NCT04886791 Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy
| NCT ID | NCT04886791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zuyderland Medisch Centrum |
| Condition | Hysterectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2021-07-05 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 124 participants in total. It began in 2021-07-05 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist * History of more than 1 caesarean section * History of endometriosis * History of rectal surgery * History of pelvic radiation * Suspected rectovaginal endometriosis * History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis) * Virginity * Pregnancy * Indication for anterior or posterior colporrhaphy during the same surgery * Indication of mid urethral slings * Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.
Contact & Investigator
Martine Wassen
PRINCIPAL INVESTIGATOR
Zuyderland Medical Centre
Frequently Asked Questions
Who can join the NCT04886791 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hysterectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04886791 currently recruiting?
Yes, NCT04886791 is actively recruiting participants. Contact the research team at il.bekkers@zuyderland.nl for enrollment information.
Where is the NCT04886791 trial being conducted?
This trial is being conducted at Eindhoven, Netherlands, Heerlen, Netherlands.
Who is sponsoring the NCT04886791 clinical trial?
NCT04886791 is sponsored by Zuyderland Medisch Centrum. The principal investigator is Martine Wassen at Zuyderland Medical Centre. The trial plans to enroll 124 participants.