Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

NCT04886791 | Recruiting DMC

• 1 other identifier: NL76240.096.21
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

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.

Conditions

Hysterectomy; Natural Orifice Transluminal Endoscopic Surgery; Vaginal Hysterectomy

Keywords

NOTES surgery; vNOTES; VANH; Vaginal hysterectomy; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Percentage of same day discharge

  Same day discharge

  First 24hours after surgery

Secondary Outcomes (16)

• Complications

  Week 6 after surgery

• Treatment related outcomes-1

  During surgery

• Intended number of salphingectomies in each group

  During surgery

• Performed number of salphingectomies in each group

  During surgery

• Recovery Index-10 (RI-10) pre- and postoperative

  Week 12 after surgery

Study Arms (2)

VANH hysterectomy

EXPERIMENTAL

Access to the peritoneal cavity will be performed similar to vaginal surgery by a circular incision around the cervix, anterior and posterior colpotomy and transsecting the sacro-uterine ligaments. The vNOTES port will be placed to get access to the abdominal cavity and a pneumoperitoneum will be created. After positioning in 20o degree Trendelenburg laparoscopic instruments will be introduced. The peritoneal cavity and ureters are inspected. The hysterectomy is performed by dissecting from caudally to cranially. The fallopian tubes will be removed elective after counselling in the outpatient clinic and the ovaries will be removed on indication only. Haemostasis is checked and the vNOTES port and the uterus are removed trans-vaginally and the pneumoperitoneum is deflated. The vaginal cuff will be closed using a running Vicryl-1 suture. The urinary bladder catheter will be removed directly postoperative.

Procedure: Vaginal NOTES hysterectomy

Vaginal hysterectomy

ACTIVE COMPARATOR

A circumferential incision is made around the cervix. Access to the peritoneal cavity will be performed through anterior and posterior colpotomy. The sacro-uterine ligaments, ligamenta cardinalia uterine arteries will be clamped and dissected. Finally, the ovarian ligament, round ligament and fallopian tubes will be dissected and tied. The uterus will be removed and the vagina will be closed. The urinary bladder catheter will be removed directly postoperative.

Procedure: Vaginal hysterectomy

Interventions

Vaginal NOTES hysterectomy PROCEDURE

Vaginal assited NOTES hysterectomy

VANH hysterectomy

Vaginal hysterectomy PROCEDURE

Vaginal hysterectomy

Vaginal hysterectomy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and orally given informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (2)

Catharina Medical Centre

Eindhoven, North Brabant, Netherlands

NOT YET RECRUITING

Zuyderland Medical Centre

Heerlen, North Brabant, 5644AD, Netherlands

RECRUITING

Related Publications (31)

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MeSH Terms

Interventions

Hysterectomy, Vaginal

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Martine Wassen

  Zuyderland Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilse Bekkers

CONTACT

0031640970334; il.bekkers@zuyderland.nl

Martine Wassen

CONTACT

m.wassen@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is blinded for which surgery they will undergo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in training to be a gynaecologist

Model Details: Single-blinded, multicentre, randomised controlled trial

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 14, 2021
• Study Start: July 5, 2021
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)