Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial
Rattachement africain : cn. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
INTRODUCTION: Hysterectomy is the most common surgical procedure in the field of gynaecology. The traditional multiport laparoscopy, transumbilical laparoendoscopic single-site surgery (TU-LESS) and transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy approaches have been implemented to varying degrees in clinical practice. At present, although their feasibility has been proven, there are no large randomised controlled studies on postoperative rehabilitation. This study aims to evaluate postoperative recovery and assess the safety and effectiveness of these three surgical approaches for total laparoscopic hysterectomy. METHOD AND ANALYSIS: This is a multicentre, randomised, single-blind, three-arm, parallel-group, interventional clinical trial. Recruitment will be carried out in five tertiary hospitals in China. Patients diagnosed with benign uterine disease or precancerous lesions will be assigned to the vNOTES group, TU-LESS group and conventional laparoscopy group at a 1:1:1 ratio. The achievement rate of comprehensive indices of enhanced recovery after surgery (ERAS) within 24 hours postoperatively will be considered the primary outcome (the comprehensive indicators of ERAS include fluid intake, passing flatus, urination after catheter removal, ambulation and a Visual Analogue Scale score ≤3.) This study will use a non-inferiority test, with a power (1-ß) of 80% and a margin of -0.15, at a one-sided α of 0.0125. The sample size will be 480 patients (including an assumed 15% dropout rate), calculated according to the primary outcome. ETHICS AND DISSEMINATION: This study was approved on 25 April 2022 by the Medical Ethics Committee of West China Second University Hospital (2022(057)), Sichuan University, Chengdu, China. All participants will be required to provide informed consent before their participation in the study. The results of the trial will be submitted for publication in a peer-reviewed journal and presented at international conferences. PROTOCOL VERSION: V.3.0, 31 August 2023. TRIAL REGISTRATION NUMBER: ChiCTR2200057405.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial
- Date Crossref
- 01/01/2024
- Éditeur
- BMJ
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Army Medical University Department of Obstetrics and Gynecology pays non établi dans la noticeUniversité ou école supérieure
-
Sichuan University pays non établi dans la noticeUniversité ou école supérieure
-
West China Second University Hospital of Sichuan University Department of Gynecologic Oncology pays non établi dans la noticeÉtablissement de santé
-
Southwest Hospital pays non établi dans la noticeÉtablissement de santé
-
Guizhou Provincial People's Hospital Department of Gynecology and Obstetrics pays non établi dans la noticeÉtablissement de santé
-
People’s Hospital of Wenshan Prefecture pays non établi dans la noticeÉtablissement de santé
-
First Affiliated Hospital of Chengdu Medical College pays non établi dans la noticeÉtablissement de santé
-
Department of Gynecologic Oncology pays non établi dans la noticeInstitution
-
Department of Obstetrics and Gynecology pays non établi dans la noticeInstitution
-
Ministry of Education pays non établi dans la noticeOrganisme public
-
Department of Gynecology and Obstetrics pays non établi dans la noticeInstitution
-
The People's Hospital of Wenjiang Chengdu Department of Gynaecology and Obstetrics pays non établi dans la noticeÉtablissement de santé
Department of Obstetrics and Gynecology — Army Medical University, Sichuan University et Department of Gynecologic Oncology — West China Second University Hospital of Sichuan University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.