Actively Recruiting
Investigating the Necessity of Bowel Preparation in Minimally Invasive Gynecologic Surgery
Led by Muhammad Aslam · Updated on 2025-02-11
166
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients scheduled for minimally invasive robotic gynecologic surgery to understand if doing bowel preparation before surgery affects how easy the surgery is. This study explores whether bowel preparation improves visibility during surgery, bowel handling, and intestinal load, as well as how comfortable and satisfied patients feel about the process. It is a randomized controlled trial led by Dr. Muhammad Aslam to provide evidence on the necessity of bowel preparation in this type of surgery. Participants will be randomly assigned to one of two groups: one group will perform bowel preparation using a Fleet saline enema one day before surgery, while the other group will not do any bowel preparation. This setup allows comparison between patients who prepare their bowels and those who do not. The study will collect various data including demographics and surgical history, and surgeons will complete surveys after each operation regarding the ease of surgery and other factors. During the study, data will be gathered from patients on the day of surgery and the day after surgery before hospital discharge, including their satisfaction and pain levels. Surgeons will report on intraoperative details immediately after surgery. Participants will be monitored for complications like infections or readmissions up to 12 weeks after surgery. The total duration of participation covers the pre-surgical preparation, surgery day, postoperative evaluation, and follow-up period to ensure comprehensive assessment of outcomes.
CONDITIONS
Brief Title
Bowel Preparation in Minimally Invasive Gynecologic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day prior to surgery
Participants are randomly assigned to either perform a bowel preparation using a Fleet saline enema one day before surgery or to not perform bowel preparation prior to minimally invasive robotic gynecologic surgery.
1 visit on the day of surgery (in-person)
Duration - Up to 12 weeks post-discharge
After surgery, participants are monitored for surgical outcomes including readmissions, infections, and patient satisfaction and pain assessments up to 12 weeks post-discharge.
1 visit on post-surgical day one prior to discharge; additional follow-up as needed up to 12 weeks
Trial Site Locations
Total: 2 locations
1
Henry Ford St. John Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Henry Ford Macomb-Oakland Hospital, Warren Campus
Warren, Michigan, United States, 48093
Actively Recruiting
Research Team
M
Muhammad Aslam, MD
N
Nathan Wagstaff, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here