Journal of minimally invasive gynecology · 2025
A Randomized Controlled Trial Comparing Surgical Outcomes Between vNOTES and Transumbilical Laparoendoscopic Single-Site Salpingectomy.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Feng Dan, Liu Tianjiao, Xiao Xinyu, Huang Lu, He Li, Lin Yonghong
Аннотация
OBJECTIVE: To compare surgical outcomes, postoperative recovery, and sexual function between transvaginal natural orifice transluminal endoscopic surgery (vNOTES) and transumbilical laparoendoscopic single-site surgery (TU-LESS) for salpingectomy in patients with tubal ectopic pregnancy.
DESIGN: Single-blind randomized controlled trial.
SETTING: University-affiliated tertiary care center specializing in women's and children's health.
PARTICIPANTS: Seventy-two patients with tubal ectopic pregnancy, eligible for laparoendoscopic salpingectomy, were enrolled between January 19 and September 30, 2024. Patients were randomly assigned in a 1:1 ratio to undergo vNOTES or TU-LESS salpingectomy.
INTERVENTIONS: vNOTES or TU-LESS salpingectomy, with perioperative assessment and 3 to 6 months of postoperative follow-up.
RESULTS: Except for the incisional wound assessor, outcome evaluators were blinded to group allocation. The primary outcome, intraoperative conversion rate, was 0 in both groups. Baseline demographic and clinical characteristics were comparable between groups. Compared with TU-LESS, vNOTES was associated with significantly lower pain scores at 12, 24, and 48 hours (all p <.001), shorter operative time (44.89 ± 10.30 vs 50.44 ± 10.31 minutes, p = .025), and reduced postoperative analgesic use (2.8% vs 22.2%, p = .013). No significant differences were observed in intraoperative blood loss, complications, length of hospital stay, or incidence of incisional hernia. Female Sexual Function Index (FSFI) scores remained comparable between groups before and after surgery (p >.05).
CONCLUSION: vNOTES and TU-LESS salpingectomy showed similarly low conversion rates; although the trial was not powered for secondary outcomes, vNOTES deomonstrated better postoperative pain control and cosmetic satisfaction, with postoperative sexual function remaining comparable between approaches.
TRIAL REGISTRATION: ChiCTR2400082909, registered on April 10, 2024 (https://www.chictr.org.cn/showprojEN.html?proj=224201).
DESIGN: Single-blind randomized controlled trial.
SETTING: University-affiliated tertiary care center specializing in women's and children's health.
PARTICIPANTS: Seventy-two patients with tubal ectopic pregnancy, eligible for laparoendoscopic salpingectomy, were enrolled between January 19 and September 30, 2024. Patients were randomly assigned in a 1:1 ratio to undergo vNOTES or TU-LESS salpingectomy.
INTERVENTIONS: vNOTES or TU-LESS salpingectomy, with perioperative assessment and 3 to 6 months of postoperative follow-up.
RESULTS: Except for the incisional wound assessor, outcome evaluators were blinded to group allocation. The primary outcome, intraoperative conversion rate, was 0 in both groups. Baseline demographic and clinical characteristics were comparable between groups. Compared with TU-LESS, vNOTES was associated with significantly lower pain scores at 12, 24, and 48 hours (all p <.001), shorter operative time (44.89 ± 10.30 vs 50.44 ± 10.31 minutes, p = .025), and reduced postoperative analgesic use (2.8% vs 22.2%, p = .013). No significant differences were observed in intraoperative blood loss, complications, length of hospital stay, or incidence of incisional hernia. Female Sexual Function Index (FSFI) scores remained comparable between groups before and after surgery (p >.05).
CONCLUSION: vNOTES and TU-LESS salpingectomy showed similarly low conversion rates; although the trial was not powered for secondary outcomes, vNOTES deomonstrated better postoperative pain control and cosmetic satisfaction, with postoperative sexual function remaining comparable between approaches.
TRIAL REGISTRATION: ChiCTR2400082909, registered on April 10, 2024 (https://www.chictr.org.cn/showprojEN.html?proj=224201).