Xiang Yang1, Huaifang Li. 1. Department of Obstetrics and Gynecology, Tongji Hospital of Tongji University, 389 Xincun Rd., Shanghai, China.
Abstract
OBJECTIVE: To evaluate, in terms of efficacy and safety, a modified anterior compartment reconstruction procedure for anterior pelvic organ prolapse (POP). METHODS: The patients were assigned to two groups according to their individual willingness and economical condition, of whom 68 were treated with the modified procedure and 37 with the 'Prolift-a' procedure. The objective cure rate was defined by 0 or I according to POP-Q, which was detected by non-inferiority test between the two groups. RESULTS: The cure rates were found to be 94.1% (64/68) in the modified group and 97.3% (36/37) in the Prolift-a group, respectively. No significant difference was found between these two groups in the cure rate by non-inferiority test (u = 2.252, P = 0.012). The blood loss and hospitalization costs were significantly lower in the modified group than the Prolift-a group (P < 0.05), while other clinical parameters showed no significant difference between the two groups (P > 0.05). CONCLUSION: Both the modified total pelvic reconstruction and Prolift-a operations are safe, efficacious and minimally invasive surgical treatments, while the modified procedure is relatively inexpensive, which has great perspective of clinical application in developing countries.
RCT Entities:
OBJECTIVE: To evaluate, in terms of efficacy and safety, a modified anterior compartment reconstruction procedure for anterior pelvic organ prolapse (POP). METHODS: The patients were assigned to two groups according to their individual willingness and economical condition, of whom 68 were treated with the modified procedure and 37 with the 'Prolift-a' procedure. The objective cure rate was defined by 0 or I according to POP-Q, which was detected by non-inferiority test between the two groups. RESULTS: The cure rates were found to be 94.1% (64/68) in the modified group and 97.3% (36/37) in the Prolift-a group, respectively. No significant difference was found between these two groups in the cure rate by non-inferiority test (u = 2.252, P = 0.012). The blood loss and hospitalization costs were significantly lower in the modified group than the Prolift-a group (P < 0.05), while other clinical parameters showed no significant difference between the two groups (P > 0.05). CONCLUSION: Both the modified total pelvic reconstruction and Prolift-a operations are safe, efficacious and minimally invasive surgical treatments, while the modified procedure is relatively inexpensive, which has great perspective of clinical application in developing countries.