Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty

NCT06526559 | Completed Phase 3 DMC FDA Device

• 1 other identifier: MD-439-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvi-Ureteric Obstruction

Keywords

Pyeloplasty; Dismembered pyeloplasty; Laparoscopic pyeloplasty; Robot-assisted pyeloplasty; Barbed suture

Outcome Measures

Primary Outcomes (3)

• Time difference for suture completion

  Mean difference of time taken in minutes between each group

  12 months (Intra-operative data)

• Difference in complications rate

  Mean difference in complications rate between both groups

  18 months (Post-operative data)

• Drain output post-operative

  Mean difference in total drain output between both groups

  12 months (Early post-operative data)

Secondary Outcomes (3)

• Difference in total operative time

  12 months (Intra-operative data)

• Difference in hospitalization time

  12 months (Early post-operative data)

• Failure rate

  18 months (Late post-operative data)

Study Arms (2)

Barbed suture group

EXPERIMENTAL

Pyeloplasty done using barbed absorbable sutures

Device: Barbed suture

PGA group

ACTIVE COMPARATOR

Pyeloplasty done using conventional PGA (Polyglactin) sutures

Device: PGA suture

Interventions

Barbed suture DEVICE

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

Also known as: V-Loc

Barbed suture group

PGA suture DEVICE

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

Also known as: Vicryl

PGA group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Kasr AlAiny Hospitals Urology Department 17B

Cairo, Egypt

Location

Related Publications (3)

• Shah HN, Nayyar R, Rajamahanty S, Hemal AK. Prospective evaluation of unidirectional barbed suture for various indications in surgeon-controlled robotic reconstructive urologic surgery: Wake Forest University experience. Int Urol Nephrol. 2012 Jun;44(3):775-85. doi: 10.1007/s11255-011-0075-y. Epub 2011 Nov 6.

  PMID: 22057590 RESULT

• Anand S, Jukic M, Krishnan N, Pogorelic Z. Barbed Versus Non-Barbed Suture for Pyeloplasty via the Minimally Invasive Approach: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech A. 2022 Oct;32(10):1056-1063. doi: 10.1089/lap.2021.0868. Epub 2022 May 12.

  PMID: 35549514 RESULT

• Giri V, Yadav SS, Tomar V, Jha AK, Garg A. Retrospective comparison of outcomes of laparoscopic pyeloplasty using barbed suture versus nonbarbed suture: A single-center experience. Urol Ann. 2019 Oct-Dec;11(4):410-413. doi: 10.4103/UA.UA_123_15.

  PMID: 31649463 RESULT

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Study Officials

• Waleed Ghoneima, MD

  Professor - Urology Department - Reconstructive Urology Unit Cairo University

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization is done using a web-based platform, group assignment will only be known to the surgeon (care provider). It would be concealed to the patient, investigator, and outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Specialist in Cairo University Hospital, Principal investigator, MD Candidate

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: November 22, 2023
• Primary Completion: December 30, 2024
• Study Completion: May 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publishing minimum after 18 months for whenever needed

Locations

EG (1)