Minimally Invasive Surgery Clinical Trial
— VANOLAHOfficial 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.
A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Dept of Obstetrics and Gynecology | Zadar | |
Sweden | Dept of Obstetrics and Gynecology | Helsingborg |
Lead Sponsor | Collaborator |
---|---|
Dr Jan Baekelandt, MD |
Croatia, Sweden,
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 |
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