RU2843886C1 - Method of treating vaginal prolapse, accompanied by isolated rectocele - Google Patents

Abstract

FIELD: medical science.

SUBSTANCE: invention refers to medicine, namely to surgical gynaecology. That is followed by combined anaesthesia, tissue hydropreparation with solution containing 0.9% NaCl and 1% lidocaine. Linear incision is made along a posterior vaginal wall in suprafascial and subfascial spaces. Subfascial space is dissected laterally from vaginal walls; a rectovaginal fascia is visualised. Existing fascial defect is corrected by implanting the Lioplast bioimplant. Defect of the rectovaginal fascia is eliminated by suturing it with separate U-sutures. That is followed by the lateral dislocation of the fascia and its repeated plication in the medial portion of the fascia in the same way. Then medial portions m. puborectalis are sutured after mobilizing the edges of the levator complex. That is followed by a resection of not more than 5 mm of the excessive mucosa of the posterior vaginal wall to be closed. Anatomical integrity of the perineum is gradually restored.

EFFECT: method enables reducing intraoperative injuries, considerably reducing a probability of recurrences and constipation symptom severity, as well as improving the postoperative functional outcome.

1 cl, 2 dwg, 2 ex

Description

Field of technology

The invention relates to the field of medicine, namely to surgical gynecology, and can be used for reconstructive plastic surgery in women with prolapse of the posterior vaginal wall, accompanied by isolated rectocele.

State of the art

Rectocele, which is part of the broader category of pelvic organ prolapse, is a common entity that significantly reduces women's quality of life. According to a study by Nygaard et al., approximately 2.9% of women experience symptoms suggestive of pelvic organ prolapse [1]. Dietz et al. found that 48% of the women examined had a rectocele on transperitoneal ultrasound, with the prevalence increasing significantly with the number of vaginal deliveries [2]. It should be noted that even among nulliparous women, traditionally considered a low-risk group, significant posterior vaginal prolapse was observed in 29% [3].

Despite the variety of surgical approaches to the treatment of rectocele and related conditions, existing techniques demonstrate insufficient effectiveness. The recurrence rate after surgical intervention remains high, ranging from 4% to 34% in various studies [4-6]. An analysis by Maher et al., which covered 56 randomized controlled trials involving 5954 women, showed that even with the most effective techniques of posterior vaginal repair, the risk of rectocele recurrence remains up to 30% [7]. A systematic review by Mowat et al. confirmed that regardless of the chosen approach - transvaginal or transanal - the problem of recurrence remains relevant [8]. These data indicate the need to develop new, more effective methods of surgical treatment aimed at improving anatomical and functional results, as well as reducing the risk of recurrence and improving the quality of life of patients.

A method for surgical treatment of rectocele using the puborectalis muscle is known (RU Patent 2752027C1, 2021.07.22). Posterior colpoperineolevatoroplasty is performed. Additionally, the puborectalis muscle is isolated, the puborectalis muscle and the retracted perirectal fascia are brought together with 3-5 absorbable sutures, capturing the tissue in the sutures as far as possible in the lateral direction, and immersing the rectum with a finger until a 4 cm long tissue plate is formed above the anterior wall of the rectum. The method allows for the correction of rectocele without the use of a mesh implant, prevents late postoperative complications in the form of recurrent rectal prolapse.

The disadvantages of this method are:

• Limited attention to working with disorders of the anatomy of fascial structures, which may not ensure optimal correction of the identified anatomical defects.

• Potentially higher trauma of the intervention due to the lack of preliminary tissue preparation before dissection.

• Absence of a stage of correction of excess vaginal tissue, which can negatively affect the cosmetic result and functionality in the postoperative period.

A method for treating vaginal prolapse accompanied by rectocele is known (variants, Russian Federation patent 2269317C1, 2006.02.10). A triangular flap is excised from the posterior vaginal wall. Corrugated sutures are applied to the anterior wall of the rectum. The levators are brought together by applying sutures. In this case, according to the first variant, titanium fixators are inserted by the levators on each side using a guide. Each of the fixators is connected to a ligature. The fixators are fixed in the anorectal tissue by the levators. Corrugated sutures are applied with the free ends of the ligatures. The ends of the threads are tied together.

The disadvantages of this method are:

• Use of non-absorbable titanium retainers, which may lead to long-term complications such as chronic pain, vaginal erosion or infection.

• Excision of a triangular flap can be overly traumatic and does not always provide optimal correction of anatomical defects, increasing the risk of dyspareunia.

• The absence of a preliminary tissue preparation stage can complicate the dissection process and increase the risk of intraoperative complications.

A method for one-stage correction of rectocele in combination with apical prolapse is known (RF 2732875, 2019.11.05), which includes hydrodissection of the posterior vaginal wall, formation of rectangular sheets from the vaginal mucosa, fixation of a synthetic implant to the posterior wall of the cervix and sacrospinal ligament, formation of neofascia using argon plasma coagulation and suturing it to the opposite sheet.

• Excessive excision of the vaginal mucosa with the formation of neofascia may contribute to circulatory disorders and serve as a predictor for the recurrence of genital prolapse, as well as dyspareunia.

• The use of a synthetic implant may lead to complications such as erosion of the vaginal mucosa, infection or chronic pain syndrome.

• Formation of neofascia using argon plasma coagulation can cause excessive scarring and impaired tissue elasticity.

• The method is overly traumatic due to multiple incisions and manipulations.

• Fixation of the implant to the sacrospinal ligament can be a technically challenging and potentially dangerous procedure, increasing the risk of intraoperative complications associated with injury to the pelvic organs.

The technical problem solved by the claimed invention is the need to overcome the shortcomings inherent in analogues by creating a method of surgical treatment of rectocele with a low recurrence rate and high anatomical and functional results.

Disclosure of invention

The technical result of the claimed method is to reduce the trauma of the operation, improve the anatomical and functional results and reduce the frequency of relapses in the surgical treatment of rectocele. The effectiveness of the method is confirmed by the following results:

• Reduction in the severity of constipation symptoms: the average score on the Wexner constipation scale in the experimental group decreased from 17.3±2.4 to 11.9±1.8 6 months after surgery, which corresponds to a 1.5-fold improvement in functional treatment outcomes. In the control group, where the standard technique was used, the decrease was less pronounced - from 18.7±1.3 to 17.1±1.5, which corresponds to an improvement of only 1.1 times.

• Reduction in the severity of dyspareunia: in the experimental group, the average severity of dyspareunia on the VAS scale was 4.13±2.18 6 months after surgery, while in the control group this figure reached 11.32±9.75, which demonstrates the effectiveness of the experimental technique to be 2.7 times higher than traditional methods, confirming the significantly lower trauma of the declared method.

• Reduction in relapse rate: during the 6-month observation period, no relapses were observed in the experimental group (0%), while 4 cases of relapse were recorded in the control group (10.5%). This indicates a potential reduction in the relapse rate by more than 10 times when using the claimed method.

Thus, the proposed method provides improved outcomes of rectocele treatment, characterized by a decrease in the trauma of the operation, an increase in anatomical and functional results compared to classical methods, as well as a decrease in the likelihood of dyspareunia and relapses.

The specified technical result is achieved by a method of treating prolapse of the posterior vaginal wall accompanied by rectocele, including the use of the bioimplant "Lioplast" (Lateral strip (fascia) 2x3 LIO-188) for neofasciogenesis and additional strengthening of supporting structures and stimulation of regenerative processes in the area of the Denonvilliers fascia.

The method includes performing combined anesthesia, performing hydropreparation of tissues with a solution containing 0.9% NaCl and 1% lidocaine in the suprafascial and subfascial spaces, making a linear incision along the posterior wall of the vagina, performing extensive dissection of the subfascial space from the walls of the vagina laterally to visualize the rectovaginal fascia, correcting the fascial defect by implanting the biomaterial "Lioplast" in the area of surgical intervention, then eliminating the defect by applying individual U-shaped sutures with absorbable material (1 suture per 3 mm of the detected defect), lateral displacement and plication of the medial part of the fascia using a similar method, applying individual sutures to the medial portions of m. puborectalis after mobilization of the edges of the levator complex (1 suture per 3 mm of the detected defect), partial resection of excess mucosa (no more than 5 mm) of the posterior vaginal wall with subsequent suturing and step-by-step restoration of the anatomical integrity of the perineum. In this case, the Lioplast bioimplant is fixed to the surrounding tissues with absorbable vicryl sutures to ensure its stable position (1 suture per centimeter of the implant length), and before implantation, the Lioplast biomaterial is hydrated in a sterile saline solution according to the manufacturer's recommendations. After placement of the Lioplast bioimplant and before suturing the surgical wound, an additional palpation assessment of the implant location is performed to confirm its optimal position. During the operation, continuous monitoring of the patient's condition and hemostasis are carried out.

Performing suprafascial and subfascial tissue hydrodissection reduces the risk of injury to the rectum and paravaginal vessels, as well as reduces intraoperative blood loss. This contributes to a safer and less traumatic operation.

Double plication of the fascia by applying two rows of U-shaped sutures and contralateral displacement of the medial leaflet of Denonvilliers' fascia allows for effective correction of the defect, which reduces the likelihood of relapse, dyspareunia and improves anatomical and functional results.

The proposed method for treating posterior vaginal wall prolapse accompanied by rectocele includes the use of the bioimplant "Lioplast" for additional strengthening of supporting structures and stimulation of regenerative processes. A longitudinal incision on the mucosa facilitates the most anatomical verification of the defect of the Denonvilliers pelvic fascia and the absence of complete excessive excision of the vaginal mucosa allows to reduce the likelihood of dyspareunia in the postoperative period.

The combination of these techniques ensures optimal anatomical correction, improved functional results and increased quality of life for patients with rectocele. The use of the bioimplant "Lioplast" allows achieving full neofasciogenesis and promotes more reliable tissue fixation and reduces the risk of relapses of the disease.

An integrated approach, including atraumatic dissection, effective correction of the fascial defect and the use of modern biocompatible materials, allows for improvement in both anatomical and functional parameters in the anti-relapse treatment of rectocele.

Brief description of the drawings.

The invention is illustrated by the following illustrative material.

Fig. 1 shows a schematic representation of the stages of the operation (A-G): wide dissection of the subfascial space from the vaginal walls in lateral directions from the incision in order to isolate the anatomy of the Galban pubocervical fascia; placement of the Lioplast bioimplant similar to the identified defect after its intraoperative verification of the fascial defect in order to replace it by fixing it with separate interrupted Vicryl sutures; U-shaped sutures to eliminate the fascial defect, second plication of the fascia with U-shaped sutures, suturing of the mucosa.

Fig. 2 shows the anatomical arrangement of structures after rectocele correction using the bioimplant "Lioplast". The vagina is shown in pink at the top. Below it, the bioimplant "Lioplast" is highlighted in green, located between the vagina and the restored fascia (gray line). The rectum, shown in brown, is tightly adjacent to the fascia from below. All structures are located within the beige contour of the body.

Implementation of the invention

The method of surgical treatment of rectocele using the bioimplant "Lioplast" includes the following stages: administration of combined anesthesia; performance of tissue hydropreparation with a solution containing 0.9% NaCl and 1% lidocaine in the suprafascial and subfascial spaces; performance of a linear incision along the posterior wall of the vagina approximately 8.0 cm long; performance of extensive dissection of the subfascial space from the walls of the vagina laterally for visualization of the rectovaginal fascia; placement of the bioimplant "Lioplast" similar to the detected defect after its intraoperative verification of the fascial defect in order to replace it by fixing it with individual interrupted sutures (a single suture applied in the vertical plane for apposition and immobilization of the wound edges, due to the ease of application, hemostatic effect, the possibility of good adaptation of the wound edges) made of vicryl. Optimal positioning of Lioplast bioimplants taking into account individual anatomical features of each patient according to verified defects of Denonvilliers' fascia. Correction of Denonvilliers' fascial defect by applying a series of separate U-shaped sutures (refers to horizontal ones, puncture and extrusion are performed symmetrically, at the same distance from the wound edge and from each other) with absorbable material; lateral displacement and second plication of the medial part of the fascia using a similar method; application of separate sutures to the medial portions of m. puborectalis after mobilization of the edges of the levator complex; partial resection of excess mucous membrane of the posterior vaginal wall no more than 5 mm with subsequent suturing; staged restoration of the anatomical integrity of the perineum. Before implantation, Lioplast biomaterial is hydrated in sterile saline according to the manufacturer's recommendations, then fixed to the surrounding tissues with absorbable Vicryl sutures to ensure its stable position. During the operation, the patient's condition is continuously monitored and hemostasis is controlled. After the placement of the "Lioplast" bioimplant and before suturing the surgical wound, an additional palpation assessment of the implant location is performed to confirm its optimal position (signs of an optimal position are: no tension, free position of the implant on the surface of the fascia, no significant elevation of the implant above the level of the surrounding fascia). A schematic representation of the stages of the operation is shown in Fig. 1, Fig. 2 shows the anatomical location of the structures after rectocele correction.

According to the conducted study, the developed method of surgical treatment of vaginal prolapse accompanied by rectocele is characterized by technical simplicity, good anatomical and functional effect and low frequency of adverse events in the early and late postoperative periods, low frequency of relapses and dyspareunia.

As part of a preliminary study of a new method of surgical treatment of vaginal prolapse accompanied by rectocele, using Lioplast bioimplants, treatment was carried out using the claimed method and observation of 10 patients for 6 months after surgery.

The study included 10 women aged 35 to 45 years (mean age 41.2±2.8 years) with a clinically verified diagnosis of pelvic floor muscle failure, prolapse of the posterior vaginal wall with rectocele formation (ICD10 codes - N81.6). All patients had a detailed medical history, complaints were assessed, and a comprehensive perineological examination was performed. The severity of constipation was assessed using the Wexner constipation scale. The severity of dyspareunia was assessed using the visual analogue scale (VAS).

For comparative analysis, data from the control group (n=38) were used, where patients underwent standard posterior colporrhaphy with perineolevatorplasty.

The operation was performed in the stated manner on patients in the experimental group. The distinctive features of this method are:

• Suprafascial and subfascial tissue hydrodissection, which helps reduce the risk of injury to the rectum and paravaginal vessels, as well as reduce intraoperative blood loss.

• Use of Lioplast bioimplants for the formation of neofasciogenesis.

• Optimal positioning of Lioplast bioimplants taking into account the individual anatomical features of each patient according to verified defects of the Denonvilliers fascia.

• Double plication of the fascia by applying two rows of U-shaped sutures, which provides more reliable fixation and strengthening of the Denonvilliers fascia.

• Contralateral displacement of the medial fascial leaflet for optimal correction of the fascial defect.

• Performing a longitudinal incision on the vaginal mucosa with minimal tissue excision, which helps to maintain the natural elasticity of the vagina.

The use of Lioplast bioimplants in combination with the described surgical technique is aimed at reducing the likelihood of relapses, reducing the severity of symptoms of constipation and dyspareunia, and improving anatomical and functional results.

Results:

Group using "Lioplast" (n=10)

1. There were no early or late postoperative complications.

2. During the observation period (6 months), no recurrences of prolapse of the posterior vaginal wall with the formation of rectocele were recorded.

3. All patients noted a significant improvement in quality of life and a reduction in symptoms associated with rectocele.

Comparison with control group

For comparison, data from the control group 6 months after standard surgery were used:

1. Recurrence rate in the control group: 4 cases (10.5%) after 6 months.

2. Average values of indicators in the control group after 6 months:

• Wexner Constipation Scale: 17.1±1.5

• VAS scale (dyspareunia): 11.32±9.75

In the group using Lioplast, a tendency towards better indicators was noted:

• Wexner Constipation Scale: mean 11.9±1.8

• VAS scale (dyspareunia): mean value 4.13±2.18

The results of the application of the new method using Lioplast bioimplants demonstrate encouraging trends:

1. No relapses during 6 months of observation.

2. Lower mean Wexner Constipation Scale and Dyspareunia VAS scores compared to the control group, indicating better functional outcomes.

3. The absence of postoperative complications, which indicates high anatomical and safety of the method.

The results of the application of a new method of surgical treatment of rectocele using bioimplants "Lioplast" demonstrate potential advantages in reducing the frequency of relapses, achieving high anatomical and functional results in comparison with the standard method.

Clinical example 1.

Patient A., 43 years old, with a history of 2 vaginal births, has been suffering from prolapse of the posterior vaginal wall, accompanied by rectocele, for 5 years. She complained of difficult defecation, a feeling of incomplete bowel movement, and discomfort in the vagina.

St. localis: The external genitalia are developed correctly, according to the female type. When straining, the genital slit gapes, the posterior wall of the vagina protrudes at the level of introitus vaginae. Signs of a rectocele of the second degree have been established.

The patient underwent surgery according to the stated method. The course of the surgery:

Under combined anesthesia against the background of suprafascial and subfascial tissue hydrodissection with a solution containing 0.9% NaCl (20 ml) and 1% lidocaine (2 ml), a linear incision was made along the posterior vaginal wall. A thorough and extensive dissection of the subfascial space from the vaginal walls laterally was performed to visualize the rectovaginal fascia. After intraoperative confirmation of the presence of the Denonvilliers fascial defect, the Lioplast bioimplant was placed similarly to the identified defect in order to replace it and fixed with separate interrupted Vicryl sutures. Before implantation, the Lioplast biomaterial was hydrated in a sterile saline solution according to the manufacturer's recommendations, then fixed to the surrounding tissues with absorbable sutures to ensure its stable position. The defect was corrected by applying a series of individual U-shaped sutures using absorbable suture material. Then, the medial part of the fascia was laterally displaced and plicated using a similar method. After mobilizing the edges of the levator complex on both sides, individual sutures were applied to the medial portions of m. puborectalis.

Partial resection of excess mucous of the posterior vaginal wall (4 mm) was performed, followed by suturing with a continuous suture. Step-by-step restoration of the anatomical integrity of the perineum was performed, including correction of the tendinous center and the complex of superficial and deep transverse muscles of the perineum.

During the operation, the patient's condition was continuously monitored and hemostasis was controlled. After the placement of the "Lioplast" bioimplant and before suturing the surgical wound, an additional palpation assessment of the implant location was performed to confirm its optimal position.

Total blood loss: 80.0 ml.

In the postoperative period, the patient was active from the first day. She received a course of antibacterial therapy and symptomatic treatment. The postoperative period was uneventful. The sutures on the mucous membrane are in satisfactory condition, without edema and hematomas, defecation is independent, painless, the wound heals by primary intention. She was discharged in satisfactory condition for further outpatient observation by a doctor of the women's clinic (polyclinic) at the place of residence.

After 3 months, a control examination of the patient was performed. The condition is satisfactory. No complaints. The genital slit is closed, the vaginal walls are intact when straining, the vagina is passable for 2 transverse fingers, a dense painless postoperative scar was palpated along the back wall of the vagina. Defecation is free, painless.

The patient was re-examined 6 months later. Her condition was satisfactory. No complaints. The genital slit did not gape during straining, the vagina was passable for 2 transverse fingers, and a dense, painless postoperative scar was palpated along the posterior vaginal wall. There was no difficulty in defecation or a feeling of incomplete bowel evacuation. According to the questionnaire using the Wexner Constipation Scale and the VAS scale for assessing dyspareunia, a significant decrease in the severity of symptoms was noted compared to the preoperative level. The Wexner Constipation Scale score decreased from 18 to 9 points, and the VAS scale for assessing dyspareunia decreased from 5 to 2 points.

Clinical example 2.

Patient V., 47 years old, with a history of 3 vaginal births, has been suffering from prolapse of the posterior vaginal wall, accompanied by rectocele, for 7 years. She complained of the need for manual assistance during defecation, a feeling of incomplete bowel movement, discomfort in the vagina and pain during intercourse.

St. localis: The external genitalia are developed correctly, according to the female type. When straining, the genital slit gapes, the posterior wall of the vagina protrudes 2.5 cm from the introitus vaginae. Signs of a grade III rectocele have been established.

The patient underwent surgery according to the stated method. The course of the surgery:

Under combined anesthesia, hydropreparation of tissues was performed with a solution containing 0.9% NaCl (20 ml) and 1% lidocaine (2 ml) in the suprafascial and subfascial spaces. A linear incision was made along the posterior wall of the vagina. A thorough and extensive dissection of the subfascial space from the vaginal walls laterally was performed to visualize the rectovaginal fascia.

After intraoperative verification of the Denonvilliers fascial defect, the Lioplast bioimplant was placed similarly to the identified defect in order to replace it. Before implantation, the Lioplast biomaterial was hydrated in sterile saline according to the manufacturer's recommendations, then fixed to the surrounding tissues with absorbable sutures to ensure its stable position. The defect was corrected by applying a series of individual U-shaped sutures using absorbable suture material. Lateral displacement of the medial part of the fascia and its plication were performed using a similar method. After mobilization of the edges of the levators on both sides, individual sutures were applied to the medial portions of m. puborectalis.

Partial resection of excess mucous of the posterior vaginal wall (3 mm) was performed, followed by suturing with a continuous suture. Step-by-step restoration of the anatomical integrity of the perineum was performed, including correction of the tendinous center and the complex of superficial and deep transverse muscles of the perineum.

Throughout the operation, the patient's condition was continuously monitored and hemostasis was controlled. After the placement of the "Lioplast" bioimplant and before suturing the surgical wound, an additional palpation assessment of the implant location was performed to confirm its optimal position.

Total blood loss: 90.0 ml.

In the postoperative period, the patient was activated from the second day. A course of antibacterial therapy and symptomatic treatment were administered. The postoperative period was uneventful. The sutures on the mucous membrane are in a satisfactory condition, without signs of inflammation and hematomas, defecation is independent, painless, the wound heals by primary intention. On the 3rd day, the patient was discharged in a satisfactory condition for further outpatient observation by a doctor at the women's clinic (polyclinic) at the place of residence.

A follow-up examination of the patient was performed after 3 months. The condition is satisfactory. No complaints. The genital slit is closed, the vaginal walls are intact when straining, the vagina is passable for 2 transverse fingers, a dense painless postoperative scar was palpated along the posterior wall of the vagina. Defecation is free, painless, without the need for manual assistance.

The patient was examined again after 6 months. Her condition was satisfactory. There were no complaints. The genital slit did not gape during straining, the vagina was passable for 2 transverse fingers, and a dense, painless postoperative scar was palpated along the posterior vaginal wall. There was no difficulty in defecation, a feeling of incomplete bowel emptying, or the need for manual assistance. According to the questionnaire using the Wexner Constipation Scale and the VAS dyspareunia scale, there was a significant decrease in the severity of symptoms compared to the preoperative level. The Wexner Constipation Scale score decreased from 20 to 8 points, and the VAS dyspareunia score decreased from 5 to 1 point. The patient noted complete satisfaction with the results of the surgery and a significant improvement in the quality of her sexual life.

Bibliography:

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2. Dietz HP, Gómez M, Atan IK, Ferreira CSW. Association between vaginal parity and rectocele. Int Urogynecol J. 2018 Oct;29(10):1479-1483. doi:10.1007/s00192-017-3552-8. Epub 2018 Feb 20. PMID: 29464300.

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Claims (5)

1. A method for treating prolapse of the posterior vaginal wall accompanied by a rectocele, characterized by the fact that combined anesthesia is administered, tissue hydropreparation is performed with a solution containing 0.9% NaCl and 1% lidocaine, a linear incision is made along the posterior vaginal wall in the suprafascial and subfascial spaces, the subfascial space is dissected laterally from the vaginal walls, the rectovaginal fascia is visualized, the existing fascial defect is corrected by implanting a Lioplast bioimplant, then the rectovaginal fascia defect is eliminated by suturing it with separate U-shaped sutures, then the fascia is lateralized and re-plicated in the medial part of the fascia in a similar manner; then sutures are applied to the medial portions of the m. puborectalis after mobilization of the edges of the levator complex, then resection of no more than 5 mm of excess mucous of the posterior vaginal wall is performed with subsequent suturing, and the anatomical integrity of the perineum is gradually restored. 2. The method according to item 1, characterized in that the "Lioplast" bioimplant is fixed to the surrounding tissues with absorbable Vicryl sutures. 3. The method according to item 1, characterized in that before implantation the “Lioplast” bioimplant is subjected to hydration in a sterile physiological solution. 4. The method according to item 1, characterized in that during the operation, continuous monitoring of the patient’s condition and hemostasis control are carried out. 5. The method according to item 1, characterized in that after placement of the Lioplast bioimplant and before suturing the surgical wound, an additional palpation assessment of the location of the implant is carried out.