Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial
Objective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness. Study design: The study concerns a single-blinded, multicentre, randomised controlled trial. Study population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication. Intervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups. Main study parameters/endpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8. The secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: vNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.
• Written and orally given informed consent
• 18 years and older
• Native Dutch speaker or in control of the Dutch language in speaking and writing
• Indication for hysterectomy for benign indication
• Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination