Bowel Preparation in Minimally Invasive Gynecologic Surgery

Muhammad Aslam

Status: Enrolling

Conditions: Gynecologic Disease

Treatments: Other: Bowel Preparation; Other: No bowel preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT06820359

17828

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups, including a placebo group

Bowel Preparation

Experimental group

Description:

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

Treatment:

Other: Bowel Preparation

No bowel preparation

Placebo Comparator group

Description:

Subjects will not do a bowel preparation.

Treatment:

Other: No bowel preparation