Clinical trial NCT06820359: Bowel Preparation in Minimally Invasive Gynecologic Surgery
Official title: Investigating the Necessity of Bowel Preparation in Minimally Invasive Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Disease
Keywords: gynecologic surgery
bowel preparation
patient satisfaction
ease of surgery
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to either perform bowel preparation prior to surgery or no bowel preparation.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Physician reported ease of surgery
timeFrame: Immediately following surgery
measure: Number of patients with a hospital readmission between discharge and 12 weeks post-discharge.
timeFrame: From discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
measure: 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
timeFrame: Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
measure: Number of surgical site infections between discharge and 12 weeks post-discharge.
timeFrame: Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery
measure: Patient satisfaction prior to surgery
timeFrame: Day of surgery, prior to surgery
measure: Patient level of pain prior to surgery
timeFrame: Day of surgery before surgery.
measure: Patient post-surgery evaluation
timeFrame: Post surgical day one
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford St. John Hospital
state: Michigan
city: Warren
country: United States
facility: Henry Ford Macomb-Oakland Hospital, Warren Campus
state: Michigan
Study officials:
affiliation: Henry Ford Health
name: Muhammad Aslam, MD
role: PRINCIPAL_INVESTIGATOR
References: