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Cutting seton versus decompression and drainage seton in the treatment of high complex anal fistula: a randomized controlled trial.

ABSTRACT: This study aimed to compare the efficacy between decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula. Patients were randomly assigned 1:1 to DADS or CS group. The primary outcome was the rate of wound healing. Second outcomes included time taken to return to work, postoperative pain, the severity of fecal incontinence and other complications. A total of 120 patients with a mean age of 39 years were included. There was no significant difference in the rate of complete wound healing at 1 year. The mean time taken to return to work was 5 ± 2 days in DADS group, shorter than CS group (10 ± 3, p < 0.001). Mean vaizey incontinence score and the post-operation pain in DADS group was significantly lower than CS group. No significant difference was found between two groups in the incidence of complications. DADS is as effective as Cutting seton for the treatment of high complex anal fistula but is associated with less postoperative pain and better sphincter function preserving.

SUBMITTER: Yu Q

PROVIDER: S-EPMC9098520 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Cutting seton versus decompression and drainage seton in the treatment of high complex anal fistula: a randomized controlled trial.

Yu Qiuxiang Q Zhi Congcong C Jia Lansi L Li Hui H

Scientific reports 20220512 1

This study aimed to compare the efficacy between decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula. Patients were randomly assigned 1:1 to DADS or CS group. The primary outcome was the rate of wound healing. Second outcomes included time taken to return to work, postoperative pain, the severity of fecal incontinence and other complications. A total of 120 patients with a mean age of 39 years were included. There was no significant differ ...[more]

PMID: 35551237

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Project description:BackgroundThe placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head resection was non-inferior to intra-abdominal drainage in terms of postoperative reinterventions and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. The aim of the present PANDRA II trial is to evaluate the clinical outcome with versus without prophylactic drain placement after distal pancreatectomy.MethodsThe PANDRA II trial is a mono-center, randomized controlled, non-inferiority trial with two parallel study groups. In the control group at least one passive intra-abdominal drain is placed at the pancreatic resection margin. In the experimental group no drains are placed. The primary endpoint of this trial will be the Comprehensive Complication Index (CCI) measuring all postoperative complications within 90 days. Secondary endpoints are in-hospital mortality and morbidity, including the rates of postoperative pancreatic fistula, chyle leak, postpancreatectomy hemorrhage, delayed gastric emptying, reinterventions and reoperations, surgical site infection, and abdominal fascia dehiscence. Moreover, length of hospital stay, duration of intensive care unit stay, and the rate of readmission after discharge from hospital (up to day 90 after surgery) are assessed. We will need to analyze 252 patients to test the hypothesis that no drainage is non-inferior to drain placement in terms of the CCI (δ 7.5 points) in a one-sided t test with a one-sided level of significance of 2.5% and a power of 80%.DiscussionThe results of the PANDRA II trial will help to evaluate the effect of an omission of prophylactic intraperitoneal drainage on the rate of complications after open or minimally invasive distal pancreatectomy.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00013763 . Registered on 6 March 2018.

Project description:BackgroundHigh perianal abscess is an emergency in the anorectal department. It can result in long-term pain and a huge psychological burden to patients, and seriously affects the quality of life of patients. At present, the effect of antibiotics alone for high perianal abscess is not satisfactory. Loose combined cutting seton (LCCS) can effectively treat high anal fistulas and high perianal abscesses in our clinical practice, but there is no sufficient evidence for its effectiveness in the treatment of high perianal abscesses. The purpose of this study is to observe the effectiveness and safety of LCCS in the treatment of high perianal abscess.MethodsThis study is a single-center, prospective, single-blind, randomized, controlled, non-inferiority clinical study. This study will include patients who are diagnosed with high perianal abscesses and hospitalized for surgery in the Department of Proctology in China-Japan Friendship Hospital (enrollment time: from January 2022 through December 2024). Patients in the experimental group will be treated with LCCS, while patients in the control group will be treated with incision and drainage. Follow-ups will be performed at 1, 3, 7, 14, 21, 28, 90, and 180 days after the operation. The main outcome measures are as follows: (I) cure rate; (II) half-year recurrence rate; (III) postoperative pain visual analog scale (VAS) score; (IV) wound healing time; (V) postoperative anal function evaluation by the Wexner scale; (VI) pressure measurement of the anal canal and rectum before and at half a year after surgery; and (VII) the incidence of adverse events.DiscussionThis study will assess the effectiveness and safety of LCCS in the treatment of high perianal abscess through a strictly designed randomized controlled study, and provides evidence for treatment in clinical practice, thereby improving the treatment effect and improving patients' quality of life.Trial registrationChinese Clinical Trial Registry ChiCTR2100049198.

Dataset Information

Cutting seton versus decompression and drainage seton in the treatment of high complex anal fistula: a randomized controlled trial.

Publications

Cutting seton versus decompression and drainage seton in the treatment of high complex anal fistula: a randomized controlled trial.

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