Prospective randomized analysis of operating time and safety of laparoscopic pyeloplasty with or without TriSect rapide® in adult patients with ureteropelvic junction obstruction
Ureteropelvic junction obstruction (UPJO) in adult patients undergoing laparoscopic pyeloplasty
This was a prospective, randomized clinical trial conducted to evaluate the operative time and safety of laparoscopic pyeloplasty with or without the use of the TriSect rapide® device in adult patients with ureteropelvic junction obstruction. Patients were randomly assigned to either the intervention group (TriSect rapide®) or the control group (standard instruments). Randomisation was performed 1:1 using a computer-generated randomisation list with a block size of 4. Group allocation was conducted by an independent individual using sequentially numbered, opaque, sealed envelopes. Preoperative and postoperative parameters, surgical duration, complications, and quality of life outcomes were assessed and compared between the two groups. Experimental group: Laparoscopic pyeloplasty using the multifunctional energy device TriSect rapide® for dissection and hemostasis. Control group: Laparoscopic pyeloplasty using standard bipolar and monopolar instruments for dissection and hemostasis.
1. Confirmed UPJ obstruction 2. Aged between 18 and 80 years 3. ASA-performance status 1-3 4. Eligibility for surgical intervention 5. Life expectancy > 12 months 6. Ability to provide written informed consent and willingness to comply with scheduled follow-up visits
1. Unable or unwilling to provide informed consent 2. Pregnant patients 3. Patients under the age of 18 or over 80 4. Unfit or unwilling to undergo surgery 5. Surgery involving the retroperitoneum, ureter or kidney 6. Anticipated noncompliance with follow-up requirements 7. Chronic substance abuse 8. Insurmountable language barriers 9. Concurrent participation in another clinical study