Comparing bowel preparation methods for rectal cancer surgery

Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone

This study is testing if adding oral antibiotics to bowel preparation before rectal cancer surgery can help reduce infections after the operation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 622 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: N.N. Petrov National Medical Research Center of Oncology (other)
• Locations: 7 sites (Moscow and 6 other locations)
• Trial ID: NCT04592289 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the short-term outcomes of rectal resections for cancer by comparing two bowel preparation methods: full bowel preparation that includes mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation alone. Eligible patients will be randomly assigned to one of the two groups in a 1:1 ratio, and the outcomes will be assessed within 30 days post-surgery. The primary focus is to determine if the addition of oral antibiotics can significantly reduce the rate of surgical site infections. A total of 622 patients will be enrolled to ensure adequate statistical power for the analysis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction who are scheduled for surgical resection.

Not a fit: Patients with medical contraindications for surgery, recent antibiotic use, or 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 infection rates for patients undergoing rectal cancer surgery.

How similar studies have performed: Previous studies have indicated that enhanced bowel preparation methods can lead to better surgical outcomes, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction
* clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
* indications for surgical rectal 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 obstructive resection or abdominoperineal excision
* Acute bowel obstruction, bleeding or perforation
* Other malignancies not in remission

Where this trial is running

Moscow and 6 other locations

• GBUZ Moscow Clinical Scientific Center named after Loginov MHD — Moscow, Russian Federation (RECRUITING)
• I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery — Moscow, Russian Federation (RECRUITING)
• Lomonosov Moscow State University Medical Research and Educational Center — Moscow, Russian Federation (RECRUITING)
• Ryazan State Clinical Hospital — Ryazan, Russian Federation (RECRUITING)
• Scientific-Research institute of Oncology named after N.N. Petrov — Saint Petersburg, Russian Federation (RECRUITING)
• Tomsk Regional Oncology Hospital — Tomsk, Russian Federation (RECRUITING)
• Volgograd State Medical University, Ministry of Health of Russia — Volgograd, Russian Federation (RECRUITING)

Study contacts

• Study coordinator: Aleksei Karachun

Conditions: Rectal Cancer, rectal cancer, bowel preparation, MBP, Oral antibiotics