RCT on 3 Types of Hysterectomy

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.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05971875

Acronym

VANOLAH

Enrollment

1000

Registered

2023-08-02

Start date

2024-01-01

Completion date

2026-01-01

Last updated

2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally Invasive Surgery

Brief 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

Detailed 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.

Interventions

PROCEDUREvNOTES vs Vaginal Hysterectomy

Comparison of vNOTES vs VH

PROCEDUREvNOTES vs Laparoscopic Hysterectomy

Comparison of vNOTES vs LH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
proportion of women leaving the hospital within 12 hours after surgery complications.	12 hours	Day sugery

Secondary

Measure	Time frame	Description
conversion rates	12 hours	conversion to different surgival technique
duration of the surgical procedure	12 hours	from placement of Foley to last stich
Intraoperative complications.	12 hours	Complication
Hospitalization time	6 weeks	Time admitted
re-admission requiring hospitalization	6 weeks	Readminssion
Patient Reported Outcome Measures.	3 months postop	Short Female Sexual Function Index.
postoperative complications,	6 weeks	Clavien Dindo

Countries

Croatia, Sweden

Contacts

Primary ContactJan Baekelandt, Prof

jan.baekelandt@imelda.be0032499471371

Backup ContactJan Baekelandt