Clinical trial NCT06572371: Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction
Official title: A Prospective Randomized Study Comparing Open Versus Laparoscopic Dismembered Pyeloplasty Among Adult Patients With Primary Pelvi-Ureteric Junction Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open
Laparoscopic
Dismembered Pyeloplasty
Primary Pelvi-Ureteric Junction
Obstruction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.
* Malignancy.
* Refusal of written consent.

Primary outcomes:
measure: Amount of blood loss
timeFrame: Intraoperatively
Secondary outcomes:
measure: Etiology of obstruction
timeFrame: Intraoperatively
measure: Complications
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: ElGharbia
Study officials:
References: