Bowel Preparation in Minimally Invasive Gynecologic Surgery

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Muhammad Aslam
Study ID
NCT06820359
Status
Recruiting

Conditions

  • Gynecologic Disease

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bowel Preparation — OTHER
    Individuals will perform a bowel preparation using a Fleet saline enema.
  • No bowel preparation — OTHER
    Subjects will not be required to perform bowel preparation before surgery.

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
Feb 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Bowel Preparation
    Subjects will perform bowel preparation using a Fleet saline enema one day before the scheduled procedure.
  • Placebo Comparator: No bowel preparation
    Subjects will not do a bowel preparation.

Primary Outcome Measure

Physician reported ease of surgery [ Time Frame: Immediately following surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Henry Ford St. John HospitalDetroitMichigan48202
Muhammad Aslam, MD
313-343-3498
Nathan Wagstaff, MD
313-343-7798
Henry Ford Macomb-Oakland Hospital, Warren CampusWarrenMichigan48093
Muhammad Aslam, MD
313-343-3494
Nathan Wagstaff, MD
313-343-7798
Muhammad Aslam, MD
Audrey Lunde, MD

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