Bowel Preparation in Minimally Invasive Gynecologic Surgery

NCT ID: NCT06820359

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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.

Conditions

Gynecologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Bowel Preparation

Subjects will perform bowel preparation using a Fleet saline enema one day before the scheduled procedure.

Group Type: EXPERIMENTAL

Bowel Preparation

Intervention Type: OTHER

Individuals will perform a bowel preparation using a Fleet saline enema.

No bowel preparation

Subjects will not do a bowel preparation.

Group Type: PLACEBO_COMPARATOR

No bowel preparation

Intervention Type: OTHER

Subjects will not be required to perform bowel preparation before surgery.

Interventions

Bowel Preparation

Individuals will perform a bowel preparation using a Fleet saline enema.

Intervention Type: OTHER

No bowel preparation

Subjects will not be required to perform bowel preparation before surgery.

Intervention Type: OTHER

Other Intervention Names

enema

Eligibility Criteria

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Muhammad Aslam

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aslam

Chief Gyn-Uro, Henry Ford St. John Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Muhammad Aslam, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health

Locations

Henry Ford St. John Hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Henry Ford Macomb-Oakland Hospital, Warren Campus

Warren, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Muhammad Aslam, MD

Role: CONTACT

maslam2@hfhs.org

313-343-3494

Nathan Wagstaff, MD

Role: CONTACT

nwagsta1@hfhs.org

313-343-7798

Facility Contacts

Muhammad Aslam, MD

Role: primary

maslam2@hfhs.org

313-343-3498

Nathan Wagstaff, MD

Role: backup

nwagsta1@hfhs.org

313-343-7798

Muhammad Aslam, MD

Role: primary

maslam2@hfhs.org

313-343-3494

Nathan Wagstaff, MD

Role: backup

nwagsta1@hfhs.org

313-343-7798

Muhammad Aslam, MD

Role: backup

Audrey Lunde, MD

Role: backup

Other Identifiers

17828

Identifier Type: -

Identifier Source: org_study_id