Comparing two types of hysterectomy procedures
Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial
This study is testing whether a new type of vaginal hysterectomy can help women recover faster and have fewer complications compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Eindhoven, North Brabant and 1 other locations) |
| Trial ID | NCT04886791 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare vaginal NOTES hysterectomy with traditional vaginal hysterectomy in terms of same-day discharge, complications, treatment outcomes, post-operative recovery, quality of life, and cost-effectiveness. The study utilizes a single-blinded, multicentre, randomized controlled design to gather data from eligible women undergoing hysterectomy for benign conditions. The trial is motivated by the potential advantages of the vaginal NOTES approach, which may offer less pain and shorter hospital stays compared to other surgical methods.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who require a hysterectomy for benign indications and can undergo a vaginal hysterectomy as assessed by a qualified gynecologist.
Not a fit: Patients with contraindications for vaginal hysterectomy or specific medical histories, such as endometriosis or pelvic inflammatory disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery experiences for women undergoing hysterectomy.
How similar studies have performed: Previous studies have indicated potential benefits of vaginal NOTES procedures, but this specific comparison with vaginal hysterectomy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Eindhoven, North Brabant and 1 other locations
- Catharina Medical Centre — Eindhoven, North Brabant, Netherlands (Not_yet_recruiting)
- Zuyderland Medical Centre — Heerlen, North Brabant, Netherlands (Recruiting)
Study contacts
- Principal investigator: Martine Wassen — Zuyderland Medical Centre
- Study coordinator: Ilse Bekkers
- Email: il.bekkers@zuyderland.nl
- Phone: 0031640970334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.