Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Full bowel preparationProcedure: Mechanical bowel preparation only
- Registration Number
- NCT04592289
- 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 rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 622
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full bowel preparation (MBP+OA) Full bowel preparation 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 Mechanical bowel preparation only Mechanical bowel preparation only 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
- Primary Outcome Measures
Name Time Method Incisional surgical site infection (SSI) rate 30 days Rate of incisional SSI in patients after rectal resections
- Secondary Outcome Measures
Name Time Method Anastomotic leak rate 30 days Rate of clinical and/or radiological anastomotic leaks
Intraabdominal and or pelvic abscess rate 30 days Surgery duration in minutes Duration of surgical procedure Rate of intraoperative complications Duration of surgical procedure Overall morbidity 30 days Rate of patients with any complications after surgery
Quality of bowel preparation assessed by surgeon Day of surgery Assessment of bowel preparation quality by surgeon (qualitative scale)
Bowel preparation compliance Day of surgery Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Trial Locations
- Locations (7)
GBUZ Moscow Clinical Scientific Center named after Loginov MHD
🇷🇺Moscow, Russian Federation
Ryazan State Clinical Hospital
🇷🇺Ryazan, Russian Federation
Tomsk Regional Oncology Hospital
🇷🇺Tomsk, Russian Federation
Lomonosov Moscow State University Medical Research and Educational Center
🇷🇺Moscow, Russian Federation
Scientific-Research institute of Oncology named after N.N. Petrov
🇷🇺Saint Petersburg, Russian Federation
Volgograd State Medical University, Ministry of Health of Russia
🇷🇺Volgograd, Russian Federation
I.M. Sechenov First Moscow State Medical University, Clinic of Oncology, Radiotherapy and Reconstructive Surgery
🇷🇺Moscow, Russian Federation