Colorectal CancerNCT07429760
Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery
A study testing Rifampicin (R) in people with Colorectal Cancer, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
In this study, Investigator will compare mechanical bowel preparation with or without oral antibiotics in Left sided colorectal cancer patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Rifampicin (R)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Emergency surgery
- Palliative surgery
- Unwilling to participate in a trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore
Lahore, Punjab Province
About this study
Official title: 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.
Read the 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
- Colorectal Cancer
- Being tested
- Rifampicin (R)
- Keywords
- Colorectal Cancer, Oral Antibiotics, Mechanical bowel preparation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifampicin (R)Drug
Also called Metronidazole
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.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical bowel preparation with oral antibiotics | Experimental | 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. Receives: Drug: Rifampicin (R) |
| Mechanical bowel preparation without oral antibiotics | No intervention | Mechanical bowel preparation alone Orally administered preparation of polyethylene glycol 2 days before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI)
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
Measured: 30 days
Secondary outcomes (1)
anastomotic leak
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Aug 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429760
- Sponsor's protocol ID
- IRB 25-28
- Status last verified
- Feb 2026
- First submitted
- 8 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery: A Randomized Trial (MEBOA Trial)
- ClinicalTrials.gov ID
- NCT07429760
- Acronym / sponsor ID
- IRB 25-28
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Oral Antibiotics, Mechanical bowel preparation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical bowel preparation with oral antibiotics | Experimental | Drug: Rifampicin (R)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. |
| Mechanical bowel preparation without oral antibiotics | No intervention | –Mechanical bowel preparation alone Orally administered preparation of polyethylene glycol 2 days before surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients
Key exclusion criteria (3 listed)
- Emergency surgery
- Palliative surgery
- Unwilling to participate in a trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifampicin (R)Also: MetronidazoleOrally 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 | Mechanical bowel preparation with oral antibiotics |
Primary outcome
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
1 secondary outcome
anastomotic leak
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifampicin (R) in people with Colorectal Cancer, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (SSI) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.