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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: Full bowel preparation prior to colon resection for cancer; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 586
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197758
    • Recruiting
    • N.N. Petrov National Medical Research Center of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full bowel preparation (MBP+OA); Rifaximin 400 mg twice daily for three days prior to surgery Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml	Procedure: Full bowel preparation prior to colon resection for cancer; Mechanical bowel preparation and oral antibiotics
Active Comparator: No bowel preparation; No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)	Procedure: No bowel preparation; Omission of any bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leak rate	Rate of anastomotic leak in patients after colon resections	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall morbidity	Rate of patients with any complications after surgery	30 days
Surgical site infection (SSI) rate	Rate of Surgical site infection	30 days
Intraabdominal and or pelvic abscess rate	Rate of intraabdominal and or pelvic abscess	30 days
Rate of intraoperative complications	Rate of patients with intraoperative complications	Duration of surgical procedure
Surgery duration in minutes	Time of surgical procedure	Duration of surgical procedure
Quality of bowel preparation assessed by surgeon	Assessment of bowel preparation quality by surgeon (qualitative scale)	Day of surgical procedure
Bowel preparation compliance	Rate of patients in experimental arm undergoing complete bowel preparation according to protocol	Day of surgical procedure

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology
• Investigators: Study Chair: Aleksei Karachun, N.N. Petrov National Medical Research Center of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: colon cancer; oral antibiotics; bowel preparation; MBP
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: COL-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No