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More info
You can access this
clinical trial
if you have
Uterine Diseases
and you are
between 18 and 70
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Procedure: vNOTES hysterectomy
  • Procedure: LSC hysterectomy

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02631837. The sponsor of the trial is Imelda Hospital, Bonheiden and it is looking for 70 volunteers for the current phase.
Official trial title:
Hysterectomy for Benign Gynaecological Disease by Natural Orifice Transluminal Endoscopic Surgery or Laparoscopy