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

Colon Cancer Clinical Trial

— COLRABI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546892
• Other study ID #: COL-2
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: September 2025

Study information

• Verified date: March 2023
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: Aleksei Karachun
• Phone: +79219462123
• Email: dr.a.karachun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 586
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• Full bowel preparation prior to colon resection for cancer
Mechanical bowel preparation and oral antibiotics
• No bowel preparation
Omission of any bowel preparation

Locations

Country	Name	City	State
Russian Federation	N.N. Petrov National Medical Research Center of Oncology	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

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