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Secure Evaluation of Anastomotic Leakage in Robotic Prostatectomy: a prospective, randomized, interventional comparison

Secure Evaluation of Anastomotic Leakage in Robotic Prostatectomy: a prospective, randomized, interventional comparison - sEAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040819
Enrollment
100
Registered
2026-07-01
Start date
2026-06-24
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

C61

Interventions

Group 1: Intervention Group: Robot-assisted radical prostatectomy with an intraoperative water tightness test (200ml). If the intraoperative test confirms a watertight anastomosis, no postoperative cy

Sponsors

Klinik und Poliklinik für Urologie und Kinderurologie des Universitätsklinikums | Zentrum Operative Medizin (ZOM) | Oberdürrbacher Straße 6 | Haus A2 | 97080 Würzburg
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Indication for a planned robot-assisted radical prostatectomy at the University Hospital Würzburg, and presence of written informed consent after being fully informed about study participation

Exclusion criteria

Exclusion criteria: There are no specific exclusion criteria based on patient characteristics. However, clinical exclusion from randomization into groups A and B occurs if the intraoperative water tightness test of the vesicourethral anastomosis shows a persistent leak

Design outcomes

Primary

MeasureTime frame
Functional outcome (specifically continence and micturition function) assessed via standardized questionnaires (3 months postoperative) Postoperative complication rate measured via the Clavien-Dindo classification system (30d postoperative)

Secondary

MeasureTime frame
Duration of surgery, Re-intervention rate, Duration of hospitalization (routine documentation) Functional outcome after 6 and 12 months

Countries

Germany

Contacts

Public ContactVincent Scheper

Klinik und Poliklinik für Urologie und Kinderurologie des Universitätsklinikums | Zentrum Operative Medizin (ZOM) | Oberdürrbacher Straße 6 | Haus A2 | 97080 Würzburg

scheper_v@ukw.de093120132051

Outcome results

None listed

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