RCT on 3 Types of Hysterectomy

Minimally Invasive Surgery Clinical Trial

— VANOLAH  

Official title:

A Multinational Randomized Controlled Trial Including Two Identical Sub Studies Comparing Vaginal Versus vNOTES (Vaginal Natural Orifice Transluminal Surgery) Hysterectomy or Laparoscopic Versus vNOTES Hysterectomy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971875
• Other study ID #: Vanolah
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Imelda Hospital, Bonheiden
• Contact: Jan Baekelandt, Prof
• Phone: 0032499471371
• Email: jan.baekelandt[@]imelda.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease

Description:

Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy

Exclusion Criteria:

• Women with a stage II+ prolapse in need of a hysterectomy as part of vaginal prolapse repair

• hysterectomy due to suspected endometriosis

• subtotal hysterectomy

• history of rectal surgery

• suspected malignancy

• suspected obliteration of the pouch of Douglas following severe PID or other causes

• active lower genital tract infection

• pregnancy

• failure to provide written informed consent prior to surgery

• requirement of in-patient care due to other co-morbidities

Related Conditions & MeSH terms

• Minimally Invasive Surgery

Intervention

Procedure:
• vNOTES vs Vaginal Hysterectomy
Comparison of vNOTES vs VH
• vNOTES vs Laparoscopic Hysterectomy
Comparison of vNOTES vs LH

Locations

Country	Name	City	State
Croatia	Dept of Obstetrics and Gynecology	Zadar
Sweden	Dept of Obstetrics and Gynecology	Helsingborg

Sponsors (1)

Lead Sponsor	Collaborator
Dr Jan Baekelandt, MD

Countries where clinical trial is conducted

Croatia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of women leaving the hospital within 12 hours after surgery complications.	Day sugery	12 hours
Secondary	Hospitalization time	Time admitted	6 weeks
Secondary	conversion rates	conversion to different surgival technique	12 hours
Secondary	duration of the surgical procedure	from placement of Foley to last stich	12 hours
Secondary	Intraoperative complications.	Complication	12 hours
Secondary	postoperative complications,	Clavien Dindo	6 weeks
Secondary	re-admission requiring hospitalization	Readminssion	6 weeks
Secondary	Patient Reported Outcome Measures.	Short Female Sexual Function Index.	3 months postop