Method for surgical treatment of rectovaginal fistulas from area of colorectal anastomosis using reverse flap method in combination with evagination

RU2871222C1Active Publication Date: 2026-10-02FEDERALNOE GOSUDARSTVENNOE BYUDZHETNOE UCHREZHDENIE NATSIONALNYJ MEDITSINSKIJ ISSLEDOVATELSKIJ TSENTR KOLOPROKTOLOGII IMENI A N RYZHIKH MINIST ZDRAVOOKHRANENIYA ROSSIJSKOJ FEDERATSII
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Patent Information

Application Number
RU2025122382
Authority / Receiving Office
RU · RU
Patent Type
Patents
Current Assignee / Owner
Filing Date
2025-08-13
Publication Date
2026-10-02
Estimated Expiration
2045-08-13
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Abstract

FIELD: colorectal surgery.SUBSTANCE: used to treat rectovaginal fistulas (RVF) in the area of colorectal anastomosis. The anastomosis zone carrying the defect is “screwed” into the intestinal lumen, the sutures previously formed on the side of the vaginal wound are tied from the side of the intestinal lumen and the evagination zone is covered with a vaginal flap in the proximal direction. In this case, after a circular incision around the anastomosis, a cylindrical segment of the rectal wall with a fistula tract is mobilized, splitting it in the anastomosis zone in all directions. Next, separate interrupted sutures are placed longitudinally on the mobilized part of the fistula tract using a 2.0 Vicryl thread on a 5 / 8 needle; the ends of the threads are passed through the lumen of the fistula tract and tied from the side of the intestinal lumen, thus “screwing” the infected part of the tract into the lumen of the intestine or anal canal. Then, a vaginal flap is formed from the part of the rectovaginal septum distal to the anastomosis zone. The vaginal flap is shifted in the proximal direction, closing the anastomosis zone, and the flap is fixed to the proximal and lateral edges of the wound in the transverse direction without tension using separate interrupted sutures with 2.0 Vicryl thread.EFFECT: method allows to increase the frequency of healing of the RVS, indirectly improve the quality of life of patients after closure of the diverting stoma, reduce the frequency of fistula recurrence, and reduce the risk of intra- and postoperative complications.1 cl, 2 ex
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Description

[0001] The invention relates to medicine, in particular to colorectal surgery, and can be used to treat rectovaginal fistulas (RVF) in the area of ​​colorectal anastomosis.

[0002] Formation of RVC after colorectal surgery with anastomosis is a rare complication, occurring in 0.3-9.9% of cases [1-4]. Various surgical methods are used to treat RVC of this etiology (separate suturing of the vaginal and rectal walls, excision of the fistula with lowering of the rectal wall flap, excision of the fistula with lowering of the vaginal flap, Martius operation with interposition of a muscle-fat flap, as well as abdominal interventions with resection of a portion of the intestine and formation of a repeat anastomosis) [5-7]. Endoscopic methods are increasingly used as minimally invasive options - the installation of self-expanding metal stents and endoscopic clipping [8]. Despite the large number of methods used, a study of predictors of the outcome of treatment of intestinal-vaginal fistulas demonstrated that fistulas of the anastomosis zone and post-radiation RVC are associated with the least favorable outcome and a high incidence of recurrence [9].Surgical interventions are complicated by severe fibrocicatricial changes in the rectovaginal septum and colorectal anastomosis, minimal repositioning of the suture line on the intestine and vagina due to the insufficient wall thickness of the retracted portion of the intestine and the close proximity of the muscular structures of the rectal obturator apparatus, and altered blood supply and innervation in the anastomotic area. The difficulties in eliminating rectovaginal fistulas from the colorectal anastomosis area necessitate the search for more effective and safer surgical treatments for RVS in this category of patients.

[0003] The most common method described in the literature for eliminating rectovaginal septum abruption is the insertion of a rectal or vaginal flap. Researchers report a recurrence rate of 30-60% after the initial operation. However, repeated use of these methods increases the success rate but decreases the healing rate, increases the extent of fibrous scarring in the rectovaginal septum, and increases the incidence of both intra- and postoperative complications [5, 6].

[0004] Abdominal interventions with resection of a section of the intestine and formation of a repeat anastomosis in this cohort of patients demonstrate a high percentage of healing - up to 90%, however, they are recommended for high-level RBC, in the presence of a stricture above the anastomosis and in patients without severe somatic diseases that prevent anesthesia, and are also associated with a high risk of developing a pronounced adhesion process in the pelvic organs

[10] .

[0005] A known method for treating complex, recurrent rectal cysts, including those occurring within the anastomosis zone, involves separate suturing of the rectal and vaginal walls. A limitation of this technique is the need for extensive mobilization of the intestinal wall followed by repositioning of the suture line, which is difficult in patients following colon and rectal surgery with the formation of an interintestinal anastomosis due to the presence of severe cicatricial changes along the entire rectovaginal septum.

[0006] A known method for treating rectovaginal fistulas (patent No. 2739133 for the invention “Combined method for surgical treatment of rectovaginal fistulas in combination with anal sphincter insufficiency by evagination of the anterior wall of the rectum with a fistula opening, anterior sphincter levatorplasty”, IPC A61 B 17 / 42, A61 B 17 / 42, priority 04.06.2020) is the evagination method, which consists in removing the fistula tract beyond the anal canal without excision of pathological tissues and combined performance of anterior sphincter levatorplasty

[11] . This method has demonstrated high efficiency for large-diameter fistulas, but has not found wide application in RVC from the area of ​​colorectal anastomosis

[12] .

[0007] For the treatment of rectovaginal fistulas from the colorectal anastomosis area, we propose a method using a combined reverse vaginal flap and evagination. The prototypes of this surgical treatment are the evagination method for RVS and fistula excision with a vaginal flap.

[0008] The technical result of the claimed method is to improve the treatment results for patients with rectovaginal fistulas in the colorectal anastomosis zone.

[0009] Standard performance of one of the stages of the evagination method—isolating the fistula tract and inverting its walls into the lumen of the rectum or anal canal—allows for displacement of the compromised area of ​​rectal tissue and provides an intact, uninfected site for flap fixation. A well-vascularized vaginal flap, displaced and fixed proximally, provides the necessary repositioning of the suture line for healing. Furthermore, proximal flap movement in this cohort of patients resolves the problem of limited intestinal wall thickness in the area of ​​the fistula tract due to previous surgical interventions, including the formation of a colorectal anastomosis. Surgical technique

[0010] Under spinal anesthesia in the lithotomy position, after preparing the surgical field and examining the perianal area, vagina, and rectum, a circular incision is made around the fistula opening on the vaginal side. A cylindrical segment of the rectal wall containing the fistula tract is mobilized, splitting the tissue in the anastomotic defect area in all directions. Next, interrupted sutures with 2.0 Vicryl sutures on a 5 / 8 needle are placed longitudinally along the mobilized portion of the fistula tract. The ends of the sutures are passed through the lumen of the fistula tract and tied on the intestinal side. This "inverts" the infected portion of the tract into the lumen of the intestine or anal canal, leaving a clean wound surface without suture material on the vaginal side of the wound. A vaginal flap is then formed from the portion of the rectovaginal septum distal to the anastomotic area.Then, the vaginal flap is shifted in the proximal direction, closing the anastomosis zone and fixing the flap to the proximal and lateral edges of the wound in the transverse direction, avoiding excessive tension with separate interrupted sutures using 2.0 Vicryl thread.

[0011] Clinical Example 1

[0012] Patient M. complained of small, periodic discharges of intestinal contents through the rectum and vagina.

[0013] The patient's medical history revealed that she had previously undergone a laparoscopic low anterior rectal resection with lymphadenectomy and transverse colostomy for T2N0M0 mid-ampullary rectal cancer. Postoperatively, a complication was identified: small-colonic bowel obstruction caused by a transverse colostomy stricture and sigmoid-rectal anastomotic leak. Consequently, transanal suturing of the anastomotic defect and drainage of the presacral space were performed. Subsequently, the patient noted the above-mentioned complaints and underwent a comprehensive examination. A high-grade rectovaginal fistula originating from the colorectal anastomosis was diagnosed. A vaginal examination revealed a fistula opening up to 0.8 cm in diameter located 5 cm proximal to the vaginal vestibule along the posterior vaginal wall.A rectal examination revealed a funnel-shaped indentation up to 0.8 cm in diameter in the scars along the anterior wall of the lower ampulla of the rectum, 5 cm from the anus at the 12 o'clock position on a conventional clock face, at the level of the anastomosis. Proctography revealed an X-ray image of a sigmoid-rectal anastomosis failure with the formation of a rectovaginal fistula.

[0014] The patient underwent surgery using the proposed method. Postoperative pain did not exceed 5 points on the numerological assessment scale and was completely relieved by the third day after surgery. She was discharged from the hospital on the fifth day due to satisfactory condition and the absence of postoperative complications. Follow-up with a proctologist at her local hospital is recommended.

[0015] A postoperative examination was performed 3 months after surgery. Vaginal and rectal examinations revealed no evidence of a fistula opening. A proctography was performed, and no leakage of water-soluble contrast material beyond the intestinal wall was detected.

[0016] Clinical Example 2

[0017] Patient Z. presented with complaints of a vaginal-colic fistula and periodic vaginal discharge of small amounts of enema fluid. Due to a double-barreled ileostomy, she did not experience vaginal discharge of intestinal contents.

[0018] From the patient’s medical history, it is known about previously undergone surgical interventions:

[0019] - March 2023 - resection of the rectum, amputation of the uterus with appendages due to rectal cancer pT3N0M0;

[0020] - November 2023 - laparotomy, intra-abdominal closure of a single-barrel sigmoidostomy with the formation of an end-to-end sigmoidorectal anastomosis, resection of the ileum, formation of a preventive separate double-barrel ileostomy;

[0021] - June 2024 - laparotomy, dissociation of the colon-vaginal fistula with the formation of a descendoanal anastomosis.

[0022] Based on clinical and instrumental examination, the patient was diagnosed with a recurrent high-grade rectovaginal fistula originating from the colorectal anastomosis site. Grade 1 anal sphincter insufficiency was also present.

[0023] The patient underwent surgical treatment using the proposed method. The postoperative period was uneventful, and the vaginal wound healed by primary intention. Pain, according to the numerological assessment scale, did not exceed 2 points during hospitalization. On the sixth day after surgery, the patient was discharged in satisfactory condition under the supervision of a surgeon / proctologist at her place of residence.

[0024] The patient was observed for 4 months. At the time of the follow-up examination, she had no complaints. Bimanual digital examination of the rectovaginal septum did not reveal a fistula opening on the rectal and vaginal side. Transrectal and transvaginal ultrasound examinations were performed, which revealed fibrous changes at the site of the previously identified fistula. The fistula opening was absent, thus, no ultrasound data indicating fistula recurrence were found. The functional state of the occlusive apparatus of the rectum was assessed using sphincterometry before and after surgery. Before surgery, the mean anal canal pressure at rest (MACP) was 31 mmHg, and the maximum anal canal pressure during voluntary contraction (MACP) was 171 mmHg. Before the operation, a decrease in the average anal canal pressure at rest was detected compared to normal values ​​(41-63 mm Hg).Postoperatively, the following parameters were measured: BP (spondylosis) - 39 mmHg, BP (spondylosis) - 178 mmHg. The surgical procedure did not significantly affect the function of the rectal occlusion apparatus, as confirmed by sphincterometry data. The proctography, which showed no contrast agent leakage beyond the intestinal wall, allowed the patient to undergo reconstructive surgery.

[0025] The proposed method, in comparison with known methods of surgical treatment of rectovaginal fistulas from the area of ​​colorectal anastomosis, makes it possible to:

[0026] 1. increase the healing rate of rectovaginal fistulas;

[0027] 2. reduce the recurrence rate of rectovaginal fistulas;

[0028] 3. reduce the incidence of complications in the treatment of RBC from the colorectal anastomosis area;

[0029] 4. Indirectly improve the quality of life of patients after closure of the diverting stoma as a result of successful treatment of RVS.

[0030] Bibliography

[0031] 1. Watanabe J, Ota M, Kawaguchi D, et al. Incidence and risk factors for rectovaginal fistula after low anterior resection for rectal cancer. Int J Colorectal Dis. 2015 Dec;30(12):1659-66. doi: 10.1007 / s00384-015-2340-5

[0032] 2. Zheng H, Guo T, Wu Y, et al. Rectovaginal fistula after low anterior resection in Chinese patients with colorectal cancer. Oncotarget. 2017 Apr 11;8(42):73123-73132. doi: 10.18632 / oncotarget. 17046.

[0033] 3. Matthiessen P, Hansson L, Sjodahl R, et al. Anastomotic-vaginal fistula (AVF) after anterior resection of the rectum for cancer-occurrence and risk factors. Colorectal Dis. 2010 Apr; 12(4):351-7. doi: 10.1111 / j.l463-1318.2009.01798.x.

[0034] 4. Komori K, Kinoshita T, Oshiro T, et al. Surgical Strategy for Rectovaginal Fistula After Colorectal Anastomosis at a High-volume Cancer Center According to Image Type and Colonoscopy Findings. Anticancer Res. 2019 Sep;39(9):5097-5103. doi: 10.21873 / anticanres. 13704.

[0035] 5. Woo IT, Park JS, Choi GS, et al. Optimal strategies of rectovaginal fistula after rectal cancer surgery. Ann Surg Treat Res. 2019 Sep;97(3):142-148. doi: 10.4174 / astr.2019.97.3.142.

[0036] 6. Lohsiriwat V, Jitmungngan R. Rectovaginal fistula after low anterior resection: Prevention and management. World J Gastrointest Surg. 2021 Aug 27;13(8):764-771. doi: 10.4240 / wjgs.vl3.i8.764.

[0037] 7. Mudrov, A.A. Rectovaginal fistulas: dissertation... Doctor of Medical Sciences: 3.1.9. / Mudrov Andrey Anatolyevich; [Place of protection: Federal State Budgetary Institution "National Medical Research Center of Proctology named after A.N. Ryzhikh" of the Ministry of Health of the Russian Federation]. - Moscow, 2023. - 229 p.

[0038] 8. Lamazza A, Fiori E, Schillaci A, et al. Treatment of rectovaginal fistula after colorectal resection with endoscopic stenting: long-term results. Colorectal Dis. 2015 Apr;17(4):356-60. doi: 10.11ll / codi.12876.

[0039] 9. Drefs M, Schomer Cuenca S, Wirth U, et al. Predictors of outcome for treatment of enterovaginal fistula: Therapeutic strategies for treatment. Int J Colorectal Dis. 2023 Jul 7;38(1):187. doi:10.1007 / s00384-023-04453-2.

[0040] 10. Corte H, Maggiori L, Treton X, et al. Rectovaginal Fistula: What Is the Optimal Strategy?: An Analysis of 79 Patients Undergoing 286 Procedures. Ann Surg. 2015 Nov;262(5):855-60; discussion 860-1. doi: 10.1097 / SLA.0000000000001461.

[0041] 11. Patent No. 2739133 CI Russian Federation, IPC A61B 17 / 42, Combined method for surgical treatment of rectovaginal fistulas in combination with anal sphincter insufficiency by evagination of the anterior wall of the rectum with a fistula opening, anterior sphincter levatorplasty: declared 04.06.2020: published 21.12.2020 / Yu. A. Shelygin, A. Yu. Titov, A. A. Mudrov et al.

[0042] 12. Serebry A.B., Titov A.Yu., Kostarev I.V., et al. Results of surgical treatment of rectovaginal fistulas by the evagination method. Coloproctology. - 2024. - No. 3 (23). - P. 59-68.

Claims

A method for the combined surgical treatment of rectovaginal fistulas in the area of ​​a colorectal anastomosis, characterized by the fact that the anastomotic area bearing the defect is "screwed" into the intestinal lumen, sutures previously formed on the side of the vaginal wound are tied from the side of the intestinal lumen and the evagination area is covered with a vaginal flap in the proximal direction, characterized in that after a circular incision around the anastomotic defect, a cylindrical segment of the rectal wall with a fistula tract is mobilized, splitting it in the anastomotic area in all directions, then separate interrupted sutures with Vicryl 2 thread are applied to the mobilized part of the fistula tract in the longitudinal direction.0 on a 5 / 8 needle, the ends of the threads are passed through the lumen of the fistula tract and tied from the side of the intestinal lumen, thus “screwing” the infected part of the tract into the lumen of the intestine or anal canal, then a vaginal flap is formed from the part of the rectovaginal septum distal to the anastomosis zone, then the vaginal flap is shifted in the proximal direction, closing the anastomosis zone, the flap is fixed to the proximal and lateral edges of the wound in the transverse direction without tension with separate interrupted sutures using a 2.0 Vicryl thread.

Citation Information

Patent Citations

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