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

Abstract

BackgroundThe traditional cross technique can be used to complete most laparoendoscopic single-site surgery (LESS) procedures, but some relatively precise operations, such as vaginal stump suturing, 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 operations, and found that it contributes to performing delicate surgery. The efficacy and safety of two different surgical techniques in LESS hysterectomy remain to be validated.MethodsPatients who undergo total hysterectomy will be enrolled in this RCT. Stratified randomization will be performed according to uterine size (< 10 cm, 10–15cm, ≥ 15 cm). The participants will be divided into the chopstick technique group or cross technique group to undergo laparoendoscopic single-site total hysterectomy (LESS-TH), and then the perioperative and postoperative data, including the total operation time and other times, transfer rates, estimated blood loss, surgeon fatigue, intraoperative and postoperative complications (within 8 weeks after surgery), health-related quality of life (EQ-5D) scores, postoperative hospital stay, and hospitalization expenses, will be evaluated. The primary outcome is the operating time for total hysterectomy under LESS, and the other outcomes are secondary outcomes.DiscussionIt is expected that the efficacy of the two techniques in LESS, the chopstick technique vs. the cross technique, will be compared and accumulate safety data on the new techniques will be accumulated.Trial registrationChiCTR2000040843, registered on June 16,2020Protocol version:Version 2.0; Date: 2020.05.10