FOR SURGICAL TREATMENT OF ACUTE AND CHRONIC PARAPROCTITIS WITH A HIGH CRESCENT AND EXTRA SPINTERAL LOCATION OF FISTULA OR PURULENT PROCESS"

According to this method, the mucocutaneous-submucosal layer of the distal rectum is mobilized with the intersection of the fistulous canal. From the side of the wound, the fistulous opening is sutured. The affected crypt is excised. The long part of the mobilized flap is displaced laterally to the left or right. Cover the previously sutured fistulous opening. The skin edges of the displaced flap are sutured. The outer part of the fistulous tract is excised. The method allows to prevent the recurrence of the disease. (see Russian patent 2186528, A61B 17/00; publ. 08/10/2002.) This method has the following disadvantages.

1. This operation is not feasible in the presence of an active inflammatory process in pararectal tissue due to the high probability of inflammatory complications of the plastic stage.

2. There is a high probability of perforation of the mucocutaneous-submucosal layer of the distal rectum with the intersection of the fistulous canal in cases when the fistula is combined with a purulent cavity in the perrectal tissue, and especially if these cavities are located close to the rectal wall above the anal canal.

3. The implementation of this method does not provide for any revascularization of soft tissues in the plastic zone.

4. Necrosis of the mucous-muscular flap, eruption of sutures when performing this method inevitably lead to a recurrence of the fistula.

5. Operation and adequate closure of the internal opening of the fistula by this method is not feasible with cicatricial changes covering more than a semicircle of the rectum.

As a prototype of the present invention, the method of excision of the fistula of the rectum with the ligature and, accordingly, the device for its implementation was chosen as the closest in terms of the totality of features (Yu.V. Dultsev, K.I. Salamev, Paroproctitis. - M., 1981, p. 162), consisting in excision of the fistula by gradually crossing the bridge of the tissues separating the fistula from the anal canal with a ligature.

The method is as follows. The fistulous passage is stained with a solution of methylene blue and a bordering incision is isolated in the form of a strand to a purulent cavity, which has a communication with the lumen of the rectum. The purulent cavity in the pararectal tissue is scraped out with a Volkmann spoon and treated with a 1% alcohol solution of iodine. A rectal speculum is inserted into the rectum. A curved clamp with a silk ligature is inserted from the side of the wound through the stump of the fistulous tract or through the opened cavity. In some cases, a silk ligature is carried out from the intestinal lumen, through the internal opening of the fistula. The ligature should be placed as close as possible to the sagittal suture of the perineum. To do this, it is often necessary to extend the incision of the lower edge of the wound. This incision must necessarily reach the muscle ring of the rectal sphincter.

On the wall of the anal canal, the internal opening of the fistula and perianal skin is excised together with a narrow tape of the mucous membrane. A thick silk ligature is placed in this bed and tightened tonically, until the underlying tissue bridge is completely encircled, which ensures uniform compression of the sphincter muscle fibers, which then gradually grow together behind the ligature. In this case, the thread squeezes a small in thickness (no more than 1-1.5 cm) tissue site, consisting of the intestinal wall and rectal sphincter fibers. The upper distal part of the wound is sutured tightly, and the proximal part is tamponed with tapes with Vishnevsky's ointment. By the 11-13th day after the operation, the wound is filled with granulations and significantly narrowed. The muscle bridge of the tissue, clamped by a silk ligature, is crossed by this time, if it has not erupted with a ligature, which is periodically tightened. That is, it is necessary to strive to ensure that the silk thread all the time tightly wraps around the underlying tissue.

This method allows you to remove the fistulous passage from the pararectal tissues without simultaneously damaging the muscle structures of the anal sphincter with a ligature passing from the perineal wound through the internal fistulous opening, covering the involved portions of the anal sphincter in the aide of the ring. As the perineal wound heals, the ligature is gradually tightened, which gradually crosses the captured sphincter fibers and the fistulous course - as the tightened ligature advances, the sphincter fibers previously cut by the thread heal with scar formation without a pronounced dehiscence of the muscle edges, which makes it possible to eliminate the fistula and reduce the risk of developing anal incontinence.

The disadvantages of this method are as follows:

1. Simultaneous intersection of a large portion of the fibers of the anal sphincter with a ligature with complete intersection of the muscle ring is accompanied by the formation of a rough deforming scar, which in the suit of patients leads to the development of insufficiency of the anal sphincter.

2. Requires repeated tightening of the ligature. With this method, in order to completely cross the tissues captured by the ligature, it is required to tighten the thread on average from 5 to 7 times, which is accompanied by pain and the need for repeated local anesthesia;

3. A thick silk ligature, which is in the wound channel for a long time, absorbs the inflammatory exudate well and, having pronounced wick properties, promotes the spread of infection deep into the wound space.

4. In addition, the use of this method in all cases is associated with significant technical difficulties arising when carrying out the ligature through a narrow and convoluted fistulous canal using a conventional surgical clamp. Since the implementation of this clamp does not allow bending it in such a way that its shape clearly corresponds to the topographic and anatomical course of the fistulous canal.

5. Long stay of the patient in the hospital. Considering the need for repeated tightening of the ligature, for a slow phased transection of the sphincter muscle and elimination of the fistula, the total time of postoperative treatment and wound healing increases to 1.5-2 months.

At the same time, with extrasphincteric fistulas and high transsphincteric fistulas with pronounced cicatricial and purulent-infiltrative changes in tissues, only the ligature method of operation is still applicable. The elimination of the internal opening of the fistula occurs due to the eruption of the tissue bridge of the sphincter with a ligature with the migration of the internal opening of the fistula in the caudal direction. Behind the moving ligature, the slit wound of the anal canal wall and anal pulp is filled with granulation tissue with the formation of a connective tissue scar. Thus, due to prolonged dissection of the intestinal wall, the ends of the intersected sphincter have time to be fixed in the postoperative wound performed by granulation, which makes it possible to avoid their diastasis with the development of anal incontinence.

When applying the ligature method of treating rectal fistulas, various types of seton are used. According to modern concepts, a seton is a piece of foreign material that is passed through subcutaneous tissue or a cyst in order to provide drainage or controlled tissue transection. As a seton in the treatment of rectal fistulas, nylon or silk thread is traditionally used. Currently, with the ligature method of treating rectal fistulas, rubber (latex) setons or thick vicryl threads are also used (Karpukhina O.Yu., Sakulina K.A., Application of a rubber seton in the treatment of anorectal fistulas. Kazan. 2018, p. 326) ...

The advantages of a rubber seton and a thick monolithic vicryl ligature over nylon or silk thread are due to a number of physical properties of these materials. First of all, the dissection of the muscle fibers of the sphincter, due to the elasticity of rubber or vicryl, becomes more effective due to a larger compression reserve than that of a rigid nylon or silk thread, which reduces the number of puffs. In addition, the high surface wettability of the rubber or vicryl seton ensures good drainage, and the physical properties of the material, which does not absorb liquid, do not develop the wick effect with the spread of infection deep into the wound space.

At the same time, the passage of a rubber (latex) or vicryl seton through a narrow and branched fistulous canal in complex extrasphincteric fistulas and high transphincteric fistulas using standard surgical instruments (for example, a curved clamp) causes significant technical difficulties. In this case, the use of a rigid and rigid metal instrument as a conductor of a seton through a narrow and tortuous fistulous canal can be quite traumatic manipulation, accompanied by the creation of a "false path", damage to the anal sphincter fibers, the rectal wall, prevailing vessels and nerves, and can also lead to the spread of infection deep into the pararectal wound space. At the same time, in the literature available to us, there is no description of a device specially designed for carrying out and installing a rubber (latex) or vicryl seton in the treatment of patients with extrasphincteric and transsphincteric fistulas of the rectum.

The aim of the present invention is to create an original device for establishing a latex or vicryl seton using the ligature method in the treatment of high transsphincteric and complex extrasphincteric anorectal fistulas. This will help reduce the trauma of surgery and, accordingly, reduce the postoperative pain syndrome when using the ligature method in the surgical treatment of complex anorectal fistulas in patients with chronic paraproctitis, which leads to a reduction in the length of stay of patients in the hospital, and, accordingly, contributes to an increase in the effectiveness of treatment.

The objective of the invention is to develop a new effective device used in the treatment of chronic paraproctitis complicated by the formation of an anorectal fistula. The disadvantages of the prototype are eliminated in the claimed invention.

The inventive method involves the use of a special tool for carrying out and installing a seton in the fistulous passage of the rectum, which helps to reduce the number of required puffs and minimize the associated pain, does not require anesthesia and can be performed on an outpatient basis, provides effective drainage of the postoperative wound with a decrease in the risk of preserving cavities and leaks along the fistula, reduces the likelihood of developing characteristic complications associated with damage to the sphincter (anal incontinence or postoperative stricture) and shortens the length of hospital stay.

The task is solved by the fact that before the operation (excision of the fistulous tract), in order to ensure effective drainage of purulent cavities in the perrectal tissue and the elimination of the purulent-inflammatory process along the anorectal fistulous canal, a latex or vicryl seton was installed in all patients. When passing the seton through the fistulous course, we used a special instrument developed by us. In most cases, the main indication for the installation of a seton in the fistula was the involvement of a part of the anal sphincter fibers in the cicatricial-inflammatory process along the fistula. In the presence of two or more external fistulous openings, we tried to install a seton in each of the fistulous passages as close as possible to the internal opening of the fistula. In the presence of complexly branched fistulous passages, the seton was carried out along the main canal of the fistula, also as close as possible to its internal opening. The installation of the seton was considered as a preparatory stage for the subsequent implementation of a radical surgical intervention. At the second stage of treatment, after the relief of pronounced signs of a purulent-inflammatory process, a radical surgical intervention was carried out in the hospital aimed at eliminating the fistula.

The technical result of the claimed invention is: the use of a tool developed by us, which helps to reduce pain by optimizing the conduction of the seton through the fistulous canal, minimizing tissue injury and reducing the number of required puffs, the ability to perform manipulations on an outpatient basis using local anesthesia, reducing the time of wound healing by effective drainage of the purulent cavity and the creation of favorable conditions for wound regeneration after the eruption of the ligature and excision of the fistula, reducing the frequency of relapses

The technical result is achieved in that the device for implementing the method of treating chronic paraproctitis, complicated by the formation of transsphincteric or extrasphincteric fistulas of the rectum, is characterized by the fact that it consists of a handle and a working part, while the handle of the device is made of a hard inflexible metal in the form of a hexagon with a rough surface , which prevents slipping when working with the instrument, and the working part of the device is made with the possibility of modeling its shape by bending in accordance with the topographic and anatomical course of the fistulous canal, while the working part is made of flexible and thin metal in the form of a round guide rod with a diameter of 2.0 mm, at the end of which there is an extension in the form of a thin oblong loop measuring 3.0 × 0.3 mm with a hole in the center with a diameter of 2.0 mm for threading a seton 2.0; the distal part of the loop is covered with an elongated elastic olive, due to which the guide rod together with the seton can move freely along the fistula canal.

In addition, at the first stage of treatment on an outpatient basis, a thin latex or vicryl seton was installed in the fistulous passage using the developed device. At the second stage of treatment, 50-90 days later, after relief of the signs of a purulent-inflammatory process and eruption of the tissue bridge of the sphincter with a ligature, a radical surgical intervention was performed (controlled excision of the fistula) ..

Optimal establishment of a seton in the anorectal fistulous canal using the device we offer on an outpatient basis at the first stage of treatment leads to a rapid regression of the infectious and inflammatory process, reduces tissue edema and hyperemia, and also contributes to the "straightening" of the convoluted fistulous tract by cutting the tissue bridge of the sphincter with a seton with migration of the internal opening of the fistula in the caudal direction. This, in turn, greatly simplifies the technique of excision of the fistulous course at the second stage of treatment, makes it less traumatic, which reduces the risk of postoperative complications (primarily anal sphincter insufficiency) and recurrence of the disease, and also significantly shortens the healing time of the postoperative wound.

A detailed description of the seton device for the treatment of patients with chronic paraproctitis and clinical examples of its use.

At the preoperative stage, in patients with chronic paraproctitis complicated by the formation of anorectal fistulous tract, anamnesis, objective physical and instrumental examination (anascopy, sigmoidoscopy, sphincterometry, STIR MRI mode, fistulography) are carried out. In order to objectively assess the state of the external and internal sphincter of the rectum, sphincterometry is performed. The sphincterometer S4401 (Germany) is used.

In the preoperative period on an outpatient basis, the following medical procedures were used.

On an outpatient basis, in the position of the patient on the left side (in the embryo position), after preliminary treatment of the surgical field with a disinfectant solution under local anesthesia, a solution of ultracaine through the external opening of the fistulous passage into the anorectal fistula, a latex or vicryl drainage (seton, seton) with a diameter of 2-0 was installed. The seton was inserted into the fistulous canal using a special device developed by us for this purpose (Figure 1).

The device is a metal tool that consists of a handle (1) and a working part. The handle of the device measuring 8.0 × 2.0 cm is made of hard, inflexible metal in the form of a hexagon with a rough surface that prevents slipping when working with the tool. The working part of the device 8 cm long is made of a flexible and thin metal in the form of a round guide rod with a diameter of 2.0 mm (2), The material and design of the rod allow it to bend its shape in accordance with the topographic and anatomical course of the fistulous canal. ) there is an extension in the form of a thin oblong loop (resembling the "eye" of a sewing needle) measuring 3.0 × 0.3 mm with a hole in the center with a diameter of 2.0 mm (3) through which latex or vicryl 2-0 seton freely passes. In this case, the seton is passed into the loop of the device in the same way as the thread is threaded into the eye of the sewing needle. The distal part of the loop ends with an elongated elastic olive (4), due to which the guide rod along with the seton moves unhindered along the fistula canal.

Before performing the manipulation (setting the seton into the anorectal fistula), on the basis of the patient's examination results (primarily fistulography and MRI data), the diameter, length, topographic and anatomical characteristics, the severity of bends and branching and other features of the fistulous canal were carefully assessed and analyzed. Due to the flexibility of the metal, the working part of the device (guide rod) was modeled by bending so that its shape clearly corresponded to the topographic and anatomical course of the fistulous canal. Consequently, the passage of the proposed device through the fistulous canal was strictly individualized for each individual patient with chronic paraproctitis, which, of course, significantly increased the effectiveness of this manipulation.

The device was passed through the external opening of the fistulous tract into the internal one. At the same time, due to the flexibility of the metal, the working part of the tool easily and without hindrance passed all the irregularities and bends of the fistulous course. The end of the instrument was brought out through the internal opening of the fistula into the lumen of the rectum. In this case, the index finger of the surgeon's left hand, introduced previously into the lumen of the rectum, easily identifies and "meets" the metal olive of the working part of the device.

After removing the working part of the device together with the loop outside the anus, a latex or vicryl seton 2.0 (by the type of threading into the eye of a sewing needle) was introduced into the hole of the metal loop, which was fixed there with several interrupted sutures. After that, the device was removed in reverse order together with a latex or vicryl seton fixed to it. Then the thread was removed from the instrument, fixed, perhaps more correctly: it was tonically tightened around the fistulous passage and left in the wound for an average of 50-80 days, which, in addition to visual determination of the amount of the involved sphincter muscle, facilitated drainage of the fistula, stimulation of fibrosis, and gradual eruption of the fistula.

At the second stage of anal fistula treatment, fistulotomy was performed. The method consists in dissecting the fistulous tract along the entire length, forming an open wound. After that, spontaneous healing of the resulting wound defect occurred.

The criteria for the effectiveness of treatment are the elimination or decrease in the intensity of the pain syndrome due to a decrease in the pyoinflammatory process, a decrease in the patient's stay in the hospital at the second stage, high physical activity and the patient's ability to work in the early postoperative period, the absence of complications in the early and late postoperative periods, as well as excellent subjective assessment of his general condition by the patient himself.

The need to apply the claimed invention is confirmed by the following clinical examples.

Clinical example 1.

Patient K-ev, 56 years old, case history No. 4-40699, was admitted to the coloproctology department on 04/07/18 with complaints of pain in the anus after the act of defecation, discharge of pus and blood from the rectum. From the anamnesis it is known that he has been ill for about 3 weeks, the disease was preceded by hypothermia. Upon admission, the patient's condition is of moderate severity, the skin is pale pink in color. In the lungs on both sides, hard breathing, no wheezing. The respiratory rate is 18 per minute. Blood pressure is 140/90 mm Hg. Art., heart rate - 77 per minute. Tongue moist, coated with white bloom. On palpation, the abdomen is soft, painless in all parts. In a local examination, the anal area without pathological changes, at 12 o'clock of the conditional dial in the supine position in the anal canal, an anal fissure with dimensions of 1.2 × 0.4 × 0.3 cm, with scar edges and a "sentinel tubercle" is determined. An internal opening of the sinus tract opens into the bottom of the crack (at the level of the "jagged line"). The external opening of the fistulous course at 13 o'clock, 3 cm from the anus. Rectal examination is painful, the tone of the sphincter is increased. Sphincterometry indices: mean resting pressure 69 mm Hg. Art., the average value with volitional contraction is 132 mm Hg. Art.

A patient on an outpatient basis on 04/07/18 in the position on the left side (in the embryo position) after preliminary treatment of the surgical field with a disinfectant solution under local anesthesia of an ultracaine solution into the external opening of the fistulous passage using a device developed by us was introduced a permanent drainage (seton, seton) with a diameter 2-0. This was done using a product that is a metal tool made of flexible metal with a working part length of 10 cm and a diameter of 2 mm. At the end of the working part of which there was an olive-style expansion 0.7 × 0.3 (resembling the "eye" of a sewing needle) in the center of which there was a hole with a diameter of 2 mm, through which a thread of 2.0 passed freely. The instrument for carrying out the ligature was passed through the outer opening of the fistulous passage into the inner one, thanks to the flexible metal, the working part of the instrument easily passed the irregularities and bends of the fistulous course. The end of the probe was brought out through the internal opening into the rectal lumen. The index finger of the surgeon's left hand was in the lumen of the intestine and met the probe.

After the working part of the instrument with an olive-like extension of 0.7 × 0.3 (resembling the "eye" of a sewing needle) with a hole in the center with a diameter of 2 mm outside the anus, a 2-0 drainage ligature was inserted into the hole and fixed there with several nodal seams. Then the instrument was removed in reverse order together with the ligature fixed to it. Then the thread was removed from the instrument, and fixed (tied) around the fistulous passage and left in the wound for 70 days, which, in addition to visual determination of the amount of the involved sphincter muscle, facilitated drainage of the fistula, stimulation of fibrosis and gradual eruption of the fistula.

On June 17, 18, surgical treatment was performed in the amount of excision of a chronic anal fissure and fistulotomy of the fistulous passage using the "Surgitron" apparatus.

In the position of the patient on the left side (in the embryo position), after preliminary treatment of the operating field with a disinfectant solution, the probe was introduced into the canal through the external opening of the fistula, parallel to the previously installed Seton drainage, then with the Surgitron apparatus in the 30-watt expansion mode and 40-watt coagulation mode tissue before opening the lumen throughout the fistula.

The wound remained open in an area 1-2 cm long near the external opening with excision of the adjacent skin, which accelerated the healing of the canal and prevented premature closure of the external opening.

The postoperative period was uneventful with moderate pain. The patient was discharged from the "day hospital" on the 10th day. The wound with signs of epithelialization, the act of defecation is moderately painful. A follow-up examination 1 month after the operation did not reveal any data for a relapse of the disease, no other anorectal pathology was found, the patient was able to work. The patient rated his state of health on the scale of the general clinical impression as "great improvement". 6 months after discharge, the follow-up examination did not reveal any data for a relapse of the disease.

Clinical example 2.

Patient A-va, 42 years old, case history No. 4-41293, was admitted to the coloproctology department on 12.07.18 with complaints of pain in the anus after the act of defecation, discharge of pus and blood from the rectum. From the anamnesis it is known that he has been ill for about 10 days, the disease was preceded by hypothermia. Upon admission, the patient's condition is of moderate severity, the skin is pale pink in color. In the lungs on both sides, hard breathing, no wheezing. Respiratory rate - 17 per minute. Blood pressure - 130/80 mm Hg. Art., heart rate - 71 per minute. Tongue moist, coated with white bloom. On palpation, the abdomen is soft, painless in all parts. Local examination of the anal area without pathological changes, at 6 o'clock of the conditional dial in the supine position in the anal canal, an anal fissure with dimensions of 1.5 × 0.3 × 0.2 cm, with scar edges and a "sentinel tubercle" is determined. An internal opening of the sinus tract opens into the bottom of the crack (at the level of the "jagged line"). The external opening of the fistulous course at 7 o'clock, 4 cm from the anus. Rectal examination is painful, the tone of the sphincter is increased. Sphincterometry indices: mean resting pressure 70 mm Hg. Art., the average value with volitional contraction - 129 mm Hg. Art.

A patient on an outpatient basis on 07/13/18 in the position on the left side (in the embryo position) after preliminary treatment of the operating field with a disinfectant solution under local anesthesia of an ultracaine solution into the external opening of the fistulous passage using a device developed by us, a permanent drainage (seton, seton) with a diameter 2-0. This was done using a product that is a metal tool made of flexible metal with a working part length of 10 cm and a diameter of 2 mm. At the end of the working part of which there was an olive-style expansion 0.7 × 0.3 (resembling the "eye" of a sewing needle) in the center of which there was a hole with a diameter of 2 mm, through which a thread of 2.0 passed freely. The instrument for carrying out the ligature was passed through the outer opening of the fistulous passage into the inner one, thanks to the flexible metal, the working part of the instrument easily passed the irregularities and bends of the fistulous course. The end of the probe was brought out through the internal opening into the rectal lumen. The index finger of the surgeon's left hand was in the lumen of the intestine and met the probe.

After the working part of the instrument with an olive-like extension of 0.7 × 0.3 (resembling the "eye" of a sewing needle) with a hole in the center with a diameter of 2 mm outside the anus, a 2-0 drainage ligature was inserted into the hole and fixed there with several nodal seams. Then the instrument was removed in reverse order together with the ligature fixed to it. Then the thread was removed from the instrument, and fixed (tied) around the fistulous passage and left in the wound for 70 days, which, in addition to visual determination of the amount of the involved sphincter muscle, facilitated drainage of the fistula, stimulation of fibrosis and gradual eruption of the fistula.

On 28.08.18, surgical treatment was performed in the amount of excision of a chronic anal fissure and fistulotomy of the fistulous passage using the "Surgitron" apparatus.

In the position of the patient on the left side (in the embryo position), after preliminary treatment of the operating field with a disinfectant solution, the probe was introduced into the canal through the external opening of the fistula, parallel to the previously installed Seton drainage, then with the Surgitron apparatus in the 30-watt expansion mode and 40-watt coagulation mode tissue before opening the lumen throughout the fistula.

The wound remained open in an area 1-2 cm long near the external opening with excision of the adjacent skin, which accelerated the healing of the canal and prevented premature closure of the external opening.

The postoperative period was uneventful with moderate pain. The patient was discharged from the "day hospital" on the 10th day. The wound with signs of epithelialization, the act of defecation is moderately painful. A follow-up examination 1 month after the operation did not reveal any data for a relapse of the disease, no other anorectal pathology was found, the patient was able to work. The patient rated his state of health on the scale of the general clinical impression as "great improvement". 6 months after discharge, the follow-up examination did not reveal any data for a relapse of the disease.

The method was tested on the clinical basis of the Department of General Surgery of the Rostov State Medical University in 87 patients with chronic paracotitis complicated by the formation of a fistulous tract. The control group consisted of 95 patients who underwent traditional surgical treatment without the use of Seton drainage.

Results: no recurrence of the disease after surgery in the main group of patients (in the control group, 19 patients had a relapse of paraproctitis and fistulous tract), halving the time of postoperative wound healing in patients of the main group compared with the control group of patients. In patients of the main group, working capacity is restored on days 2-3 after the operation (on average, 2.1 ± 0.4 days), while in the control group of patients this indicator ranged from 5 to 14 days (on average - 9.4 ± 1.8 days). At the same time, the subjective assessment of their well-being by the patients of the main group in the early and late postoperative periods was interpreted as “good” and “very good”.

Thus, after the installation of the Seton drainage with the help of the instrument developed by us for carrying out the drainage, the suppression of the pyoinflammatory process and the transfer of a complex fistula to a straight line in the preoperative period were noted in patients with chronic paraproctitis complicated by the formation of a fistulous course and their adequate correction can significantly improve the results of surgical treatment of this category of patients and reduce the time of postoperative wound healing at the second stage.

The analysis of the results obtained showed that the use of the seton drainage instrument proposed by us in patients with chronic paraproctitis complicated by the formation of transsphincteric or extrasphincteric rectal fistulas can significantly reduce the number of complications and relapses of the disease (almost completely exclude them), which undoubtedly contributes to an increase in the effectiveness of treatment.

The use of the tool developed by us contributes to an increase in the effectiveness of treatment of patients with chronic paraproctitis, complicated by the formation of transsphincteric or extrasphincteric fistulas of the rectum. Its use makes it possible to improve the results of treatment of patients in this group due to the low trauma of the drainage procedure of the fistulous tract at the first stage, the absence of hospitalization and general anesthesia, as well as a significant reduction in the number of complications and relapses of the disease in the early and late postoperative periods due to the relief of the purulent-inflammatory process and reducing the intensity of pain. This is also confirmed by a decrease in the length of hospital stay at the second stage of treatment, their high working capacity in the early postoperative period and an excellent subjective assessment of their general condition by the patients themselves.

When attempting the classical installation of the Seton drainage in patients with complex anorectal fistulas with a narrow and convoluted canal without the proposed instrument, significant difficulties arose, and it was practically impossible to perform this. This significantly complicates the use of the ligature method of treatment, which is the most optimal and only possible in patients with high transesphincteric fistulas and complex extrasphincteric fistulas of the rectum.

We propose a special device that allows you to easily and easily install a latex or vicryl seton into an anorectal fistula of any complexity, which greatly simplifies and increases the effectiveness of the ligature method in this category of patients. This once again emphasizes the advantages of this device, which, due to the flexibility of the working part of the instrument, can be modeled individually for each patient in accordance with the anatomical course of the fistulous canal of any complexity.

List of used literature

1. Gottgens K. W., Smeets R. R., Stassen LP. et al. Systematic review and meta-analysis of surgical interventions for high cryptoglandular perianal fistula. Intern. J. Colorectal Dis. 2015; 30 (5): 583-593.

2. Charyshkin A.L., Soldatov A.A., Dementyev I.N. Comparative results of surgical treatment of patients with chronic paraproctitis. Ulyanovsk Medical Biol. f. 2013; (1): 70.

3. Karpukhina O.Yu., Sakulina KA, The use of a rubber seton in the treatment of anorectal fistulas. Kazan. 2018; 326.

4. Muravyov A.V., Malyugin B.C., Linchenko V.I., Khalin D.A. Comparative evaluation of surgical treatment of extrasphincteric rectal fistulas. Honey. vestn. North Caucasus. 2013; (2): 34-36.

5. Vatansev C., Alabaz O., Tekin A. et al. A new seton type for the treatment of anal fistula. Dig. Dis. Sci. 2007; 52 (8): 1920-1923. doi: 10.1007 / s10620-007-9793-5.

6. Shelygin Yu.A. Clinical guidelines. Coloproctology. M .: GEOTAR-Media. 2015; 82-107.

7. Hippocrates. On Fistulae. Translated by F. Adams. The Internet Classics Archive by Daniel C. Stevenson, Web Atomics. http://classics.mit.edU/Hippocrates/fistulae.4.4.html (access date: 10/30/2017).

8. Subhas G., Singh Bhullar J., Al-Omari A. et al. Setons in the treatment of anal fistula: review of variations in materials and techniques. Dig. Surg. 2012; 29 (4): 292-300.

doi: 10.1159 / 000342398.

9. Mosby's medical dictionary. 8th edition. Elsevier. 2009: 2240 p.S.v. Seton. https://medical-dictionary.thefreedictionary.com/seton (access date: 10/30/2017).

Claims (1)

A device for the treatment of chronic paraproctitis, complicated by the formation of transsphincteric or extrasphincteric fistulas of the rectum, characterized in that it consists of a handle and a working part, while the handle of the device is made of a hard inflexible metal in the form of a hexagon with a rough surface that prevents slipping when working with the instrument, and the working part of the device is made with the possibility of modeling its shape by bending in accordance with the topographic and anatomical course of the fistulous canal, while the working part is made of flexible metal in the form of a round guide rod with a diameter of 2.0 mm, at the end of which there is an extension in the form of an oblong loops measuring 3.0 × 0.3 mm with a hole in the center with a diameter of 2.0 mm for threading a latex or vicryl seton 2.0; the distal part of the loop is completed with an elongated elastic olive, due to which the guide rod together with the seton can move freely along the fistula canal.

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