RCT on 3 Types of Hysterectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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CLINICAL TRIAL PROTOCOL VaNoLaH Trial: A Randomized Controlled Trial Comparing the Vaginal, vNOTES ( Vaginal Natural Orifice Transluminal Surgery) or Laparoscopic Approach for Hysterectomy in Women With Benign Gynaecological Disease

Conditions
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Minimally Invasive Surgery

Intervention / Treatment
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* Procedure: vNOTES vs Vaginal Hysterectomy
* Procedure: vNOTES vs Laparoscopic Hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vNOTES vs Vaginal Hysterectomy<br>Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES | Procedure: vNOTES vs Vaginal Hysterectomy<br>* Comparison of vNOTES vs VH<br>|
| Active Comparator: vNOTES vs Laparoscopic Hysterectomy<br>If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES | Procedure: vNOTES vs Laparoscopic Hysterectomy<br>* Comparison of vNOTES vs LH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of women leaving the hospital within 12 hours after surgery complications. | Day sugery | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion rates | conversion to different surgival technique | 12 hours | 
| duration of the surgical procedure | from placement of Foley to last stich | 12 hours | 
| postoperative complications, | Clavien Dindo | 6 weeks | 
| re-admission requiring hospitalization for at least 24 hours | Readminssion | 6 weeks | 
| The successful removal of adnexa or tubes by planned route of hysterectomy | adnexectomy | 12 hours | 
| Intraoperative complications. | Complication | 12 hours |