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Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction

T

Tanta University

Status

Completed

Conditions

Laparoscopic
Open
Obstruction
Primary Pelvi-Ureteric Junction
Dismembered Pyeloplasty

Treatments

Procedure: Open pyeloplasty
Procedure: Laparoscopic pyeloplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT06572371
36133/12/22

Details and patient eligibility

About

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

Full 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

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
  • Malignancy.
  • Refusal of written consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Laparoscopic pyeloplasty
Experimental group
Description:
Patients underwent laparoscopic pyeloplasty.
Treatment:
Procedure: Laparoscopic pyeloplasty
Open pyeloplasty
Active Comparator group
Description:
Patients underwent open pyeloplasty.
Treatment:
Procedure: Open pyeloplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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