OBJECTIVE: The study was carried out to evaluate the efficacy of the gentamycin collagen sponge placed in the pelvic cavity after excision of rectal cancer in view of postoperative complications and the risk of cancer recurrence. METHODS:A total of 229 patients were recruited into the study and randomized into two groups: GRM(+), in which a gentamycin collagen sponge was used, and GRM(-), without the sponge. Tumors were resected using a TME technique. In the GRM(+) group, the sponge was placed into the tumor bed. RESULTS: Analysis covered 218 patients for whom all follow-up data were available. There were fewer early postoperative complications in the GRM(+) group: 20.7 vs. 37.5%; p=0.044. This effect was found mainly in patients with surgery lasting longer than 3 h. After 36 months' follow-up, the overall survival after R0 resection for the GRM(+) and GRM(-) groups was: 88.66 vs. 73.96%. There was significant reduction in the distant metastasis rate in favor of the GRM(+) group. CONCLUSION: The use of the gentamycin collagen sponge after excision of rectal cancer is safe and reduces the rate of early postoperative complications. The reasons for the lower rate of distant metastasis in the GRM(+) group are not clear, but the patients enjoy significant survival benefits.
RCT Entities:
OBJECTIVE: The study was carried out to evaluate the efficacy of the gentamycin collagen sponge placed in the pelvic cavity after excision of rectal cancer in view of postoperative complications and the risk of cancer recurrence. METHODS: A total of 229 patients were recruited into the study and randomized into two groups: GRM(+), in which a gentamycin collagen sponge was used, and GRM(-), without the sponge. Tumors were resected using a TME technique. In the GRM(+) group, the sponge was placed into the tumor bed. RESULTS: Analysis covered 218 patients for whom all follow-up data were available. There were fewer early postoperative complications in the GRM(+) group: 20.7 vs. 37.5%; p=0.044. This effect was found mainly in patients with surgery lasting longer than 3 h. After 36 months' follow-up, the overall survival after R0 resection for the GRM(+) and GRM(-) groups was: 88.66 vs. 73.96%. There was significant reduction in the distant metastasis rate in favor of the GRM(+) group. CONCLUSION: The use of the gentamycin collagen sponge after excision of rectal cancer is safe and reduces the rate of early postoperative complications. The reasons for the lower rate of distant metastasis in the GRM(+) group are not clear, but the patients enjoy significant survival benefits.
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