Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty

January 2, 2026 updated by: Mohamed Ahmed Mohamed Fakhry Makki, Cairo University

The Evaluation of Barbed Sutures Versus Non-barbed Sutures in Minimally Invasive Dismembered Pyeloplasty. A Prospective Randomized Controlled Study.

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Minimally invasive surgeries for pelviureteric junction obstruction have become more popular in the past decade than open surgery. This is to decrease the morbidity for patients and attain better patient satisfaction especially for having a significantly smaller incisions compared to open flank and midline abdominal incisions.

Minimally invasive surgery is a term used to describe surgeries that would spare the patient a long incision and hence spares him also the pain and risk of wound infection associated with it. In this study the investigators will focus only on laparoscopy and robot-assisted surgeries.

Pelviureteric junction obstruction is a disease that is not uncommon with an incidence of 1 in 1000-1500. Although usually it is diagnosed in the pediatric population, it is not uncommon in adults. PUJO (Pelviureteric junction obstruction) could have it's impact on the patient's quality of life as if it is not treated it could decrease the split glomerular filtration rate due to impaired drainage. It also could present with secondary renal stones, pain, recurrent upper urinary tract infection, fever and urosepsis.

Management of PUJO (Pelviureteric junction obstruction) starts with the proper assessment of the patient regarding his age and careful history taking and physical examination, evaluation of laboratory investigations such as urine culture and sensitivity, serum creatinine, total leucocytic count. Also, evaluation of the pelviabdominal ultrasound, intravenous pyelography, and diuretic renogram.

Treatment of PUJO (Pelviureteric junction obstruction) ranges from active surveillance, endopyelotomy and ureteral stenting, and pyeloplasty whether it is open, laparoscopic or robot-assisted.

Traditionally, absorbable polyglactin sutures is used for dismembered pyeloplasty. Yet recently barbed sutures have gained popularity within urologists especially in minimally invasive surgeries.

Barbed knotless uni-directional sutures have the benefit of being knotless and evenly distributes tension so there is no need for the assistant to follow the surgeon and stretch the suture, this significantly decreases the operative time and frees the assistant's port to be able to do other steps.

Barbed sutures have been well established in other surgical fields such as bariatric surgery, gynecology, and skin closure previously, and recently it has been populated in the urological community especially in the vesicourethral anastomosis in Radical prostatectomy.

Sparse yet promising articles have been published regarding the use of barbed sutures in pyeloplasty which could change the way surgeons approach the disease.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Kasr AlAiny Hospitals Urology Department 17B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 to 60 undergoing robotic or laparoscopic dismembered pyeloplasty
  • History of dietls' crisis (Fever, pain) in a pelviureteric junction obstructed kidney
  • Decrease in glomerular filtration rate in a pelviureteric junction obstructed kidney

Exclusion Criteria:

  • Contraindications for laparoscopy or robotic surgery as pulmonary obstructive or restrictive disease, and poor cardiovascular fitness
  • Uncontrolled diabetes mellitus
  • Morbid obesity
  • History of multiple major abdominal surgeries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Barbed suture group
Pyeloplasty done using barbed absorbable sutures
Device: Barbed suture
Use of two absorbable barbed sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty
Other Names:
  • V-Loc
Active Comparator: PGA group
Pyeloplasty done using conventional PGA (Polyglactin) sutures
Device: PGA suture
Use of two absorbable polyglactin sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty
Other Names:
  • Vicryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time difference for suture completion
Time Frame: 12 months (Intra-operative data)
Mean difference of time taken in minutes between each group
12 months (Intra-operative data)
Difference in complications rate
Time Frame: 18 months (Post-operative data)
Mean difference in complications rate between both groups
18 months (Post-operative data)
Drain output post-operative
Time Frame: 12 months (Early post-operative data)
Mean difference in total drain output between both groups
12 months (Early post-operative data)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in total operative time
Time Frame: 12 months (Intra-operative data)
Mean difference in total operative time post-operative
12 months (Intra-operative data)
Difference in hospitalization time
Time Frame: 12 months (Early post-operative data)
Mean difference in hospitalization time
12 months (Early post-operative data)
Failure rate
Time Frame: 18 months (Late post-operative data)
Difference in number of patients who needed redo pyeloplasty or any auxiliary procedures
18 months (Late post-operative data)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Waleed Ghoneima, MD, Professor - Urology Department - Reconstructive Urology Unit Cairo University
  • Study Director: Ayman Kassem, MD, Assistant Professor - Urology Department - Oncology Unit - Cairo University
  • Study Director: Mohammed Elghorably, Lecturer - Urology Department - King Fahd Hospital - Cairo University
  • Study Director: Ahmed Sharawy, MD, Lecturer - Urology Department - King Fahd Hospital - Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-439-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

After publishing minimum after 18 months for whenever needed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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