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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Full bowel preparation prior to colon resection for cancer
* Procedure: No bowel preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full bowel preparation (MBP+OA)<br>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<br>* Mechanical bowel preparation and oral antibiotics<br>|
| Active Comparator: No bowel preparation<br>No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery) | Procedure: No bowel preparation<br>* Omission of any bowel preparation<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Overall morbidity | Rate of patients with any complications after surgery | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, MBP, bowel preparation, oral antibiotics