Comparison Study of the Effect of Enema in Anal Surgery

Not Applicable

Completed

• Conditions: Hemorrhoids; Fistula
• Interventions: Procedure: no enema; Procedure: enema

• Registration Number: NCT05602987
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

Detailed Description

For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.

Study Timeline

• Study First Submitted: 2022-10-29
• Study First Submitted QC: 2022-10-29
• Study First Posted: 2022-11-02
• Study Start: 2022-11-14
• Primary Completion: 2023-09-10
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
• Patients who underwent fistulotomy or fistulectomy

Exclusion Criteria

• Emergency surgery
• Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery
• Complicated fistulectomy, e.g., requiring surgical drainage and seton placement
• Other types of anal surgery, e.g., anal fissure and colorectal cancer
• Liver cirrhosis
• Coagulation dysfunction
• Bedridden
• Human immunodeficiency virus infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group: no enema	no enema	no enema before anal surgery
Study Group: enema	enema	receiving enema at the night before anal surgery

Primary Outcome Measures

Name	Time	Method
Pain score	On postoperative day 0 to day 7	record max pain score(visual analog scale:0-10) each day
Consumption of analgesics	On postoperative day 0 to day 7	daily consumption of oral analgesics from post-operative day 0 to day 7

Secondary Outcome Measures

Name	Time	Method
First defecation after surgery	On postoperative day 0 to day 7	Time between first defecation and operation
Incidence of surgical site infection	On postoperative day 0-30	Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Incidence of Urinary retention	On postoperative day 0 to day 7	patients requiring foley catheterization during hospital stay

Trial Locations

Locations (1)

Taipei Medical University Shuang-Ho Hospital; 🇨🇳 New Taipei City, Taiwan