Analysis of operating time and safety of laparoscopic pyeloplasty with or without TriSect rapide® in adult patients with ureteropelvic junction obstruction

Prospective randomized analysis of operating time and safety of laparoscopic pyeloplasty with or without TriSect rapide® in adult patients with ureteropelvic junction obstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15328718

Enrollment

Registered

2025-08-11

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteropelvic junction obstruction (UPJO) in adult patients undergoing laparoscopic pyeloplasty Urological and Genital Diseases

Interventions

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 patient

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Total operative time (minutes) measured using data collected from the surgical record during the operation (single surgical session) from initial incision to final skin closure	—

Secondary

Measure	Time frame
1. Preparation time (minutes) measured using data collected from the surgical record during the operation, the time from initial trocar insertion to the beginning of the anastomosis 2. Anesthesia duration (minutes) measured using data collected from the surgical record, from induction of anesthesia to extubation 3. Intra- and perioperative complications measured using data collected from case report forms intraoperatively and during hospital stay, graded using the Clavien-Dindo classification 4. Health-related quality of life (HRQoL) measured using the RAND 36-Item Short Form Survey Instrument (SF-36) or other validated PROM preoperatively and 6 weeks postoperatively	—

Measure

Time frame

1. Preparation time (minutes) measured using data collected from the surgical record during the operation, the time from initial trocar insertion to the beginning of the anastomosis 2. Anesthesia duration (minutes) measured using data collected from the surgical record, from induction of anesthesia to extubation 3. Intra- and perioperative complications measured using data collected from case report forms intraoperatively and during hospital stay, graded using the Clavien-Dindo classification 4. Health-related quality of life (HRQoL) measured using the RAND 36-Item Short Form Survey Instrument (SF-36) or other validated PROM preoperatively and 6 weeks postoperatively

—

Countries

Germany

Contacts

Public ContactChristian Niedworok

christian.niedworok@uni-due.de+492431892747

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026