Bowel Preparation for Gynecologic Surgery

Recruiting at 1 trial location

Overseen By Nathan Wagstaff, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Muhammad Aslam

Disqualifiers: Open surgery, Under 18, others

Compensation: Varies

Number of Visits: 2

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a bowel prep (a cleansing process) before minimally invasive robotic gynecologic surgery aids the operation. Participants will be randomly assigned to either perform a bowel prep using a Fleet saline enema or skip it. The trial will assess the impact on the surgery's ease and the patient's comfort. It suits those scheduled for this type of surgery and comfortable with performing an enema if assigned. As an unphased trial, this study provides a unique opportunity to contribute to understanding and potentially improving surgical outcomes.

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 prior data suggests that bowel preparation is safe for gynecologic surgery?

Research has shown that bowel preparation, such as enemas, before gynecologic surgery can cause discomfort. Participants who used enemas often felt hungrier, weaker, and experienced more bloating. They also reported increased anal irritation and tiredness compared to those who did not undergo bowel preparation. Although these side effects are uncomfortable, they are usually not harmful. Importantly, bowel preparation does not appear to improve surgical outcomes or reduce infection rates. Therefore, while it may cause some discomfort, it does not add significant risks to the surgery itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether bowel preparation is necessary before gynecologic surgery. Traditionally, bowel prep is a standard step involving methods like enemas to clear the intestines, intended to reduce infection risk. However, this trial is investigating if skipping bowel prep is just as effective, which could simplify pre-surgery routines and improve patient comfort. The potential to eliminate this step without compromising safety is what makes this study particularly intriguing.

What evidence suggests that this trial's treatments could be effective for gynecologic surgery?

This trial will compare the effects of bowel preparation with no bowel preparation for gynecologic surgery. Research has shown that cleaning out the bowels before gynecologic surgery doesn't improve outcomes. Studies have found that methods like enemas neither ease the surgery nor enhance the surgeon's view. In fact, bowel preparation can cause discomfort, such as cramping and irritation. Overall, there is no clear benefit to using bowel preparation for these surgeries. Most experts agree that it doesn't lower infection rates or improve surgical success. ^{1 3 4 6 7}

Who Is on the Research Team?

Muhammad Aslam, MD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Bowel Preparation Experimental Treatment 1 Intervention

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

Group II: No bowel preparation Placebo Group 1 Intervention

Subjects will not do a bowel preparation.

Who Is Running the Clinical Trial?

Muhammad Aslam

Lead Sponsor

Trials

1

Recruited

170+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Bowel Preparation in Minimally Invasive and Vaginal Gynecologic Surgery. Diakosavvas, M., Thomakos, N., Psarris, A., et al.[2020]

No bowel preparation before laparoscopic gynecological surgery showed the highest utility value (0.98), suggesting it may be the best option for minimizing perioperative events and complications.

Magnesium citrate also had a high utility value (0.97) and resulted in the lowest probability of intra- or postoperative complications (8%), making it the preferred choice if bowel preparation is deemed necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of mechanical bowel preparation in laparoscopic gynecologic surgery: a decision analysis. Kantartzis, KL., Shepherd, JP.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 161 patients undergoing gynecologic oncology surgery with colorectal resection, bowel preparation significantly reduced the incidence of surgical-site infections (SSI), with rates of 53% for no preparation, 21% for oral antibiotic bowel preparation (OABP), and 14% for OABP plus mechanical bowel preparation (MBP).

Both OABP and OABP+MBP were associated with a lower risk of SSI compared to no preparation, indicating that bowel preparation is beneficial for these patients, although further research is needed to assess if OABP alone is sufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of bowel preparation with surgical-site infection in gynecologic oncology surgery: Post-hoc analysis of a randomized controlled trial. Moukarzel, LA., Nguyen, N., Zhou, Q., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Mechanical bowel preparation (MBP) before benign laparoscopic or vaginal gynecologic surgeries does not improve surgical outcomes such as surgical field view or bowel handling, based on a review of 13 studies involving 1715 patients.

MBP is associated with increased postoperative pain, weakness, hunger, insomnia, and lower patient satisfaction, suggesting that its routine use should be discontinued due to these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Mechanical Bowel Preparation for Gynecologic Surgeries: A Systematic Review with Meta-analysis. Cardaillac, C., Genest, R., Gauthier, C., et al.[2023]

Current evidence suggests that mechanical bowel preparation (MBP) before elective colorectal surgery may actually increase the risk of wound infections, contradicting its routine use.

In gynecological surgery, limited data indicates that MBP does not provide any significant benefits over not using bowel preparation, further questioning its necessity in surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bowel preparation for gynecological surgery. Muzii, L., Angioli, R., Zullo, MA., et al.[2019]

In a study of 112 patients undergoing colonoscopy, 62% were identified as 'at risk' for adverse events due to factors like age and existing health conditions, but none were flagged before their procedures, highlighting a gap in patient stratification.

Despite high compliance with pre-colonoscopy instructions (97.4% clinical review and 98.3% receiving written instructions), significant adverse events occurred in 4.4% of patients, indicating a need for improved risk assessment and service redesign to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service implications of implementing guidance for oral bowel cleansing agents in colonoscopy. Flanagan, PK., Ahmed, MS., Tin, SM., et al.[2015]

A study of 124 patients undergoing gynecological oncology surgery found that preoperative mechanical bowel preparation (MBP) did not lead to significant differences in surgical outcomes or complications compared to those who did not receive MBP.

The results suggest that MBP is not necessary before gynecological oncology surgery, indicating that it can be safely omitted without affecting patient safety or surgical efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is preoperative bowel preparation necessary for gynecological oncology surgery? Liu, WT., Hsiao, CW., Jao, SW., et al.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7042550/

Preoperative Bowel Preparation in Minimally Invasive and ...

Preparation with enema use does not seem to be more effective when compared to fasting. In gynecologic laparoscopic surgery, using MBP in a form ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1040842803001288

Bowel preparation for gynecological surgery

As to gynecological surgery, data are scanty, and there is a single randomized study reporting no advantage of MBP over no bowel preparation. Based on these ...

3.

withpower.com

withpower.com/trial/phase-genital-diseases-female-1-2025-dfa6e

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 ...

4.

imrpress.com

imrpress.com/journal/CEOG/47/6/10.31083/j.ceog.2020.06.5461/pdf

Effect of bowel preparation before vaginal surgery on ...

Their results showed that abdomi- nal cramping, anal irritation and fatigue were more frequent in the enema group compared to the controls, whereas the surgical ...

5.

researchgate.net

researchgate.net/publication/370562415_Preoperative_mechanical_bowel_preparation_for_gynecologic_surgeries_a_systematic_review_with_meta-analysis

A Systematic Review with Meta-analysis | Request PDF

Conclusions: Mechanical bowel preparation has not been associated with improved surgical field view, bowel handling or operative outcome.

6.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S155346502300170X

Preoperative Mechanical Bowel Preparation for ...

Objective: To assess the efficacy and safety of mechanical bowel preparation before benign laparoscopic or vaginal gynecologic surgeries.

7.

cdn.mdedge.com

cdn.mdedge.com/files/s3fs-public/Document/September-2017/0412_OBGM_Diver.pdf

To prep, or not? Evidence is against mechanical bowel ...

The risks of surgical site infection and anastomotic leakage are not lower with MBP, compared with no preparation, in patients undergoing elective colon surgery ...