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

February 17, 2026 updated by: Shaukat Khanum Memorial Cancer Hospital & Research Centre

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients

    • Diagnosed cases of left sided (distal to splenic flexure) colorectal cancer undergoing elective curative sphincter preserving surgery.
    • No contraindication for preoperative administration of oral antibiotics and mechanical bowel preparation.

Exclusion Criteria:

Emergency surgery

  • Palliative surgery
  • Unwilling to participate in a trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mechanical bowel preparation with oral antibiotics
Mechanical bowel preparation arm with oral antibiotics 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.
Drug: Rifampicin (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.
Other Names:
  • Metronidazole
No Intervention: Mechanical bowel preparation without oral antibiotics
Mechanical bowel preparation alone Orally administered preparation of polyethylene glycol 2 days before surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (SSI)
Time Frame: 30 days
Any SSI and the type of SSI (superficial, deep incisional, and organ space) within 30 days of the index procedure based on the Centers for Disease Control and Prevention and National Nosocomial Infection Society criteria
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
anastomotic leak
Time Frame: 30 days
Anastomotic leak: defined as postoperative fluid collection adjacent to the anastomotic site seen on imaging scans and may require a percutaneous drainage procedure and/or an operative intervention.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaukat Khanum Memorial Cancer Hospital & Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 25-28

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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