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

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Full bowel preparation prior to colon resection for cancer
No bowel preparation
Sponsored by
N.N. Petrov National Medical Research Center of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring colon cancer, MBP, bowel preparation, oral antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • N.N. Petrov National Medical Research Center of OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full bowel preparation (MBP+OA)

No bowel preparation

Arm Description

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

No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)

Outcomes

Primary Outcome Measures

Anastomotic leak rate
Rate of anastomotic leak in patients after colon resections

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2022
Last Updated
March 28, 2023
Sponsor
N.N. Petrov National Medical Research Center of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05546892
Brief Title
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation
Acronym
COLRABI
Official Title
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.N. Petrov National Medical Research Center of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colon cancer, MBP, bowel preparation, oral antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
586 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full bowel preparation (MBP+OA)
Arm Type
Experimental
Arm Description
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
Arm Title
No bowel preparation
Arm Type
Active Comparator
Arm Description
No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)
Intervention Type
Procedure
Intervention Name(s)
Full bowel preparation prior to colon resection for cancer
Intervention Description
Mechanical bowel preparation and oral antibiotics
Intervention Type
Procedure
Intervention Name(s)
No bowel preparation
Intervention Description
Omission of any bowel preparation
Primary Outcome Measure Information:
Title
Anastomotic leak rate
Description
Rate of anastomotic leak in patients after colon resections
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Surgical site infection (SSI) rate
Description
Rate of Surgical site infection
Time Frame
30 days
Title
Intraabdominal and or pelvic abscess rate
Description
Rate of intraabdominal and or pelvic abscess
Time Frame
30 days
Title
Overall morbidity
Description
Rate of patients with any complications after surgery
Time Frame
30 days
Title
Rate of intraoperative complications
Description
Rate of patients with intraoperative complications
Time Frame
Duration of surgical procedure
Title
Surgery duration in minutes
Description
Time of surgical procedure
Time Frame
Duration of surgical procedure
Title
Quality of bowel preparation assessed by surgeon
Description
Assessment of bowel preparation quality by surgeon (qualitative scale)
Time Frame
Day of surgical procedure
Title
Bowel preparation compliance
Description
Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Time Frame
Day of surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksei Karachun
Phone
+79219462123
Email
dr.a.karachun@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksei Petrov
Phone
+79214117866
Email
alexpetrov@doctor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksei Karachun
Organizational Affiliation
N.N. Petrov National Medical Research Center of Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
N.N. Petrov National Medical Research Center of Oncology
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksei Petrov
Phone
+79214117866
Email
alexpetrov@doctor.com
First Name & Middle Initial & Last Name & Degree
Aleksei Karachun
First Name & Middle Initial & Last Name & Degree
Aleksei Petrov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to share individual participant data

Learn more about this trial

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

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