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Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty

NCT06526559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-05

No results posted yet for this study

Summary

The main goals of this trial is to study the feasibility and safety of using barbed sutures compared to the conventional PGA (Polyglactin) sutures in minimally invasive dismembered pyeloplasty. The main questions in using barbed sutures would be:

1. Is it safe with similar post-operative outcomes?
2. Does it have any significant complications?
3. Is it easier to handle intra-operatively?

Conditions

  • Pelvi-Ureteric Obstruction

Interventions

DEVICE

Barbed suture

Use of two absorbable barbed sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty

DEVICE

PGA suture

Use of two absorbable polyglactin sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Waleed Ghoneima, MD · Professor - Urology Department - Reconstructive Urology Unit Cairo University

  • Ayman Kassem, MD · Assistant Professor - Urology Department - Oncology Unit - Cairo University

  • Mohammed Elghorably · Lecturer - Urology Department - King Fahd Hospital - Cairo University

  • Ahmed Sharawy, MD · Lecturer - Urology Department - King Fahd Hospital - Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2024-12-30
Completion
2025-05-30
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526559 on ClinicalTrials.gov