Skip to main content
OpenTrials
Completed

NCT Number: NCT06572371

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open Bites and Stings Chemically-Induced Disorders Dismembered Pyeloplasty Laparoscopic Obstruction Poisoning Primary Pelvi-Ureteric Junction Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, ElGharbia, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Amount of blood loss

    Time frame: Intraoperatively

    Amount of blood loss was recorded.

Secondary outcomes

  1. Etiology of obstruction

    Time frame: Intraoperatively

    Etiology of obstruction such as adynamic segment, crossing vessel, stenotic segment, adhesions, and abnormal gonadal vein were recorded.

  2. Complications

    Time frame: 24 hours postoperatively

    Complications was recorded such as wound complications, loin or abdominal pain, fever, chills and rigor, change of color of urine, dysuria.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.