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

Not Applicable

Completed

• Conditions: Obstruction; Laparoscopic; Dismembered Pyeloplasty; Open; Primary Pelvi-Ureteric Junction
• Interventions: Procedure: Open pyeloplasty; Procedure: Laparoscopic pyeloplasty

• Registration Number: NCT06572371
• Lead Sponsor: Tanta University

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

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-24
• Last Update Submitted: 2024-08-24
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open pyeloplasty	Open pyeloplasty	Patients underwent open pyeloplasty.
Laparoscopic pyeloplasty	Laparoscopic pyeloplasty	Patients underwent laparoscopic pyeloplasty.

Primary Outcome Measures

Name	Time	Method
Amount of blood loss	Intraoperatively	Amount of blood loss was recorded.

Secondary Outcome Measures

Name	Time	Method
Complications	24 hours postoperatively	Complications was recorded such as wound complications, loin or abdominal pain, fever, chills and rigor, change of color of urine, dysuria.
Etiology of obstruction	Intraoperatively	Etiology of obstruction such as adynamic segment, crossing vessel, stenotic segment, adhesions, and abnormal gonadal vein were recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, ElGharbia, Egypt