Bowel Preparation in Minimally Invasive Gynecologic Surgery

Last updated: February 8, 2025
Sponsor: Muhammad Aslam
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

No bowel preparation

Bowel Preparation

Clinical Study ID

NCT06820359
17828
  • Ages > 18
  • Female

Study Summary

This is a prospective randomized study of patients who are scheduled to undergo minimally invasive robotic gynecologic surgery. Patients will be randomized to require either pre-surgical bowel preparation vs. no bowel preparation. The effect of bowel preparation on intraoperative visualization, bowel handling, intestinal load and ease of surgery will be assessed. Patient comfort and satisfaction will be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Scheduled to undergo minimally invasive robotic gynecologic surgery;

  • Age 18 years and above

  • Willing to perform an enema if randomized to the enema group

  • Able to read and understand English

  • Willing to sign an informed consent form

Exclusion

Exclusion Criteria:

  • Scheduled for open surgery

  • Younger than 18 years of age

  • Unwilling to perform an enema if randomized to the enema group

  • Unable to read and understand English

  • Unwilling to sign an informed consent form

Study Design

Total Participants: 166
Treatment Group(s): 2
Primary Treatment: No bowel preparation
Phase:
Study Start date:
February 17, 2025
Estimated Completion Date:
January 31, 2026

Study Description

Bowel preparation prior to gynecologic surgery is a common practice based more on assumptions than evidence. Expert opinion rules over evidence regarding its utility and necessity. The objective of this study is to determine if there is an association between the use of bowel preparation in minimally invasive gynecologic surgery and the ease of the surgery. This is a randomized controlled trial of adult patients of Dr. Muhammad Aslam who are scheduled to undergo minimally invasive robotic gynecologic surgery at Henry Ford St. John Hospital and Henry Ford Macomb-Oakland Hospital-Warren Campus. Patients will be randomly assigned to receive or not receive instructions to perform bowel preparation one day prior to surgery using an over-the-counter Fleet® saline enema. Data to be collected include demographics, body mass index (BMI), parity, and surgical history. Data collection from patients will be performed on postoperative day one prior to discharge from the hospital. Data collection will include patient satisfaction with having to use or not using bowel preparation for surgery and pain control. Dr. Aslam will complete a survey following each surgery about intraoperative visualization, bowel handling, intestinal load, and the overall ease of surgery. According to the power analysis, at least 75 subjects will be needed in each group, for a total of 150. To account for attrition, the sample size will be inflated by 10% plus an additional one subject, to maintain an even number of subjects (166 subjects). Three hundred patients may need to be initially screened to obtain 166. Univariable analysis of factors associated with the bowel preparation group will be assessed using Student's t-test and chi-squared analysis. Multivariable analysis of acceptable bowel preparation will be done using logistic regression.

Connect with a study center

  • Henry Ford St. John Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Macomb-Oakland Hospital, Warren Campus

    Warren, Michigan 48093
    United States

    Active - Recruiting

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