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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vNOTES vs Vaginal Hysterectomy | Active Comparator | Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES |
|
| vNOTES vs Laparoscopic Hysterectomy | Active Comparator | If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vNOTES vs Vaginal Hysterectomy | Procedure | Comparison of vNOTES vs VH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of women leaving the hospital within 12 hours after surgery complications. | Day sugery | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization time | Time admitted | 6 weeks |
| conversion rates | conversion to different surgival technique | 12 hours |
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Inclusion Criteria:
• Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Baekelandt, Prof | Contact | 0032499471371 | jan.baekelandt@imelda.be | |
| Jan Baekelandt | Contact | 0032499471371 | jan.baekelandt@imelda.be |
| Name | Affiliation | Role |
|---|---|---|
| JAn Baekelandt | Imeldaziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Obstetrics and Gynecology | Recruiting | Zadar | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41785457 | Derived | Lerner V, Ulrich A, Chen CCG, Baekalandt J. Vaginal Natural Orifice Transluminal Endoscopic Surgery in Minimally Invasive Gynecologic Surgery. Obstet Gynecol. 2026 Apr 1;147(4):e66-e90. doi: 10.1097/AOG.0000000000006198. Epub 2026 Mar 6. | |
| 38658010 | Derived | Baekelandt JF, Stuart A, Wagenius J, Laenen A, Mol BW, Deprest J, Bosteels JJA. VaNoLaH trial: a study protocol-a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy. BMJ Open. 2024 Apr 23;14(4):e081979. doi: 10.1136/bmjopen-2023-081979. |
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| vNOTES vs Laparoscopic Hysterectomy |
| Procedure |
Comparison of vNOTES vs LH |
|
| duration of the surgical procedure | from placement of Foley to last stich | 12 hours |
| Intraoperative complications. | Complication | 12 hours |
| postoperative complications, | Clavien Dindo | 6 weeks |
| re-admission requiring hospitalization | Readminssion | 6 weeks |
| Patient Reported Outcome Measures. | Short Female Sexual Function Index. | 3 months postop |
| Dept of Obstetrics and Gynecology | Recruiting | Helsingborg | 25438 | Sweden |
|