NCT07774858

Brief Summary

This randomized controlled trial will compare routine bilateral ureterolysis with selective ureterolysis during total laparoscopic hysterectomy for benign gynecological conditions. Participants will be allocated to either routine ureter identification and dissection before uterine vessel ligation or selective ureterolysis performed only when predefined intraoperative safety triggers are present. The primary outcome will be the incidence of recognized and unrecognized ureteric injury, while secondary outcomes will include operative time, blood loss, other perioperative complications, conversion to laparotomy, length of hospital stay, and postoperative recovery.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,000

participants targeted

Target at P75+ for not_applicable

Timeline
78mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Mar 2033

First Submitted

Initial submission to the registry

August 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

September 16, 2026

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

6.2 years

First QC Date

August 16, 2026

Last Update Submit

August 24, 2026

Conditions

HysterectomyLaparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • incidence of ureteric injury

    The proportion of participants experiencing at least one confirmed ureteric injury from randomization until 90 days after surgery.

    90 days

Secondary Outcomes (2)

  • Intraoperatively recognized ureteric injury

    day 0

  • Postoperatively recognized ureteric injury

    90 days

Study Arms (2)

Routine Ureterolysis

EXPERIMENTAL

Bilateral ureterolysis is systematically performed before uterine vessel ligation to identify and protect both ureters.

Procedure: Routine Ureterolysis

Selective Ureterolysis

ACTIVE COMPARATOR

Ureterolysis is performed only when predefined intraoperative indications are present, such as distorted anatomy, poor ureteric visualization, dense adhesions, endometriosis, active bleeding, or concern regarding ureteric safety.

Procedure: Selective Ureterolysis

Interventions

Routine UreterolysisPROCEDURE

Bilateral ureterolysis is systematically performed before uterine vessel ligation to identify and protect both ureters.

Routine Ureterolysis
Selective UreterolysisPROCEDURE

Ureterolysis is performed only when predefined intraoperative indications are present, such as distorted anatomy, poor ureteric visualization, dense adhesions, endometriosis, active bleeding, or concern regarding ureteric safety.

Selective Ureterolysis

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged ≥18 years.
  • Scheduled for total laparoscopic hysterectomy for a benign gynecological condition.
  • Able and willing to provide written informed consent.
  • Considered medically suitable for laparoscopic surgery.

You may not qualify if:

  • Suspected or confirmed gynecological malignancy.
  • Known congenital urinary tract anomaly or pre-existing ureteric obstruction, stricture, fistula, or injury.
  • Previous ureteric reconstruction or current ureteric stent.
  • Planned concomitant urological surgery involving the ureter or bladder.
  • Emergency hysterectomy.
  • Planned subtotal, vaginal, or abdominal hysterectomy.
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics & Gynaecology Department Faculty of Medicine, Cairo University | Kasr Al Ainy Hospital

Cairo, Cairo Governorate, 11472, Egypt

Location

Study Officials

  • Khaled AA ElSetohy, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled AA ElSetohy, MD

CONTACT

01110006946kelsetohy@kasralainy.edu.eg

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. Operating surgeons cannot be blinded because of the nature of the surgical intervention. Group allocation will be coded, and data analysts will remain blinded until the primary statistical analysis has been completed.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Parallel Multicenter Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 19, 2026

Study Start

September 16, 2026

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

March 1, 2033

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations

EG(1)