166 Participants Needed

Bowel Preparation for Gynecologic Surgery

Recruiting at 1 trial location
MA
NW
Overseen ByNathan Wagstaff, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Muhammad Aslam

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Bowel Preparation for gynecologic surgery?

Research shows that bowel preparation does not improve surgical outcomes or reduce infection rates in gynecologic surgeries. Most studies suggest that it offers no advantage and should be omitted before minimally invasive and vaginal gynecologic surgeries.12345

Is bowel preparation safe for gynecologic surgery?

Bowel preparation has been used for many years, but recent studies suggest it may not be necessary for gynecologic surgeries and could lead to higher infection rates. Some guidance advises against its routine use due to potential risks.13678

How does bowel preparation differ from other treatments for gynecologic surgery?

Bowel preparation involves cleaning out the intestines before surgery, but recent studies suggest it doesn't reduce infection risk or improve surgical outcomes in gynecologic procedures. Unlike other treatments, it is based more on tradition than solid evidence, and many experts now recommend against its routine use in these surgeries.13689

What is the purpose of 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.

Research Team

MA

Muhammad Aslam, MD

Principal Investigator

Henry Ford Health

Eligibility Criteria

This trial is for patients scheduled for minimally invasive robotic gynecologic surgery. Specific eligibility criteria are not provided, but typically participants would need to be in good health and have a diagnosis that requires the surgery.

Inclusion Criteria

I am willing to use an enema if needed for the study.
Able to read and understand English
Willing to sign an informed consent form
See 1 more

Exclusion Criteria

I am scheduled for surgery that involves opening my body.
I am not willing to perform an enema if required.
Unable to read and understand English
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Preparation

Participants are randomized to either perform bowel preparation using a Fleet saline enema or not, one day before the scheduled procedure

1 day
1 visit (in-person)

Surgery and Immediate Postoperative Assessment

Participants undergo minimally invasive robotic gynecologic surgery. Data collection on patient satisfaction and pain control is performed on postoperative day one prior to discharge

1 day
1 visit (in-person)

Follow-up

Participants are monitored for hospital readmissions, surgical site infections, and urinary tract infections up to 12 weeks post-discharge

12 weeks

Treatment Details

Interventions

  • Bowel Preparation
  • No bowel preparation
Trial Overview The study is testing whether pre-surgical bowel preparation affects the ease of surgery, intraoperative visualization, and bowel handling compared to no bowel preparation. It's a randomized study, meaning patients will be randomly assigned to one of the two approaches.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bowel PreparationExperimental Treatment1 Intervention
Subjects will perform bowel preparation using a Fleet saline enema one day before the scheduled procedure.
Group II: No bowel preparationPlacebo Group1 Intervention
Subjects will not do a bowel preparation.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Muhammad Aslam

Lead Sponsor

Trials
1
Recruited
170+

Findings from Research

A systematic review of studies on bowel preparation before minimally invasive and vaginal gynecologic surgeries found no significant benefits in reducing postoperative infections or improving surgical performance, despite its long-standing use.
Current evidence suggests that routine bowel preparation should be omitted prior to these surgeries, as most scientific societies now recommend against it due to low infection rates and minimal risk of bowel entry during procedures.
Preoperative Bowel Preparation in Minimally Invasive and Vaginal Gynecologic Surgery.Diakosavvas, M., Thomakos, N., Psarris, A., et al.[2020]
Current guidelines for bowel preparation before gynecologic surgeries are inconsistent, and there is no strong evidence supporting the routine use of mechanical bowel preparation due to potential adverse effects.
However, combining oral antibiotics with mechanical bowel preparation has shown benefits in reducing postoperative complications in colorectal surgeries, suggesting that this approach may be useful in more complex gynecologic cases, particularly in gynecologic oncology.
Controversies in preoperative bowel preparation in gynecologic and gynecologic oncology surgery: a review of the literature.Diakosavvas, M., Thomakos, N., Haidopoulos, D., et al.[2021]
In a study of 224,687 women who underwent hysterectomy, bowel preparation (mechanical, oral antibiotics, or a combination) did not reduce the rates of surgical site infections or anastomotic leaks compared to no bowel preparation.
The findings suggest that bowel preparation can be safely omitted before both benign and malignant hysterectomies, as it does not contribute to improved surgical outcomes.
Use of bowel preparation does not reduce postoperative infectious morbidity following minimally invasive or open hysterectomies.Kalogera, E., Van Houten, HK., Sangaralingham, LR., et al.[2020]

References

Preoperative Bowel Preparation in Minimally Invasive and Vaginal Gynecologic Surgery. [2020]
Controversies in preoperative bowel preparation in gynecologic and gynecologic oncology surgery: a review of the literature. [2021]
Use of bowel preparation does not reduce postoperative infectious morbidity following minimally invasive or open hysterectomies. [2020]
4.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Is preoperative bowel preparation necessary for gynecological oncology surgery? [2017]
Association of bowel preparation with surgical-site infection in gynecologic oncology surgery: Post-hoc analysis of a randomized controlled trial. [2023]
Preoperative Mechanical Bowel Preparation for Gynecologic Surgeries: A Systematic Review with Meta-analysis. [2023]
Service implications of implementing guidance for oral bowel cleansing agents in colonoscopy. [2015]
Bowel preparation for gynecological surgery. [2019]
The use of mechanical bowel preparation in laparoscopic gynecologic surgery: a decision analysis. [2015]
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