Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation

Trial Title: Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation

NCT ID: NCT05546892

Condition: Colon Cancer

Conditions: Official terms:
Colonic Neoplasms

Conditions: Keywords:
colon cancer
MBP
bowel preparation
oral antibiotics

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Full bowel preparation prior to colon resection for cancer
Description: Mechanical bowel preparation and oral antibiotics
Arm group label: Full bowel preparation (MBP+OA)

Intervention type: Procedure
Intervention name: No bowel preparation
Description: Omission of any bowel preparation
Arm group label: No bowel preparation

Summary: The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.

Detailed description: The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups. Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required. The intent-to-treat principle is used for the data analysis.

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: N.N. Petrov National Medical Research Center of Oncology

Address:
City: Saint Petersburg
Zip: 197758
Country: Russian Federation

Status: Recruiting

Contact:
Last name: Aleksei Petrov

Phone: +79214117866
Email: alexpetrov@doctor.com

Investigator:
Last name: Aleksei Karachun
Email: Principal Investigator

Investigator:
Last name: Aleksei Petrov
Email: Sub-Investigator

Start date: February 10, 2023

Completion date: September 2025

Lead sponsor:
Agency: N.N. Petrov National Medical Research Center of Oncology
Agency class: Other

Source: N.N. Petrov National Medical Research Center of Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05546892