Gynecologic DiseaseNCT06820359
Bowel Preparation in Minimally Invasive Gynecologic Surgery
A study testing Bowel Preparation and No bowel preparation in people with Gynecologic Disease, run by Henry Ford Health System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Bowel Preparation and No bowel preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford St. John Hospital
Detroit, Michigan, 48202
Henry Ford Macomb-Oakland Hospital, Warren Campus
Warren, Michigan, 48093
About this study
Official title: Investigating the Necessity of 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.
Read the detailed description
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.
- Conditions
- Gynecologic Disease
- Being tested
- Bowel Preparation, No bowel preparation
- Keywords
- gynecologic surgery, bowel preparation, patient satisfaction, ease of surgery
- Medical subject headings
- Genital Diseases, Female, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel PreparationOther
Also called enema
Individuals will perform a bowel preparation using a Fleet saline enema.
No bowel preparationOther
Subjects will not be required to perform bowel preparation before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bowel Preparation | Experimental | Subjects will perform bowel preparation using a Fleet saline enema one day before the scheduled procedure. Receives: Other: Bowel Preparation |
| No bowel preparation | Placebo comparator | Subjects will not do a bowel preparation. Receives: Other: No bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post surgical day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start17 Feb 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Why it stopped: Loss of faculty members.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to either perform bowel preparation prior to surgery or no bowel preparation.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Aslam, MD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820359
- Sponsor's protocol ID
- 17828
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Very small, local study. Data may not be representative.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Necessity of Bowel Preparation in Minimally Invasive Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT06820359
- Acronym / sponsor ID
- 17828
- Conditions
- Gynecologic Disease
- Keywords
- gynecologic surgery, bowel preparation, patient satisfaction, ease of surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of faculty members.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 17 Feb 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to either perform bowel preparation prior to surgery or no bowel preparation.
| Arm | Type | Receives |
|---|---|---|
| Bowel Preparation | Experimental | Other: Bowel PreparationSubjects will perform bowel preparation using a Fleet saline enema one day before the scheduled procedure. |
| No bowel preparation | Placebo comparator | Other: No bowel preparationSubjects will not do a bowel preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowel PreparationAlso: enemaIndividuals will perform a bowel preparation using a Fleet saline enema. | Other | Bowel Preparation |
| No bowel preparationSubjects will not be required to perform bowel preparation before surgery. | Other | No bowel preparation |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. Very small, local study. Data may not be representative.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Aslam, MD principal investigator
Henry Ford Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel Preparation and No bowel preparation in people with Gynecologic Disease, run by Henry Ford Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician reported ease of surgery (time frame: Immediately following surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.