Bowel Preparation in Minimally Invasive Gynecologic Surgery

NCT06820359 | Recruiting

• 1 other identifier: 17828
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

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.

Conditions

Gynecologic Disease

Keywords

gynecologic surgery; bowel preparation; patient satisfaction; ease of surgery

Outcome Measures

Primary Outcomes (7)

• 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.

  Immediately following surgery

• 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.

  From discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery

• 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.

  Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery

• 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.

  Between discharge from the hospital for the surgery and 12 weeks post-discharge from the hospital for the surgery

• Patient satisfaction prior to surgery

  Patient satisfaction in both groups with the surgical prep will be done using a patient questionnaire. The questionnaire consists of one satisfaction questionnaire with a Likert-type scale response that includes the categories Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree.

  Day of surgery, prior to surgery

• Patient level of pain prior to surgery

  Patients in both groups will report their level of pain prior to surgery by placing a mark on a 10 cm. visual analogue scale that ranges from no pain to worst pain.

  Day of surgery before surgery.

• Patient post-surgery evaluation

  Patients will evaluate surgical preparation and symptoms using a questionnaire. Satisfaction will be rated using a five-point Likert-type scale ranging from Strongly Agree to Strongly Disagree. Patients will also rate current symptoms on a scale of five-point scale of zero to four with zero being no symptoms and 4 being distressing symptoms.

  Post surgical day one

Study Arms (2)

Bowel Preparation

EXPERIMENTAL

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

Other: Bowel Preparation

No bowel preparation

PLACEBO COMPARATOR

Subjects will not do a bowel preparation.

Other: No bowel preparation

Interventions

Bowel Preparation OTHER

Individuals will perform a bowel preparation using a Fleet saline enema.

Also known as: enema

Bowel Preparation

No bowel preparation OTHER

Subjects will not be required to perform bowel preparation before surgery.

No bowel preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aslam: lead

Study Sites (2)

Henry Ford St. John Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Henry Ford Macomb-Oakland Hospital, Warren Campus

Warren, Michigan, 48093, United States

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female; Patient Satisfaction

Interventions

Cathartics; Enema

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Drug Therapy; Therapeutics

Study Officials

• Muhammad Aslam, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Aslam, MD

CONTACT

313-343-3494; maslam2@hfhs.org

Nathan Wagstaff, MD

CONTACT

313-343-7798; nwagsta1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will be blind to study group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Gyn-Uro, Henry Ford St. John Hospital

Model Details: Patients will be randomized 1:1 to either perform bowel preparation prior to surgery or no bowel preparation.

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 11, 2025
• Study Start: February 17, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)