Comparison Between Classic Laparoscopic Dismembered Pyeloplasty and Insitu Spatulation with Pre-Dismembering Ureteropelvic Angle Suturing.

NCT06696508 | Completed DMC

• 1 other identifier: N-60-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Rationale One of the most challenging steps in laparoscopic pyeloplasty is the ureteral spatulation in addition to the apical suture placement. In this study we will describe a simplified technique to facilitate these tricky steps in order to avoid ureteral shortening, loss of orientation, to minimize ureteral manipulations and to avoid the early loss of pelvic tissue. Objectives: To describe our technique and assess its feasibility and its benefit to facilitate the ureteropelvic anastomosis in laparoscopic pyeloplasty. Study population , Sample size : Patients with UPJO indicated for laparoscopic pyeloplasty 50 patient Study Design: A Prospective Controlled Randomized Study. patients and methods : children less than ten years old with significant primary UPJ obstruction who were candidates for laparoscopic pyeloplasty were prospectively enrolled in this study. PUJ obstruction was discovered either incidentally on abdominal imaging or due to clinical presentation and complaints of the patients. Pre operative imaging was done for all patients in the form of ultrasonography, CT urography (CTU) and renal isotope scanning using Technetium-99m Diethylene Triamine Penta Acetic acid (Tc-99m DTPA). The indication for intervention was based either clinically on the patients' complaints or due to radiological signs of significant obstruction necessitating repair. Those who presented clinically were complaining of significant loin pain or repeated urinary tract infections. As regards the radiological indications of intervention, significant obstruction was deemed in cases of high grade or increase of hydronephrosis affecting the parenchymal thickness or echogenicity in repeated ultrasonography, marked hydronephrosis with delayed secretion of the intravenously injected contrast in CTUT or split renal function affection with obstructed pattern (t½ \>20 min with rising curve) in diuretic renal isotope scanning. Patients with previous abdominal surgery, concomitant secondary calculi or anatomically abnormal kidneys (as ectopic or horseshoe kidneys) were excluded from the study. The patients were randomized into one of two study groups: (Group A) for classic laparoscopic dismembered pyeloplasty and (Group B) for laparoscopic in situ dismembered pyeloplasty. Randomization was done using closed envelopes. The presence of crossing vessels did not contraindicate in situ spatulation and cases with aberrant vessels crossing the UPJ were randomized in both groups. All cases were done by the same laparoscopic surgeon in the pediatric urology department. Data was prospectively collected after the Institutional Review Board approval of the study protocol. Written informed consents were obtained from the patients' care givers before surgical intervention. Surgical Technique Under general anaesthesia, routine retrograde study and insertion of ureteric catheter just below the PUJ with a guide wire passing into the pelvis were done in both groups. In all cases, pyeloplasty was done through transperitoneal approach in lateral decubitus position via three 5 mm ports. In the classic approach: In brief, the PUJ was dismembered after proper dissection, the lateral aspect of the ureter was spatulated and the first stich was also placed in the spatulation angle from outside inwards. All these steps were done after the discontinuation of the ureter and the pelvis, losing the benefit of ureteric splinting and orientation. As regards the second group: After proper dissection of the PUJ, the anterior wall of the renal pelvis was incised. The incision continued downwards and laterally towards the PUJ and the lateral aspect of the ureter. In cases where crossing vessels were present, the pelvis with the PUJ and the uppermost part of the ureter were properly dissected from these vessels. This gave a wide room for pulling the pelvis upwards and gentle retraction of the crossing vessels allowing incision of the anterior wall of the pelvis and starting the spatulation of the PUJ. Spatulation could then continue to the upper ureter behind the properly dissected and retracted vessels. After complete spatulation and before dismembering the PUJ, we made benefit of splinting the ureter in place; a Maryland grasper opened the lumen of the ureter and the first stitch was precisely placed from outside inwards at the proper angle of the ureteric spatulation using 5/0 Vicryl sutures. The posterior wall of the PUJ and the pelvis was then dismembered and proper trimming and reduction of the pelvis were done if needed. The same stich was placed at the most dependent site at the inferior angle of the pelvis from inside outwards. In both groups: In cases with aberrant crossing vessels : All patients will underwent laparoscopic pyeloplasty with Insitu spatulation and pre-dismembering ureteropelvic angle suturing technique . Total operative time, stenting time, blood loss are all estimated. Patients will be followed after 3-6 months

Conditions

Pyeloplasty; Ureteropelvic Junction Obstruction

Keywords

pyeloplasty, laparoscopic pyeloplasty ,; dismembered pyeloplasty; ureteropelvic junction obstruction

Outcome Measures

Primary Outcomes (1)

• operative and post operative complication rate

  one year

Study Arms (2)

Insitu spatulation and pre-dismembering ureteropelvic angle suturing during laparoscopic pyeloplasty

EXPERIMENTAL

After proper dissection of the PUJ, the anterior wall of the renal pelvis was incised. The incision continued downwards and laterally towards the PUJ and the lateral aspect of the ureter. In cases where crossing vessels were present, the pelvis with the PUJ and the uppermost part of the ureter were properly dissected from these vessels. This gave a wide room for pulling the pelvis upwards and gentle retraction of the crossing vessels allowing incision of the anterior wall of the pelvis and starting the spatulation of the PUJ. Spatulation could then continue to the upper ureter behind the properly dissected and retracted vessels. After complete spatulation and before dismembering the PUJ, we made benefit of splinting the ureter in place; a Maryland grasper opened the lumen of the ureter and the first stitch was precisely placed from outside inwards at the proper angle of the ureteric spatulation using 5/0 Vicryl sutures. The posterior wall of the PUJ and the pelvis was then dismembered

Procedure: Insitu Spatulation with Pre-Dismembering Ureteropelvic Angle Suturing during laparoscopic pyeloplasty

the classic approach group

ACTIVE COMPARATOR

the PUJ was dismembered after proper dissection, the lateral aspect of the ureter was spatulated and the first stich was also placed in the spatulation angle from outside inwards. All these steps were done after the discontinuation of the ureter and the pelvis, losing the benefit of ureteric splinting and orientation

Procedure: Classic Laparoscopic Dismembered Pyeloplasty

Interventions

Insitu Spatulation with Pre-Dismembering Ureteropelvic Angle Suturing during laparoscopic pyeloplasty PROCEDURE

After proper dissection of the PUJ, the anterior wall of the renal pelvis was incised. The incision continued downwards and laterally towards the PUJ and the lateral aspect of the ureter. In cases where crossing vessels were present, the pelvis with the PUJ and the uppermost part of the ureter were properly dissected from these vessels. This gave a wide room for pulling the pelvis upwards and gentle retraction of the crossing vessels allowing incision of the anterior wall of the pelvis and starting the spatulation of the PUJ. Spatulation could then continue to the upper ureter behind the properly dissected and retracted vessels. After complete spatulation and before dismembering the PUJ, we made benefit of splinting the ureter in place; a Maryland grasper opened the lumen of the ureter and the first stitch was precisely placed from outside inwards at the proper angle of the ureteric spatulation using 5/0 Vicryl sutures. The posterior wall of the PUJ and the pelvis was then dismembered

Insitu spatulation and pre-dismembering ureteropelvic angle suturing during laparoscopic pyeloplasty

Classic Laparoscopic Dismembered Pyeloplasty PROCEDURE

the PUJ was dismembered after proper dissection, the lateral aspect of the ureter was spatulated and the first stich was also placed in the spatulation angle from outside inwards. All these steps were done after the discontinuation of the ureter and the pelvis, losing the benefit of ureteric splinting and orientation

the classic approach group

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients candidates for laparoscopic pyeloplasty aged from 3 to 60 years old.

You may not qualify if:

• Patients undergoing pyeloplasty other than dismembered type.
• Patients with a history of previous ipsilateral surgery
• Patients undergoing pyeloplasty other than dismembered type.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 02, Egypt

Location

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, urology department ,faculty of medicine , cairo university

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)