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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Comparison of vNOTES vs VH
Comparison of vNOTES vs LH
Dept of Obstetrics and Gynecology
Zadar, Croatia
RECRUITINGDept of Obstetrics and Gynecology
Helsingborg, Sweden
RECRUITINGproportion of women leaving the hospital within 12 hours after surgery complications.
Day sugery
Time frame: 12 hours
Hospitalization time
Time admitted
Time frame: 6 weeks
conversion rates
conversion to different surgival technique
Time frame: 12 hours
duration of the surgical procedure
from placement of Foley to last stich
Time frame: 12 hours
Intraoperative complications.
Complication
Time frame: 12 hours
postoperative complications,
Clavien Dindo
Time frame: 6 weeks
re-admission requiring hospitalization
Readminssion
Time frame: 6 weeks
Patient Reported Outcome Measures.
Short Female Sexual Function Index.
Time frame: 3 months postop
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