Effect of local gentamicin-collagen on perineal wound complications and cancer recurrence after abdominoperineal resection: a multicentre randomized controlled trial.

Aim: Perineal wound sepsis is a common problem after abdominoperineal resection of the rectum (APR), with a reported incidence of 10-15% in previously non-irradiated patients, 20-30% in patients given preoperative radiation and 50% among patients submitted to preoperative radiation combined with chemotherapy. The local application of gentamicin-collagen was evaluated to determine whether its use in the perineal wound reduced risk complications and had an effect on cancer recurrence.

Method: In this prospective multicentre (seven hospitals) randomized controlled trial, 102 patients undergoing APR due to cancer or benign disease were randomized into two groups including surgery with gentamicin-collagen (GS+, n = 52) or surgery without gentamicin-collagen (GS-, n = 50). Patients were followed at 7, 30 and 90 days and at 1 and 5 years.

Results: There were no statistically significant differences between the two groups regarding perineal wound complications, infectious or non-infectious, or cancer recurrence.

Conclusion: There was no statistically significant effect on perineal wound complications or cancer recurrence following the local administration of gentamicin-collagen during APR.