Comparison Study of the Effect of Enema in Anal Surgery

The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Fistula; Hemorrhoids
• Intervention / Treatment: Procedure: enema; Procedure: no enema

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 Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 235
    • Taipei Medical University Shuang-Ho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group: enema; receiving enema at the night before anal surgery	Procedure: enema; receiving enema at the night before anal surgery
Active Comparator: Control Group: no enema; no enema before anal surgery	Procedure: no enema; no enema before anal surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Study Director: Tung Cheng Chang, MD, PHD, Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): September 10, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: October 29, 2022
• First Submitted That Met QC Criteria: October 29, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Fistula; Hemorrhoids
• Other Study ID Numbers: N202209016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used in this study can be obtained from the investigator upon reasonable request.
• IPD Sharing Time Frame: data is available as the study is complete and for 12 month period
• IPD Sharing Access Criteria: will be shared upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No