Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-70
SponsorClinAmygate

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Previous pelvic radiation

Known ureteric abnormalities or pathology

Severe cardiopulmonary disease precluding laparoscopy

Inability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Routine Ureterolysis

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Routine UreterolysisExperimental treatment 1 intervention
Group B: Selective UreterolysisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total operative duration

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

Time frame
day 0

Secondary outcomes

1

time needed for ureterolysis

Determine time needed for ureterolysis during TLH

Time frame
day 0

Other outcomes

Sponsors and contacts

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ClinAmygate

Lead sponsor

Cairo University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: