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Ureterolysis in Laparoscopic Total Hysterectomy: Routine Approach

Study acronym: ULTRA
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study description revisedv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized controlled trial will compare routine bilateral ureterolysis with selective ureterolysis during total laparoscopic hysterectomy for benign gynecological conditions. Participants will be allocated to either routine ureter identification and dissection before uterine vessel ligation or selective ureterolysis performed only when predefined intraoperative safety triggers are present. The primary outcome will be the incidence of recognized and unrecognized ureteric injury, while secondary outcomes will include operative time, blood loss, other perioperative complications, conversion to laparotomy, length of hospital stay, and postoperative recovery.
Trial Details
NCT Number NCT07774858
Lead Sponsor ClinAmygate
Conditions
(from sponsor)		 Hysterectomy, Laparoscopic Surgery
Enrollment 35,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov