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

NCT ID: NCT06572371

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-10-01

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic pyeloplasty

Patients underwent laparoscopic pyeloplasty.

Group Type: EXPERIMENTAL

Laparoscopic pyeloplasty

Intervention Type: 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

Patients underwent open pyeloplasty.

Group Type: ACTIVE_COMPARATOR

Open pyeloplasty

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mina Soliman Messiha Georgy

Resident of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, ElGharbia, Egypt

Countries

Egypt

Other Identifiers

36133/12/22

Identifier Type: -

Identifier Source: org_study_id