Pelvi-Ureteric ObstructionPhase 3NCT06526559
Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty
A Phase 3 study testing Barbed suture and PGA suture in people with Pelvi-Ureteric Obstruction, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pelvi-Ureteric Obstruction
- What is being tested?
- Barbed suture and PGA suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2023to 30 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Is it safe with similar post-operative outcomes?
- Does it have any significant complications?
- Is it easier to handle intra-operatively?
Read the 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.
- Conditions
- Pelvi-Ureteric Obstruction
- Being tested
- Barbed suture, PGA suture
- Keywords
- Pyeloplasty, Dismembered pyeloplasty, Laparoscopic pyeloplasty, Robot-assisted pyeloplasty, Barbed suture
- Medical subject headings
- Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barbed sutureDevice
Also called V-Loc
Use of two absorbable barbed sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty
PGA sutureDevice
Also called Vicryl
Use of two absorbable polyglactin sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty
| Study group | Role | What they receive |
|---|---|---|
| Barbed suture group | Experimental | Pyeloplasty done using barbed absorbable sutures Receives: Device: Barbed suture |
| PGA group | Active comparator | Pyeloplasty done using conventional PGA (Polyglactin) sutures Receives: Device: PGA suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time difference for suture completion
Mean difference of time taken in minutes between each group
Measured: 12 months (Intra-operative data)
Difference in complications rate
Mean difference in complications rate between both groups
Measured: 18 months (Post-operative data)
Drain output post-operative
Mean difference in total drain output between both groups
Measured: 12 months (Early post-operative data)
Secondary outcomes (3)
Difference in total operative time
Mean difference in total operative time post-operative
Measured: 12 months (Intra-operative data)
Difference in hospitalization time
Mean difference in hospitalization time
Measured: 12 months (Early post-operative data)
Failure rate
Difference in number of patients who needed redo pyeloplasty or any auxiliary procedures
Measured: 18 months (Late post-operative data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start22 Nov 2023
- Primary completion30 Dec 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvi-Ureteric ObstructionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Fakhry Makki, Cairo University
- Investigators
- Waleed Ghoneima, MD, Study chair, Professor - Urology Department - Reconstructive Urology Unit Cairo UniversityAyman Kassem, MD, Study director, Assistant Professor - Urology Department - Oncology Unit - Cairo UniversityMohammed Elghorably, Study director, Lecturer - Urology Department - King Fahd Hospital - Cairo UniversityAhmed Sharawy, MD, Study director, Lecturer - Urology Department - King Fahd Hospital - Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526559
- Sponsor's protocol ID
- MD-439-2023
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 22057590Anand 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.
PubMed 35549514Giri 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.
PubMed 31649463
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Barbed Sutures Versus Non-barbed Sutures in Minimally Invasive Dismembered Pyeloplasty. A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06526559
- Acronym / sponsor ID
- MD-439-2023
- Conditions
- Pelvi-Ureteric Obstruction
- Keywords
- Pyeloplasty, Dismembered pyeloplasty, Laparoscopic pyeloplasty, Robot-assisted pyeloplasty, Barbed suture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it safe with similar post-operative outcomes?
- Does it have any significant complications?
- Is it easier to handle intra-operatively?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barbed suture group | Experimental | Device: Barbed suturePyeloplasty done using barbed absorbable sutures |
| PGA group | Active comparator | Device: PGA suturePyeloplasty done using conventional PGA (Polyglactin) sutures |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barbed sutureAlso: V-LocUse of two absorbable barbed sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty | Device | Barbed suture group |
| PGA sutureAlso: VicrylUse of two absorbable polyglactin sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty | Device | PGA group |
Primary outcome
Time difference for suture completion
Time frame: 12 months (Intra-operative data)
Mean difference of time taken in minutes between each group
Difference in complications rate
Time frame: 18 months (Post-operative data)
Mean difference in complications rate between both groups
Drain output post-operative
Time frame: 12 months (Early post-operative data)
Mean difference in total drain output between both groups
3 secondary outcomes
Difference in total operative time
Time frame: 12 months (Intra-operative data)
Difference in hospitalization time
Time frame: 12 months (Early post-operative data)
Failure rate
Time frame: 18 months (Late post-operative data)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Results publication: PubMed 22057590Shah 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.
- Results publication: PubMed 35549514Anand 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.
- Results publication: PubMed 31649463Giri 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Ghoneima, MD study chair
Professor - Urology Department - Reconstructive Urology Unit Cairo University
Ayman Kassem, MD study director
Assistant Professor - Urology Department - Oncology Unit - Cairo University
Mohammed Elghorably study director
Lecturer - Urology Department - King Fahd Hospital - Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Barbed suture and PGA suture in people with Pelvi-Ureteric Obstruction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time difference for suture completion (time frame: 12 months (Intra-operative data)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526559, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.