Analysis of operating time and safety of laparoscopic pyeloplasty with or without TriSect rapide® in adult patients with ureteropelvic junction obstruction
| ISRCTN | ISRCTN15328718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15328718 |
- Submission date
- 07/08/2025
- Registration date
- 11/08/2025
- Last edited
- 11/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Laparoscopic pyeloplasty is a minimally invasive kidney surgery, an operation used to treat a blockage at the junction between the kidney and the ureter (the tube that drains urine from the kidney to the bladder). This study looks at whether using a special surgical instrument called TriSect rapide®, a multifunctional device that can cut and seal tissue, can make laparoscopic pyeloplasty faster and as safe as the standard method. The goal is to relieve this blockage and improve kidney function.
Who can participate?
Adult patients (≥18 years) diagnosed with ureteropelvic junction obstruction (UPJO) who are scheduled for elective laparoscopic pyeloplasty at the participating institution.
What does the study involve?
Participants were randomly assigned to one of two groups. One group had the surgery done with the TriSect rapide®. The other group had the surgery done with standard surgical instruments.
What are the possible benefits and risks of participating?
Possible Benefits:
Participants may experience shorter operative times and reduced anesthesia exposure due to the use of a multifunctional surgical instrument. The findings may help improve surgical efficiency and patient care for future patients with ureteropelvic junction obstruction.
Possible Risks:
Standard surgical risks such as bleeding, infection, or injury to surrounding structures. Device-specific risks may include technical failure or unintended tissue effects, though these are not expected to exceed the standard risk profile for laparoscopic pyeloplasty. Typical Anesthesia-related risks for procedures under general anesthesia. There is no anticipated increased risk due to participation in the study beyond what is expected for standard surgical treatment.
Where is the study run from?
The study was conducted with internal institutional resources. No external or commercial funding was received. The study is conducted at the Department of Urology, Hermann-Josef Hospital, Erkelenz, Germany.
When is the study starting and how long is it expected to run for?
June 2023 to July 2025
Who is funding the study?
Hermann-Josef Hospital Erkelenz, Germany
Essen University Hospital, Germany
Who is the main contact?
Dr. Christian Niedworok, Department of Urology, christian.niedworok@uni-due.de
Contact information
Public, Scientific, Principal Investigator
Urology Clinic of the Hermann-Josef Hospital
Tenholter Str. 43
Erkelenz
41812
Germany
 ORCID ID |
0000-0002-6796-9882 |
|---|---|
| Phone | +492431892747 |
| christian.niedworok@uni-due.de |
Study information
| Study design | Prospective randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Quality of life, Treatment, Safety, Efficacy |
| Participant information sheet | See study outputs table |
| Scientific title | Prospective randomized analysis of operating time and safety of laparoscopic pyeloplasty with or without TriSect rapide® in adult patients with ureteropelvic junction obstruction |
| Study objectives | This trial evaluated whether the TriSect rapide® could enhance surgical performance by reducing operative time without adversely affecting patient outcomes, quality of life, or the rate of perioperative complications, compared to standard laparoscopic instruments. |
| Ethics approval(s) |
Approved 31/07/2024, North Rhine Medical Association (Ärztekammer Nordrhein) (Tersteegenstr. 9, Dusseldorf, 40401, Germany; +4922143020; aerztekammer@aekno.de), ref: 2024105 |
| Health condition(s) or problem(s) studied | Ureteropelvic junction obstruction (UPJO) in adult patients undergoing laparoscopic pyeloplasty |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | TriSect rapide® (Olympus Surgical Technologies Europe) |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2023 |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 22 |
| Total final enrolment | 22 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 31/05/2025 |
Locations
Countries of recruitment
- Germany
Study participating centres
Essen
45147
Germany
Erkelenz
41812
Germany
Sponsor information
University/education
Hufelandstr. 55
Essen
45147
Germany
| Website | https://www.uni-due.de |
|---|---|
"ROR" |
https://ror.org/04mz5ra38 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be submitted for publication in a peer-reviewed scientific journal, regardless of whether they are positive, negative, or inconclusive. The findings will also be presented at relevant national and international urology conferences. Summaries of the results may be made available to participants upon request. In line with open science principles, anonymized data may be shared with other researchers upon reasonable request and following appropriate data protection procedures. |
| IPD sharing plan | The aggregated anonymized datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Christian Niedworok, christian.niedworok@uni-due.de, to qualified researchers upon reasonable request, subject to ethical approval and institutional agreements. Due to data protection regulations and the absence of explicit participant consent for public data sharing, individual participant data will not be made publicly available. |
Editorial Notes
08/08/2025: Study's existence confirmed by the North Rhine Medical Association (Ärztekammer Nordrhein).
