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

NCT06572371 | Completed

• 1 other identifier: 36133/12/22
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Open; Laparoscopic; Dismembered Pyeloplasty; Primary Pelvi-Ureteric Junction; Obstruction

Outcome Measures

Primary Outcomes (1)

• Amount of blood loss

  Amount of blood loss was recorded.

  Intraoperatively

Secondary Outcomes (2)

• Etiology of obstruction

  Intraoperatively

• Complications

  24 hours postoperatively

Study Arms (2)

Laparoscopic pyeloplasty

EXPERIMENTAL

Patients underwent laparoscopic pyeloplasty.

Procedure: Laparoscopic pyeloplasty

Open pyeloplasty

ACTIVE COMPARATOR

Patients underwent open pyeloplasty.

Procedure: Open pyeloplasty

Interventions

Laparoscopic pyeloplasty PROCEDURE

The first trocar was inserted under vision through the same supraumbilical incision and the intraperitoneal cavity was inspected The second 5 mm trocar was placed in the midclavicular line 2 inches below the costal margin. The third 10 mm trocar was placed lateral to the rectus muscle at the level of the anterior superior iliac spine. In right-sided pyeloplasty, a fourth trocar was inserted below the xiphistemum for liver retraction. Incision of the line of Toldt and mobilization of the colon was the first step of the transperitoneal approach. A 4/0 polysorbe stay suture was taken in the lateral aspect of the ureter distal to uretero-pelvic junction obstruction to identify the correct orientation after dismembering the ureter. A full thickness anastomosis was started from the angle of V shape spatulation to the lower pole of the renal pelvis.

Laparoscopic pyeloplasty

Open pyeloplasty PROCEDURE

A flank incision with the patient in lateral position was undertaken in open pyeloplasty. After accessing the retro- peritoneum, the ureter was identified and traced cranially till the PUJ segment. Traction sutures was placed on the renal pelvis followed by excision of the narrowing segment. The ureter was spatulated by approximately 2 cm and a reduction pyeloplasty was performed, where necessary. Anastomosis was undertaken using vicryl 4-0 sutures. The primary anastomotic site was sutured in interrupted fashion followed by a continuous running suture of the posterior wall. Next, antegrade DJ stenting was performed and the anterior wall was anastomosed. After haemostatic control a 22 Fr drain was placed in the surgical bed.

Open pyeloplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 27, 2024
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data was available upon a reasonable request from the corresponding author.

Locations

EG (1)