At a glance
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Hysterectomy for Benign Gynaecological Disease by Natural Orifice Transluminal Endoscopic Surgery or Laparoscopy
In Brief
A clinical study evaluating vNOTES hysterectomy and LSC hysterectomy for Uterine Diseases. Completed, enrolled 70 participants across 1 site.
Detailed Summary
Objective: To randomly compare hysterectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy uterus in women with benign gynecological pathology. Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial. Study population: All women aged 18 to 70 years regardless of parity with a non-prolapsed uterus and a benign indication for hysterectomy. Primary study outcome parameters: successful removal of the uterus by the intended technique. Secondary outcomes: the proportion of women admitted to the in-hospital ward; postoperative pain scores; the total amount of analgesics used; postoperative infection; per- or postoperative complications; hospital readmission rates; duration of the surgical procedure; incidence and intensity of dyspareunia; sexual wellbeing; health-related quality of life; costs.
Study Details
Timeline
Interventions
Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy
Surgical removal of the uterus by transabdominal laparoscopy