Comparing bowel preparation methods for colon cancer surgery outcomes
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation
This study is testing whether getting your bowels ready with a special prep before colon cancer surgery can lower the chances of leaks in the surgery compared to not doing any prep at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 586 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT05546892 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the short-term outcomes of colon cancer resections performed after full bowel preparation, which includes mechanical bowel preparation and oral antibiotics, compared to surgeries without any bowel preparation. Eligible patients will be randomly assigned to either the full bowel preparation group or the no preparation group in a 1:1 ratio. The primary outcome measure is the rate of anastomotic leaks within 30 days post-surgery, with a target reduction from 8% to 3%. A total of 586 patients will be enrolled to ensure adequate statistical power for the analysis, following the intent-to-treat principle.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed adenocarcinoma of the colon and indications for surgical resection.
Not a fit: Patients with medical contraindications for surgery, those who have used antibiotics recently, or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing colon cancer resections.
How similar studies have performed: Previous studies have shown varying results regarding bowel preparation methods, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid) * clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable) * indications for surgical colonic resection * ECOG status 0-2 * At least 18 years of age * Written informed consent Exclusion Criteria: * Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol * Pregnancy or breast feeding * Medical contraindications for surgical treatment * Any use of antibiotics 30 days prior to inclusion * Functioning stoma * Contraindications for use of MBP or OA drugs or their components * Indications for mandatory MBP (planned intraoperative colonoscopy etc) * Indications for obstructive resection * Acute bowel obstruction, bleeding or perforation * Other malignancies not in remission
Where this trial is running
Saint Petersburg
- N.N. Petrov National Medical Research Center of Oncology — Saint Petersburg, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Aleksei Karachun
- Email: dr.a.karachun@gmail.com
- Phone: +79219462123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.