Bowel Preparation in Minimally Invasive Gynecologic Surgery
ConditionGynecologic Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMuhammad Aslam
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bowel Preparation
Other interventionIndividuals will perform a bowel preparation using a Fleet saline enema.
No bowel preparation
Other interventionSubjects will not be required to perform bowel preparation before surgery.
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Bowel PreparationExperimental treatment 1 intervention
Group B: No bowel preparationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately following surgery2
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.
Time frame
From discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery3
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.
Time frame
Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery4
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.
Time frame
Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Muhammad Aslam
Lead sponsor
Henry Ford Health System
Sponsor institution
Source ClinicalTrials.gov