Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation
- Conditions
- Colon Cancer
- Interventions
- Procedure: No bowel preparationProcedure: Full bowel preparation prior to colon resection for cancer
- Registration Number
- NCT05546892
- Lead Sponsor
- N.N. Petrov National Medical Research Center of Oncology
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 586
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No bowel preparation No bowel preparation No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery) Full bowel preparation (MBP+OA) Full bowel preparation prior to colon resection for cancer 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
- Primary Outcome Measures
Name Time Method Anastomotic leak rate 30 days Rate of anastomotic leak in patients after colon resections
- Secondary Outcome Measures
Name Time Method Intraabdominal and or pelvic abscess rate 30 days Rate of intraabdominal and or pelvic abscess
Rate of intraoperative complications Duration of surgical procedure Rate of patients with intraoperative complications
Quality of bowel preparation assessed by surgeon Day of surgical procedure Assessment of bowel preparation quality by surgeon (qualitative scale)
Surgical site infection (SSI) rate 30 days Rate of Surgical site infection
Overall morbidity 30 days Rate of patients with any complications after surgery
Surgery duration in minutes Duration of surgical procedure Time of surgical procedure
Bowel preparation compliance Day of surgical procedure Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Trial Locations
- Locations (1)
N.N. Petrov National Medical Research Center of Oncology
🇷🇺Saint Petersburg, Russian Federation