Clinical trial NCT06526559: Barbed Versus PGA Sutures in Minimally Invasive Dismembered Pyeloplasty
Official title: The Evaluation of Barbed Sutures Versus Non-barbed Sutures in Minimally Invasive Dismembered Pyeloplasty. A Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pelvi-Ureteric Obstruction
Keywords: Pyeloplasty
Dismembered pyeloplasty
Laparoscopic pyeloplasty
Robot-assisted pyeloplasty
Barbed suture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Is it safe with similar post-operative outcomes?
2. Does it have any significant complications?
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time difference for suture completion
timeFrame: 12 months (Intra-operative data)
measure: Difference in complications rate
timeFrame: 18 months (Post-operative data)
measure: Drain output post-operative
timeFrame: 12 months (Early post-operative data)
Secondary outcomes:
measure: Difference in total operative time
timeFrame: 12 months (Intra-operative data)
measure: Difference in hospitalization time
timeFrame: 12 months (Early post-operative data)
measure: Failure rate
timeFrame: 18 months (Late post-operative data)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Kasr AlAiny Hospitals Urology Department 17B
Study officials:
affiliation: Professor - Urology Department - Reconstructive Urology Unit Cairo University
name: Waleed Ghoneima, MD
role: STUDY_CHAIR
affiliation: Assistant Professor - Urology Department - Oncology Unit - Cairo University
name: Ayman Kassem, MD
role: STUDY_DIRECTOR
affiliation: Lecturer - Urology Department - King Fahd Hospital - Cairo University
name: Mohammed Elghorably
role: STUDY_DIRECTOR
affiliation: Lecturer - Urology Department - King Fahd Hospital - Cairo University
name: Ahmed Sharawy, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.