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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barbed suture group | Experimental | Pyeloplasty done using barbed absorbable sutures |
|
| PGA group | Active Comparator | Pyeloplasty done using conventional PGA (Polyglactin) sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barbed suture | Device | Use of two absorbable barbed sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in total operative time | Mean difference in total operative time post-operative | 12 months (Intra-operative data) |
| Difference in hospitalization time | Mean difference in hospitalization time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Kasr AlAiny Hospitals Urology Department 17B | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22057590 | Result | 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. | |
| 35549514 | Result |
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After publishing minimum after 18 months for whenever needed
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| ID | Term |
|---|---|
| C537373 | Multicystic renal dysplasia, bilateral |
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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
|
| PGA suture | Device | Use of two absorbable polyglactin sutures for each arm in the ureteropelvic anastomosis in minimally invasive dismembered pyeloplasty |
|
|
| 12 months (Early post-operative data) |
| Failure rate | Difference in number of patients who needed redo pyeloplasty or any auxiliary procedures | 18 months (Late post-operative data) |
| 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. |
| 31649463 | 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. |