Dataset Information

Fistulotomy with or without marsupialisation of wound edges in treatment of simple anal fistula: a randomised controlled trial.

ABSTRACT:

Background

Promotion of healing of the anal wound after fistulotomy may help accelerate recovery and return to work. The present study aimed to assess the effect of marsupialisation of the edges of the laid open fistula track on wound healing after anal fistulotomy for simple anal fistula.

Methods

This was a prospective randomised trial on patients with simple anal fistula. Patients were randomly assigned to one of two groups; group I underwent anal fistulotomy and group II underwent anal fistulotomy and marsupialisation of the edges of the laid open track. Outcomes of the study were time to achieve complete wound healing, operation time, postoperative pain and complications.

Results

Sixty patients of mean age of 40.8 years with simple anal fistula were randomly divided into two equal groups. No significant differences between the two groups regarding operation time (16.8 vs 18.4 minutes; P = 0.054), postoperative pain score (1.6 vs 1.2; P = 0.22), and complication rates were recorded. Group II achieved complete healing in a significantly shorter duration than group I (5.1 vs 6.7 weeks; P < 0.0001).

Conclusion

Marsupialisation of the edges of the laid open fistula track after fistulotomy resulted in quicker wound healing with similar complication and recurrence rates to lay open fistulotomy alone.

SUBMITTER: Anan M

PROVIDER: S-EPMC6667946 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

Fistulotomy with or without marsupialisation of wound edges in treatment of simple anal fistula: a randomised controlled trial.

Anan M M Emile S H SH Elgendy H H Shalaby M M Elshobaky A A Abdel-Razik M A MA Elbaz S A SA Farid M M

Annals of the Royal College of Surgeons of England 20190603 7

<h4>Background</h4>Promotion of healing of the anal wound after fistulotomy may help accelerate recovery and return to work. The present study aimed to assess the effect of marsupialisation of the edges of the laid open fistula track on wound healing after anal fistulotomy for simple anal fistula.<h4>Methods</h4>This was a prospective randomised trial on patients with simple anal fistula. Patients were randomly assigned to one of two groups; group I underwent anal fistulotomy and group II underw ...[more]

PMID: 31155896

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Project description:BackgroundAnal fistula surgery often leads to postoperative pain, which can hinder recovery and negatively impact patients' quality of life. This prospective, randomised, controlled trial (RCT) aims to investigate the efficacy of acupuncture in alleviating postoperative pain and reducing the usage of analgesic medications following anal fistula surgery.MethodsThis single-centre, patient-blinded, assessor-blinded, placebo-controlled randomised controlled trial (RCT) will be conducted at a tertiary referral hospital. A total of 66 patients with low simple anal fistula will be randomised at a 1:1 ratio to receive either acupuncture or sham acupuncture. The primary outcome is the difference in the numerical rating scale (NRS) pain score before and after acupuncture at 6 hours post surgery. The secondary outcomes include postoperative analgesic usage (Day 0 to Day 7), complications (including infection, urinary retention, and bleeding from Day 0 to Day 7, as well as delayed wound healing and recurrence within 3 months post surgery), sleep quality (PSQI from Day 0 to Day 7), psychological state (SDS and SAS on Day 0, Day 1, and Day 7), and overall recovery quality (QoR-15 on Day 1, Day 3, and Day 7). The statistical analysis of this trial will be conducted using SPSS software, validating the normality of data and the homogeneity of variance, and employing t-tests, Mann-Whitney U tests, chi-square tests, and repeated measures ANOVA to analyze baseline data, primary and secondary outcome indicators.DiscussionThis study aims to contribute to the expanding evidence base regarding the role of acupuncture in postoperative pain management. Through a comprehensive assessment of pain relief, analgesic usage, and other recovery-related outcomes, our findings will establish a foundation for standardizing acupuncture protocols specifically tailored for anal fistula surgery patients. The strengths of this trial are rooted in its rigorous randomised controlled trial (RCT) design, comprehensive outcome measures, and focused examination of a clinically significant issue. Ultimately, the findings of this trial have the potential to offer valuable insights into the utility of acupuncture as an adjunctive therapy for postoperative pain management among anal fistula patients, thereby informing future clinical practice and research directions.Trial registrationThis study was registered in the China Clinical Trial Registry on June 1, 2024, with registration number: ChiCTR2400085178.

Project description:Introduction: Anal fistula is one of the commonest ailments seen by anorectal surgeons as surgery is currently the preferred treatment for it. Diabetes mellitus is a risk factor that can lead to slow wound healing after anal fistula surgery. Because of the large postoperative wound surface of anal fistula, patients with diabetes can have an increased probability of wound infection, which makes it hard to heal. There is an extensive clinical experience for wound healing in traditional Chinese medicine (TCM). The Jiedu Shengji decoction (JSD) is a widely used external washing decoction in clinical practice. However, the current evidence on it is still insufficient. Therefore, we report this carefully designed clinical trial to assess the efficacy and safety of JSD in the treatment of postoperative wounds in diabetic patients with anal fistula. Methods and analysis: This study was designed to be a randomized, double-blind, placebo-controlled, multi-center clinical trial. There were 60 eligible participants who were randomized at a 1:1 ratio to the intervention and placebo groups. Both groups received the same standard treatment. The intervention group was given external washing decoction of TCM (JSD), while the placebo group was given the placebo made of excipients and flavoring agents. The main outcome measures include wound healing, distribution of wound pathogens, levels of inflammatory mediators, and blood glucose. The secondary outcome measures included lipids, the quality of the life evaluation scale (Short-Form Health Survey 36). Assessments were performed before the start of the study, at 1st, 2nd, 3rd, and 4th weeks after the intervention, and at 8th, 12th, and 16th follow-up weeks. Discussion: The clinical study we proposed will be the first randomized, double-blind, placebo-controlled, multi-center clinical trial study to assess the efficacy and safety of TCM external washing (JSD) in the treatment of postoperative wounds in diabetic patients with anal fistula. Ethics and dissemination: The Medical Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine has reviewed this study protocol and gave its approval and consent on 17 March, 2022 (Ethical Review Number: 2022KL-018).

Dataset Information

Fistulotomy with or without marsupialisation of wound edges in treatment of simple anal fistula: a randomised controlled trial.

Background

Methods

Results

Conclusion

Publications

Fistulotomy with or without marsupialisation of wound edges in treatment of simple anal fistula: a randomised controlled trial.

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