Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone

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 rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.

Detailed Description
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The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal 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 surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 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 Rectal Resections for Cancer Versus MBP Alone

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Full bowel preparation
* Procedure: Mechanical bowel preparation only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable) indications for surgical rectal 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 obstructive resection or abdominoperineal excision 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 Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml | Procedure: Full bowel preparation<br>* MBP+OA<br>|
| Active Comparator: Mechanical bowel preparation only<br>Day prior to surgery: 17.00 - 18.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 18.00 - 19.00 Clear fluids 500 ml 19.00 - 20.00 Macrogol-3350 - 100 g Sodium sulfate - 7,5 g Sodium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Sodium ascorbate - 5,9 g Clear fluids - 1000 ml 20.00 - 21.00 Clear fluids 500 ml | Procedure: Mechanical bowel preparation only<br>* MBP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional surgical site infection (SSI) rate | Rate of incisional SSI in patients after rectal resections | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak rate | Rate of clinical and/or radiological anastomotic leaks | 30 days | 
| Intraabdominal and or pelvic abscess rate |  | 30 days | 
| Overall morbidity | Rate of patients with any complications after surgery | 30 days | 
| Rate of intraoperative complications |  | Duration of surgical procedure | 
| Surgery duration in minutes |  | Duration of surgical procedure | 
| Quality of bowel preparation assessed by surgeon | Assessment of bowel preparation quality by surgeon (qualitative scale) | Day of surgery | 
| Bowel preparation compliance | Rate of patients in experimental arm undergoing complete bowel preparation according to protocol | Day of surgery | 

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