Bowel Preparation in Minimally Invasive Gynecologic Surgery

Investigating the Necessity of Bowel Preparation in Minimally Invasive Gynecologic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Disease
• Intervention / Treatment: Other: Bowel Preparation; Other: No bowel preparation

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.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Aslam, MD; Phone Number: 313-343-3494; Email: maslam2@hfhs.org
• Study Contact Backup: Name: Nathan Wagstaff, MD; Phone Number: 313-343-7798; Email: nwagsta1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford St. John Hospital
      • Contact: Nathan Wagstaff, MD; Phone Number: 313-343-7798; Email: nwagsta1@hfhs.org
      • Contact: Muhammad Aslam, MD; Phone Number: 313-343-3498; Email: maslam2@hfhs.org
    • Warren, Michigan, United States, 48093
      • Recruiting
      • Henry Ford Macomb-Oakland Hospital, Warren Campus
      • Contact: Muhammad Aslam, MD
      • Contact: Muhammad Aslam, MD; Phone Number: 313-343-3494; Email: maslam2@hfhs.org
      • Contact: Nathan Wagstaff, MD; Phone Number: 313-343-7798; Email: nwagsta1@hfhs.org
      • Contact: Audrey Lunde, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bowel Preparation; Subjects will perform bowel preparation using a Fleet saline enema one day before the scheduled procedure.	Other: Bowel Preparation; Individuals will perform a bowel preparation using a Fleet saline enema.; Other Names: enema
Placebo Comparator: No bowel preparation; Subjects will not do a bowel preparation.	Other: No bowel preparation; Subjects will not be required to perform bowel preparation before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician reported ease of surgery	The investigator will complete a survey following each surgery about the ease of surgery. "Surgical field quality" will be scored as Outstanding, Good, Fair, or Poor. "Adequate visualization" is a yes/no response. "Difficulty in handling the bowel" is a yes/no response. There is room for free text.	Immediately following surgery
Number of patients with a hospital readmission between discharge and 12 weeks post-discharge.	The number of patients with a hospital readmission between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery will be collected via chart review.	From discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
Number of patients with a urinary tract infection between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery	The number of patients who experience a urinary tract infection between discharge from the hospital for the surgery and 12 weeks post-discharge will be collected via chart review.	Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
Number of surgical site infections between discharge and 12 weeks post-discharge.	The number of patients with surgical site infections between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery will be collected via chart review.	Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
Patient satisfaction prior to surgery	Patient satisfaction in both groups with the surgical prep will be done using a patient questionnaire. The questionnaire consists of one satisfaction questionnaire with a Likert-type scale response that includes the categories Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree.	Day of surgery, prior to surgery
Patient level of pain prior to surgery	Patients in both groups will report their level of pain prior to surgery by placing a mark on a 10 cm. visual analogue scale that ranges from no pain to worst pain.	Day of surgery before surgery.
Patient post-surgery evaluation	Patients will evaluate surgical preparation and symptoms using a questionnaire. Satisfaction will be rated using a five-point Likert-type scale ranging from Strongly Agree to Strongly Disagree. Patients will also rate current symptoms on a scale of five-point scale of zero to four with zero being no symptoms and 4 being distressing symptoms.	Post surgical day one

Collaborators and Investigators

• Sponsor: Muhammad Aslam
• Investigators: Principal Investigator: Muhammad Aslam, MD, Henry Ford Health

Study record dates

Study Major Dates

• Study Start (Estimated): February 17, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: gynecologic surgery; bowel preparation; patient satisfaction; ease of surgery
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female
• Other Study ID Numbers: 17828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Very small, local study. Data may not be representative.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No