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NCT Number: NCT07774871

Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions

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.

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Key information

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alaini gynecology and obstetrics hospital

Cairo, Cairo Governorate, 11472, Egypt

Location contact

Mostafa MA Saad, MSc

CONTACT

[email protected]

+201006744717

About this study

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 :

  • The additional operative time (10-15 minutes) is justified by improved safety.8
  • When performed correctly, ureterolysis does not significantly increase risk of direct injury.8
  • The technique preserves periureteric blood supply when proper tissue planes are followed.8
  • Routine practice ensures surgical proficiency.8
  • Patient outcomes are improved when injuries are prevented rather than managed after they occur.8 In this study we aim to compare between routine approach and selective approach for ureterolysis during laparoscopic hysterectomy

Who can participate

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

  • Previous pelvic radiation
  • Known ureteric abnormalities or pathology
  • Severe cardiopulmonary disease precluding laparoscopy
  • Inability to provide informed consent
  • Known retroperitoneal pathology
  • Emergency surgery
  • Uterine size > 16 weeks

Treatment and study plan

Routine Ureterolysis

Procedure

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.

Selective Ureterolysis

Procedure

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.

Primary outcomes

  1. Total operative duration

    Time frame: day 0

    Total operative duration in minutes measured from skin incision to skin closure

Secondary outcomes

  1. time needed for ureterolysis

    Time frame: day 0

    Determine time needed for ureterolysis during TLH

Study contacts

Contact information is provided by the study sponsor or research team.

Mostfa MA Saad, MSc

CONTACT

[email protected]

+201006744717

Sponsors and collaborators

Lead sponsor

ClinAmygate

Other

Registry information

Official study title

Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial of Operative Efficiency and Perioperative Safety

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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