The Prevention of Rectovaginal Fistula After Rectal Cancer Surgery by Packing With Laparoscopic Dislocated Fat Flap Containing Ovarian Vascular Pedicle Anterior to the Anastomotic Stoma

Abstract Background: Rectovaginal fistula (RVF) is an abnormal channel formed by epithelial tissue between the anterior wall of rectum and the posterior wall of vagina, which is manifested as vaginal gassing and defecation. It is one of the common complications of female pelvic surgeries. With the increase of proctectomy for rectal cancer, the number of postoperative rectovaginal fistulas also increases. Once RVF occurs, although there are various treatments available, the failure rate is high [1]. RVF causes great suffer to women and is still a major problem in practice. Therefore, it is significant for female rectal cancer patients to prevent RVF after rectal cancer surgery and reduce its incidence. In this study, we introduce a new approach to prevent RVF during rectal cancer radical operation.Methods: In this two-arm randomized controlled trial, all operations were performed according to the principle of TME radical resection in rectal cancer surgery. Experimental group:The anterior rectal wall of about 1 cm distal to the anastomosis was dislocated. Before the anastomosis of the rectal end, a fat flap (usually left side) containing ovarian vascular pedicle was dislocated, measured by 10-15 cm in length and 2 cm in width. The fat flap containing ovarian vascular pedicle was packed and fixed anterior to the anastomotic stoma with fibrin glue.Control group :All operations were performed according to the principle of TME radical resection in rectal cancer surgery. Participants will be compared on several variables, including Incidence of rectovaginal fistula after operation(primary outcomes),the occurrence time of postoperative rectovaginal fistula,the occurrence time of rectovaginal fistula after stoma closure and other postoperative complications, such as anastomotic leakage, chylous leakage, intestinal obstruction, etc(secondary outcomes).Data collection will take place baseline , within one weeks post treatment and at 14-month follow-up .Determine that whether there was a statistical difference in the incidence of rectovaginal leakage between the experimental group and the control group.Discuss the feasibility of this method for the prevention of postoperative rectovaginal fistula.Discussion: It is easy and effective to prevent RVF after rectal cancer surgery by packing with laparoscopic dislocated fat flap containing ovarian vascular pedicle anterior to the anastomotic stoma.Trial registration: Chinese Clinical Trial Registry(ChiCTR)Rregistration ID: ChiCTR20003144.Registered on June 26, 2019.