OBJECTIVES: The aim of the study was to compare two conization techniques, large loop excision of the transformation zone (LLETZ), and true cone biopsy electrode excision (TCBEE) in women with cervical dysplasia. MATERIALS AND METHODS: In a randomized clinical trial, we compared LLETZ and TCBEE in women undergoing surgical treatment of cervical dysplasia in a 1:1 ratio. The primary endpoint was resection margin status (RMS), secondary endpoints were fragmentation of the surgical specimen, resection volume, operation time, time to complete hemostasis, blood loss, intraoperative and postoperative complications, surgeon's preference, and patient's postoperative pain, estimated by an 11-level visual analog scale (nVAS11), and a 5-level pictogram. RESULTS:One hundred seventy-two women were randomized. No difference in the primary outcome, resection margin status, was observed between LLETZ and TCBEE (involved margins: 12/91 [13%] vs 7/81 [9%], respectively; p = .4). However, fragmentation rate (1 vs >1 fragment: 85 [93%] and 6 [7%] for LLETZ vs 63 [78%] and 18 [22%] for TCBEE; p = .004) and surgeon preference (nVAS11: 1 [0-2] vs 3 [1-7]; p < .001) favored LLETZ. Postoperative pain, however, was lower after TCBEE (nVAS11: 1 [0-3] vs 0 [0-2]; p = .02). The secondary outcome parameters resection volume, operation time, time to complete hemostasis, blood loss, intraoperative complications, and postoperative complications were not different between the study groups. In a multivariate analysis, age, body mass index, and parity did not affect the primary and secondary outcome parameters. CONCLUSIONS:LLETZ and TCBEE are equally safe and efficacious procedures, but specimen fragmentation and surgeon preference favor loop excision.
RCT Entities:
OBJECTIVES: The aim of the study was to compare two conization techniques, large loop excision of the transformation zone (LLETZ), and true cone biopsy electrode excision (TCBEE) in women with cervical dysplasia. MATERIALS AND METHODS: In a randomized clinical trial, we compared LLETZ and TCBEE in women undergoing surgical treatment of cervical dysplasia in a 1:1 ratio. The primary endpoint was resection margin status (RMS), secondary endpoints were fragmentation of the surgical specimen, resection volume, operation time, time to complete hemostasis, blood loss, intraoperative and postoperative complications, surgeon's preference, and patient's postoperative pain, estimated by an 11-level visual analog scale (nVAS11), and a 5-level pictogram. RESULTS: One hundred seventy-two women were randomized. No difference in the primary outcome, resection margin status, was observed between LLETZ and TCBEE (involved margins: 12/91 [13%] vs 7/81 [9%], respectively; p = .4). However, fragmentation rate (1 vs >1 fragment: 85 [93%] and 6 [7%] for LLETZ vs 63 [78%] and 18 [22%] for TCBEE; p = .004) and surgeon preference (nVAS11: 1 [0-2] vs 3 [1-7]; p < .001) favored LLETZ. Postoperative pain, however, was lower after TCBEE (nVAS11: 1 [0-3] vs 0 [0-2]; p = .02). The secondary outcome parameters resection volume, operation time, time to complete hemostasis, blood loss, intraoperative complications, and postoperative complications were not different between the study groups. In a multivariate analysis, age, body mass index, and parity did not affect the primary and secondary outcome parameters. CONCLUSIONS: LLETZ and TCBEE are equally safe and efficacious procedures, but specimen fragmentation and surgeon preference favor loop excision.