An interventional study of Routine Ureterolysis and Selective Ureterolysis in Total Laparoscopic Hysterectomy, sponsored by ClinAmygate. Not yet recruiting at 1 site in Egypt. Open to female participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by ClinAmygate · Not applicable, Interventional, and Prevention
To evaluate whether routine ureterolysis during Total Laparoscopic Hysterectomy for benign gynecologic conditions affects operative efficiency and perioperative safety compared with a selective ureterolysis approach.
Hysterectomy is one of the most commonly performed major gynecological procedures worldwide, with approximately 600,000 procedures performed annually in the United States alone and similar rates observed globally when adjusted for population size.1 Over the past two decades, there has been a paradigm shift in surgical approach, with minimally invasive techniques, particularly total laparoscopic hysterectomy (TLH), increasingly replacing traditional open surgery.2 This transition has been driven by compelling evidence demonstrating significant advantages of the laparoscopic approach, including reduced postoperative pain, shorter hospital stays, faster return to normal activities, improved cosmetic outcomes, and lower overall morbidity compared to abdominal hysterectomy.2
Ureteric injury represents one of the most serious potential complications during TLH which occurs in 0.2 to 6 % of cases due to the close anatomical relation with the ureter, which is higher than abdominal hysterectomy in which ureteric injury occurs in 0.03 to 2 % of cases.3 Ureteric injury has potentially devastating consequences for patients including renal impairment, prolonged hospitalization, need for additional surgical interventions, and long-term morbidity.4
Ureterolysis during TLH helps to reduce the incidence of ureteric injury.5 Ureterolysis is infrequently practiced by gynecologists however, it is necessary during complex surgery.6 The American Association of Gynecologic Laparoscopists (AAGL) practice guidelines for laparoscopic hysterectomy state that "identification of the ureters should be undertaken when the anatomy is unclear or when risk factors for injury are present," but acknowledge that "some surgeons advocate routine ureterolysis for all laparoscopic hysterectomies.7
Surgeons who perform ureterolysis as a routine approach justify it due to :
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Women aged 35-70 years
Scheduled for TLH for benign indications:
Symptomatic fibroids, Abnormal uterine bleeding, Adenomyosis, Endometrial hyperplasia, Pelvic organ prolapse requiring hysterectomy, Chronic pelvic pain, Uterine size ≤16 weeks
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention Group: Routine Ureterolysis
Procedure: Routine Ureterolysis
Control group: selective Ureterolysis
Procedure: Selective Ureterolysis
for all cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record.
for selected cases of the group: After entering the pelvis and before uterine vessel ligation, routine bilateral ureterolysis will be performed. The retroperitoneal space will be opened by incising the peritoneum overlying the ureter, followed by careful blunt and sharp dissection to identify each ureter and trace its course from the pelvic brim toward the uterine artery and ureteric tunnel. Surrounding tissue will be dissected only to the extent necessary to obtain clear visualization and safe lateralization of the ureter before completing the hysterectomy. Excessive skeletonization, thermal spread, and disruption of the ureteral blood supply will be avoided. The procedure will be performed using a standardized technique and documented in the operative record.
Total operative duration
Total operative duration in minutes measured from skin incision to skin closure
Time frame: day 0
time needed for ureterolysis
Determine time needed for ureterolysis during TLH
Time frame: day 0
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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