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Ureterolysis in Laparoscopic Total Hysterectomy: Routine Approach
Sponsor: ClinAmygate
Summary
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.
Official title: Ureterolysis in Laparoscopic Total Hysterectomy: Routine Approach; A Parallel Multicenter Randomized Controlled Trial. (ULTRA) Mega Trial
Key Details
Gender
FEMALE
Age Range
35 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
35000
Start Date
2026-09-16
Completion Date
2033-03-01
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Routine Ureterolysis
Bilateral ureterolysis is systematically performed before uterine vessel ligation to identify and protect both ureters.
Selective Ureterolysis
Ureterolysis is performed only when predefined intraoperative indications are present, such as distorted anatomy, poor ureteric visualization, dense adhesions, endometriosis, active bleeding, or concern regarding ureteric safety.
Locations (1)
Obstetrics & Gynaecology Department Faculty of Medicine, Cairo University | Kasr Al Ainy Hospital
Cairo, Cairo Governorate, Egypt