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To Prepare Or Not the Colon for Elective Surgery with Primary Intraperitoneal Anastomosis. There Is No Question
María JesúS Peña-Soria, Julio M. Mayol*, Rocio Anula, Ana M. Arbeo-Escolar, Jesus a. Fernandez-Represa
Servicio de Cirugia I, Hospital Clinico San Carlos, Madrid, Spain
Introduction: The definitive analysis of a prospective single-blinded randomized trial to investigate whether preoperative mechanical bowel preparation decreases the incidence of surgical site infection and anastomotic failure after elective colorectal surgery by a single surgeon is presented.Patients and
Methods: All patients scheduled to undergo an elective colorectal procedure with a primary anastomosis by the same surgeon from October 2001 until January 2007 were enrolled and randomized to receive either oral polyethylene glycol (PEG) lavage solution (Group A) or no mechanical bowel preparation whatsoever (MBP)(Group B). Dietary restrictions were limited to 12 hours prior to surgery. A standard intravenous antibiotic prophylaxis scheme was used. Exclusion criteria included immunosupression, preoperative chemoradiotherapy, diverting stoma and perforated and/or obstructing tumor. Patients were followed by an independent observer for wound infection, intrabdominal sepsis and anastomotic failure within 30 days after surgery. Student’s T and Chi square tests were used for statistical analysis. Statistical significance was defined as p<0.05. The number of patients needed to treat (NNT) was calculated as the inverse of the absolute risk reduction. The study was approved by Hospital Clinico San Carlos ethics committee.
Results: One hundred and forty five patients were enrolled. Three patients (2.06%) were preoperatively excluded because of active immunosupression. One hundred and forty two patients were randomized but 13 of them (8.9%) were excluded from analysis (diverting stoma in 10 cases, contained perforation in 1 patient and unresectable tumor in 2 patients). Of the remaining 129 patients, 64 were assigned to Group A and 65 to Group B. The mean age was 67.39 ± 15.9 years in Group A and 67.2 ± 12.6 years in Group B (NS). There was no difference in sex distribution between groups. Overall, 27 patients (20.9%) developed postoperative wound infection, 16 (24.6%) patients in Group A vs. 11 (17.2%) in Group B (NS). There were 3 cases of intrabdominal sepsis and all of them occurred in Group A (6.3%). The SSI rate was 29.7% (19/64) for Group A vs. 17.2% (11/65) for group B (NS). The overall rate of anastomotic failure was 5.4% (n = 7), 4 patients in Group A (6.2%) vs. 3 patients in Group B (4.6%) (NS). The overall complication rate (SSI+ anastomotic failure) in Group A was 35.9% vs., 21.5% in Group B (NS). The NNT was 7.
Conclusion: the NNT in our definitive analysis suggests that better outcomes in terms of SSI and anastomotic failure rates would be achieved by a single surgeon if preoperative MBP with PEG is routinely omitted.
