Bowel Preparation for Gynecologic Surgery

Recruiting at 1 trial location

Overseen by Muhammad Aslam, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Muhammad Aslam

Disqualifiers: Open surgery, Under 18, others

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 6 8 9}

Research Team

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

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

Trial 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 (Procedure)
• No bowel preparation (Procedure)

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

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preoperative Bowel Preparation in Minimally Invasive and Vaginal Gynecologic Surgery. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Controversies in preoperative bowel preparation in gynecologic and gynecologic oncology surgery: a review of the literature. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preoperative Mechanical Bowel Preparation for Gynecologic Surgeries: A Systematic Review with Meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Service implications of implementing guidance for oral bowel cleansing agents in colonoscopy. [2015]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Bowel preparation for gynecological surgery. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The use of mechanical bowel preparation in laparoscopic gynecologic surgery: a decision analysis. [2015]