INTRODUCTION: We report the final analysis of a prospective single-blinded randomized trial designed to investigate whether omission of preoperative mechanical bowel preparation increases the rate of surgical-site infection and anastomotic failure after elective colon surgery with intraperitoneal anastomosis by a single surgeon. PATIENTS AND METHODS: Patients scheduled to undergo an elective colon or proximal rectal resection with a primary anastomosis by a single surgeon were randomized to receive either oral polyethylene glycol (Group A) or no mechanical bowel preparation (Group B). Patients were followed by an independent surgeon. RESULTS:One hundred and forty nine patients were enrolled. Three patients (2%) were preoperatively excluded because of active immunosuppression and 13 (9%) were excluded from the final analysis. Of the remaining 129 patients, 65 were assigned to Group A and 64 to Group B. Thirty patients (23.2%) developed wound infection, (Group A = 24.6% and Group B = 17.2%; NS). There were three cases of intra-abdominal sepsis a (Group A 4.6%). The anastomotic failure rate was 5.4% (n = 7), four patients in Group A (6.2%) vs. three patients in Group B (4.7%) (NS). When SSI and anastomotic failure were combined, the complication rate in Group A was 35.4% vs. 21.9% for Group B. The NNH was 7.4. CONCLUSION: Our final analysis shows that a single surgeon will not have a higher rate of either surgical-site infection or anastomotic failure if he/she routinely omits preoperative mechanical bowel preparation.
RCT Entities:
INTRODUCTION: We report the final analysis of a prospective single-blinded randomized trial designed to investigate whether omission of preoperative mechanical bowel preparation increases the rate of surgical-site infection and anastomotic failure after elective colon surgery with intraperitoneal anastomosis by a single surgeon. PATIENTS AND METHODS: Patients scheduled to undergo an elective colon or proximal rectal resection with a primary anastomosis by a single surgeon were randomized to receive either oral polyethylene glycol (Group A) or no mechanical bowel preparation (Group B). Patients were followed by an independent surgeon. RESULTS: One hundred and forty nine patients were enrolled. Three patients (2%) were preoperatively excluded because of active immunosuppression and 13 (9%) were excluded from the final analysis. Of the remaining 129 patients, 65 were assigned to Group A and 64 to Group B. Thirty patients (23.2%) developed wound infection, (Group A = 24.6% and Group B = 17.2%; NS). There were three cases of intra-abdominal sepsis a (Group A 4.6%). The anastomotic failure rate was 5.4% (n = 7), four patients in Group A (6.2%) vs. three patients in Group B (4.7%) (NS). When SSI and anastomotic failure were combined, the complication rate in Group A was 35.4% vs. 21.9% for Group B. The NNH was 7.4. CONCLUSION: Our final analysis shows that a single surgeon will not have a higher rate of either surgical-site infection or anastomotic failure if he/she routinely omits preoperative mechanical bowel preparation.
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