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

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

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

Study Overview

• Status: Completed
• Conditions: Obstruction; Laparoscopic; Open; Dismembered Pyeloplasty; Primary Pelvi-Ureteric Junction
• Intervention / Treatment: Procedure: Laparoscopic pyeloplasty; Procedure: Open pyeloplasty

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElGharbia
    • Tanta, ElGharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic pyeloplasty; Patients underwent laparoscopic pyeloplasty.	Procedure: Laparoscopic pyeloplasty; 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.
Active Comparator: Open pyeloplasty; Patients underwent open pyeloplasty.	Procedure: Open pyeloplasty; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of blood loss	Amount of blood loss was recorded.	Intraoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 24, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 24, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 36133/12/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data was available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No