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Enrolling By InvitationNCT07429760

Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery

Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery: A Randomized Trial (MEBOA Trial)

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

In this study, Investigator will compare mechanical bowel preparation with or without oral antibiotics in Left sided colorectal cancer patients undergoing elective surgery.

Detailed description

Surgical site infection (SSI) after colorectal surgery is a common postoperative complication, with rates of 15% to 20%, and significantly affects patient morbidity and mortality. Given the high frequency of SSIs following colorectal procedures and the limited effectiveness of other preventive strategies, the combination of oral antibiotics with mechanical bowel preparation (MBP)-a technique initially evaluated in the 1970s but later discontinued-has regained attention as a potentially effective preventive approach. Recent studies have evaluated the combination of oral antibiotics and mechanical bowel preparation (MBP) with perioperative intravenous antibiotics, showing a significant reduction in the rate of surgical site infections (SSIs). The Enhanced Recovery After Surgery (ERAS) Society indicates that randomized controlled trials provide some evidence supporting the use of both mechanical bowel preparation and oral antibiotics together, rather than using mechanical bowel preparation alone. American Society of Colon and Rectal Surgeons (ASCRS) Clinical Practice Guidelines also advise the combined use of mechanical bowel preparation and oral antibiotics for patients undergoing elective colorectal surgery. Mechanical bowel preparation before right sided colonic surgery offers no clinical benefit and may lead to preoperative dehydration, electrolyte imbalances, and patient discomfort. However, MBP is beneficial in left sided colorectal rectal surgery. Despite growing evidence supporting the use of oral antibiotics combined with mechanical bowel preparation (MBP), significant variability in clinical practice persists. In current practice, oral antibiotics are not routinely prescribed for colorectal cancer patients, so this will be interesting to evaluate the effect of oral antibiotics in this population.

Conditions

Interventions

TypeNameDescription
DRUGRifampicin (R)Orally administered preparation of polyethylene glycol 2 days before surgery+ three doses of rifaximin 400mg at 7am, 3pm and 11pm the day before surgery and a single dose of metronidazole 500mg 11pm the day before surgery.

Timeline

Start date
2025-08-01
Primary completion
2026-08-30
Completion
2026-08-30
First posted
2026-02-24
Last updated
2026-02-24

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07429760. Inclusion in this directory is not an endorsement.