Chopstick technique versus cross technique in LESS hysterectomy (CCLEH study): a prospective randomized controlled trial

Abstract Background:The traditional cross technique can be used to complete most Laparoendoscopic single-site surgery (LESS) procedures, but some relatively fine operations, such as vaginal stump suture, are challenging. In practice, we have introduced a novel technique named the chopstick technique and applied it to more complex operations, such as cervical cancer, and found that it contributes to delicate surgery. The efficacy and safety of two different surgical techniques in LESS hysterectomy remain to be validated.Methods:Patients who receive the total hysterectomy are enrolled in this RCT. Stratified randomization will be performed according to uterine size (< 10 weeks, 10-16 weeks, ≥ 16 weeks). The participants will be divided into the chopstick technique group or cross technique group to undergo LESS-TH, then be evaluated the perioperative and postoperative data, including total operation time and other time, transfer rate, estimated blood loss, surgeon fatigue, intraoperative and postoperative complications (within 8 weeks after surgery), health-related quality of life (EQ-5D), postoperative hospital stay, and hospitalization expenses. The primary outcome is the operating time for total hysterectomy under LESS, the other outcomes are secondary. Discussion:It is expected to compare the efficacy of the two techniques in LESS: the chopstick technique vs. the cross technique and accumulate safety data on the new techniques.Trial registration: ChiCTR2000040843, registered on June 16,2020Protocol version:Version 2.0; Date: 2020.05.10