Comparing barbed and PGA sutures in minimally invasive kidney surgery
The Evaluation of Barbed Sutures Versus Non-barbed Sutures in Minimally Invasive Dismembered Pyeloplasty. A Prospective Randomized Controlled Study.
This study is testing whether using barbed sutures instead of regular sutures during minimally invasive kidney surgery can lead to better recovery and fewer complications for both kids and adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06526559 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the safety and feasibility of using barbed sutures versus conventional PGA sutures in minimally invasive dismembered pyeloplasty for treating pelvi-ureteric obstruction. The study will assess post-operative outcomes, potential complications, and the ease of handling the sutures during surgery. By focusing on laparoscopic and robot-assisted techniques, the trial seeks to enhance patient satisfaction through reduced incision size and associated morbidity. The condition affects both pediatric and adult populations, making this research relevant for a significant number of patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a diagnosis of pelvi-ureteric junction obstruction requiring robotic or laparoscopic dismembered pyeloplasty.
Not a fit: Patients with contraindications for laparoscopic or robotic surgery, uncontrolled diabetes, morbid obesity, or a history of multiple major abdominal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction in minimally invasive kidney surgeries.
How similar studies have performed: Other studies have shown promising results with minimally invasive techniques for similar conditions, but the specific comparison of barbed versus PGA sutures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- Cairo University Kasr AlAiny Hospitals Urology Department 17B — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Makki, MSc, MRCS
- Email: mohamed.mohamed33511@postgrad.kasralainy.edu.eg
- Phone: +201112365033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.