Kasr Alaini gynecology and obstetrics hospital
Cairo, Cairo Governorate, 11472, Egypt
NCT Number: NCT07774871
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.
Trial opening soon.
Get Notified35 year–70 year
Female
Interventional
Not applicable
Cairo, Cairo Governorate, 11472, Egypt
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
Time frame: day 0
Total operative duration in minutes measured from skin incision to skin closure
Time frame: day 0
Determine time needed for ureterolysis during TLH
Contact information is provided by the study sponsor or research team.
ClinAmygate
Other
Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial of Operative Efficiency and Perioperative Safety
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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