Feasibility, safety, and clinical outcomes of modified laparoscopic cervicoisthmic cerclage for refractory cervical insufficiency: A single-arm clinical trial-Part 1.

Abstract

Aim: To assess the feasibility, safety, and outcomes of modified laparoscopic transabdominal cerclage in patients with refractory cervical insufficiency.

Methods: This single-arm clinical trial examined women with refractory cervical insufficiency who underwent modified laparoscopic transabdominal cerclage at a specialized center in Japan between December 2017 and May 2022. Various parameters related to patient demographics, surgical techniques, outcomes, and complications were evaluated.

Results: The study enrolled 30 women with a median age of 36 years. The modified laparoscopic transabdominal cerclage was technically successful in all cases. The delivery rate and fetal survival rate at 28 days in the third trimester were both 93%. Surgical complication involving small bowel injury occurred in one case and was promptly repaired. No fetal complications or pregnancy losses occurred within 28 days of the procedure. Perinatal outcomes included a cesarean section rate of 93%, a neonatal intensive care unit admission rate of 30%, and an overall fetal survival rate of 93%. Additionally, no absence or reversal of end-diastolic flow in the uterine artery was identified at the time of cerclage in any of the cases.

Conclusions: This study demonstrated the feasibility and safety of modified laparoscopic transabdominal cerclage for refractory cervical insufficiency. The procedure achieved a high delivery rate in the third trimester and a good overall fetal survival rate. The study findings highlight the importance of anatomical precision during thread placement in modified laparoscopic transabdominal cerclage. This technique is promising for treating refractory cervical insufficiency and potentially preventing second-trimester losses and extreme preterm births.