Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the Netherlands / NCT04886791
Recruiting Not applicable

Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

NCT04886791 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Zuyderland Medisch Centrum
Phase
Not applicable
Started
2021-07-05
Last updated
2025-08-14

Condition(s) studied

HysterectomyNatural Orifice Transluminal Endoscopic SurgeryVaginal Hysterectomy

Investigational drug(s) / intervention(s)

Vaginal NOTES hysterectomyVaginal hysterectomy

Vaginal NOTES hysterectomy: Vaginal assited NOTES hysterectomy

Vaginal hysterectomy: Vaginal hysterectomy

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Catharina Medical Centre Eindhoven North Brabant Not Yet Recruiting
Zuyderland Medical Centre Heerlen North Brabant Recruiting

More Zuyderland Medisch Centrum trials in the Netherlands

Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention Recruiting
fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma Starting soon
Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction Recruiting
OBESE-HFpEF: Towards Preventing Obesity Related HFpEF Recruiting
Cardiovascular-kidney-metabolic (CKM)-Guided Therapy for Patients After Acute Coronary Syndrome Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04886791 on ClinicalTrials.gov ↗ ← All trials in the Netherlands