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Mechanical bowel preparation with or without oral antibiotics for rectal resection for cancer (REPCA trial): a study
Aleksandra Olkina1, Aleksei Karachun2, Sergey Bagnenko2
1N.N. Petrov National Medical Research Center of Oncology, 68 Leningradskaya Street, pos. Pesochniy, Saint-Petersburg, Russia. olkina.aleksandra@yandex.ru.
Background:
There is still a lack of randomized trials assessing the clinical value of mechanical bowel preparation (MBP) and oral antibiotics (OA) before rectal surgery. Existing studies are inconsistent regarding OA. The aim of this study is to examine the role of MBP with or without OA (using Alfa Normix®) on postoperative complications in patients undergoing rectal resection for cancer.
Methods:
We are conducting a prospective multicenter randomized controlled trial comparing MBP (Moviprep®) with OA (Alfa Normix®) versus MBP alone in patients undergoing elective rectal resection for cancer. Patients with rectal or rectosigmoid cancer are randomized in a 1:1 allocation ratio. The primary endpoint is incisional surgical site infection (SSI) assessed within 30 days after surgery. Secondary endpoints are anastomotic leakage (AL), organ/space SSI, other postoperative complications, intraoperative complications, operation time, bowel preparation quality, bowel preparation adherence. Intention-to-treat and per protocol analyses will be performed.
Conclusions:
The results of the REPCA trial will demonstrate whether MBP + OA is superior to MBP alone in rectal cancer surgery. This trial might influence current preoperative practice and improve postoperative outcomes.
Insights
This study investigates if mechanical bowel preparation plus oral antibiotics improves outcomes in rectal cancer surgery. Results will clarify the role of oral antibiotics in reducing postoperative complications.
Area of Science:
- Colorectal Surgery
- Surgical Oncology
- Clinical Trials
Background:
- Limited randomized trials exist on mechanical bowel preparation (MBP) and oral antibiotics (OA) for rectal surgery.
- Existing evidence on OA's role in rectal surgery is inconsistent.
- Investigating OA's impact alongside MBP is crucial for optimizing preoperative protocols.
Purpose of the Study:
- To evaluate the clinical value of MBP with or without OA (Alfa Normix®) in reducing postoperative complications.
- To determine if the addition of OA to MBP offers superior outcomes in rectal cancer resection.
- To provide evidence-based guidance for preoperative bowel preparation strategies.
Main Methods:
- Prospective multicenter randomized controlled trial.
- Comparison of MBP (Moviprep®) + OA (Alfa Normix®) versus MBP alone.
- Primary endpoint: Incisional surgical site infection (SSI) within 30 days post-surgery.
- Secondary endpoints include anastomotic leakage and other complications.
Main Results:
- Results are pending from the REPCA trial.
- The study is designed to detect significant differences in SSI rates between the two groups.
- Analysis will also cover secondary outcomes like anastomotic leakage.
Conclusions:
- The REPCA trial will establish whether MBP + OA is superior to MBP alone for rectal cancer surgery.
- Findings may influence current preoperative practices for rectal cancer patients.
- Improved postoperative outcomes are anticipated if the combined approach proves beneficial.
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