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Clinical Trials/NCT06572371
NCT06572371
Completed
Not Applicable

A Prospective Randomized Study Comparing Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction

Tanta University1 site in 1 country34 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Open
Sponsor
Tanta University
Enrollment
34
Locations
1
Primary Endpoint
Amount of blood loss
Status
Completed
Last Updated
last year

Overview

Brief Summary

To prospectively compare the perioperative, morphological and functional outcomes on short and medium term between laparoscopic (LP) and open pyeloplasty (OP) patients.

Detailed Description

Pelvi-ureteric junction obstruction (PUJO) is defined as a functionally significant impairment of the flow of urine from the kidney's renal pelvis into the proximal ureter. Open pyeloplasty (OP) has been the gold standard for PUJO repair since the first successful reconstruction of an obstructed PUJO was accomplished in 1892, and achieves success rates exceeding 90%. Various open surgical techniques have been described based on the cause, location, and length of the PUJO. The most popular repair is the Anderson-Hynes dismembered pyeloplasty, which has universal application and is accepted as the gold standard of treatment. Now, Laparoscopic dismembered pyeloplasty represents a minimally invasive alternative of gold standard open Anderson- Hynes technique that has a comparable successful outcome with open pyeloplasty while avoiding its co-morbidities. It is also better than endopylotomy as it deals effectively with the crossing vessel

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
October 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mina Soliman Messiha Georgy

Resident of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

Eligibility Criteria

Inclusion Criteria

  • All adult patients (above 18 years old) with primary pelvi-ureteric junction obstruction indicated for active intervention as
  • Symptoms such as recurrent flank pain, recurrent urinary tract infection and rarely hypertension.
  • Breakthrough urinary tract infections while on prophylactic antibiotics.
  • Increasing renal antero-posterior diameter, or decreasing renal parenchymal thickness by ultrasound.
  • Low or decreasing differential renal function, but above 10%.

Exclusion Criteria

  • Patients having poor ipsilateral renal function \< 10%.
  • Patients with previous pelvi-ureteric junction obstruction repair.
  • Associated renal stones.
  • Patients unfit for surgery according to American Society of Anesthesiologists classification.
  • Contraindications for laparoscopy as (marked obesity, large ventral hernias, gross coagulopathy, abdominal wall sepsis, vertebral deformities...).
  • Pediatric patients.
  • Pregnant women.
  • Vesicoureteral reflux.
  • Congenital renal anomalies as (horse- shoe kidney, pelvic kidney, mal- rotated kidney ...).
  • Single functioning kidney.

Outcomes

Primary Outcomes

Amount of blood loss

Time Frame: Intraoperatively

Amount of blood loss was recorded.

Secondary Outcomes

  • Complications(24 hours postoperatively)
  • Etiology of obstruction(Intraoperatively)

Study Sites (1)

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