Health TrialsbyHealthPanel

Ureterolysis in Laparoscopic Total Hysterectomy: Routine Approach

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Routine Ureterolysis

    Procedure/Surgery

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

  • Selective Ureterolysis

    Procedure/Surgery

    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.

Treatment groups

35,000 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

incidence of ureteric injury

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

Time frame
90 days

Secondary outcomes

1

Intraoperatively recognized ureteric injury

Intraoperatively recognized ureteric injury

Time frame
day 0
2

Postoperatively recognized ureteric injury

Postoperatively recognized ureteric injury

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ClinAmygate

Lead sponsor

Source ClinicalTrials.gov

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