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NCT Number: NCT06820359

Bowel Preparation in Minimally Invasive Gynecologic Surgery

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.

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Key information

Conditions

Gynecologic Disease Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Health Behavior Patient Satisfaction Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford St. John Hospital, Detroit, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bowel preparation

Other

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

Other names: enema

No bowel preparation

Other

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

Primary outcomes

  1. Physician reported ease of surgery

    Time frame: Immediately following 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.

  2. Number of patients with a hospital readmission between discharge and 12 weeks post-discharge.

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

    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.

  3. 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

    Time frame: 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.

  4. Number of surgical site infections between discharge and 12 weeks post-discharge.

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

    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.

  5. Patient satisfaction prior to surgery

    Time frame: Day of surgery, 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.

  6. Patient level of pain prior to surgery

    Time frame: Day of surgery before 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.

  7. Patient post-surgery evaluation

    Time frame: Post surgical day one

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Aslam, MD

CONTACT

[email protected]

313-343-3494

Nathan Wagstaff, MD

CONTACT

[email protected]

313-343-7798

Sponsors and collaborators

Lead sponsor

Muhammad Aslam

Other

Registry information

Official study title

Investigating the Necessity of Bowel Preparation in Minimally Invasive Gynecologic Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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