Routine Versus Selective Ureterolysis During Total Laparoscopic Hysterectomy for Benign Conditions

NCT07774871 | Not Yet Recruiting

• 1 other identifier: PR-MD-238-2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Total operative duration

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

  day 0

Secondary Outcomes (1)

• time needed for ureterolysis

  day 0

Study Arms (2)

Routine Ureterolysis

EXPERIMENTAL

Intervention Group: Routine Ureterolysis

Procedure: Routine Ureterolysis

Selective Ureterolysis

ACTIVE COMPARATOR

Control group: selective Ureterolysis

Procedure: Selective Ureterolysis

Interventions

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.

Routine Ureterolysis

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.

Selective Ureterolysis

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ClinAmygate: lead

Study Sites (1)

Kasr Alaini gynecology and obstetrics hospital

Cairo, Cairo Governorate, 11472, Egypt

Location

Central Study Contacts

Mostfa MA Saad, MSc

CONTACT

+201006744717; mostafa.saad.gyn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative outcome assessors will be blinded to treatment allocation. Because of the nature of the surgical interventions, the operating surgeons cannot be blinded. Data analysts will remain blinded to group allocation, with the intervention groups coded and their identities concealed until the primary analysis has been completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Randomized controlled parallel study

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 19, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 28, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)