Clinical trial · Interventional
Effect of Peritoneal Fixation on Lymphocele Formation
Prospective Randomized Trial Evaluating the Effect of Peritoneal Flap Fixation on Symptomatic and Radiologic Lymphocele Formation Following Robot Assisted Radical Prostatectomy With Extended Pelvic Lymph Node Dissection (PerFix)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The PerFix Trial aims to compare the use of peritoneal fixation technique to standard of care (no fixation) during robot-assisted radical prostatectomy with extended pelvic lymph node dissection (RARP + eLND) for the prevention of symptomatic and radiologic lymphocele formation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocele After Surgical Procedure | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peritoneal fixation (PerFix) | Procedure | — | UNRESOLVED |
| Standard of care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group (PerFix)
- description
- Peritoneal fixation technique
- interventionNames
- Procedure: Peritoneal fixation (PerFix)
- type
- ACTIVE_COMPARATOR
- label
- Control group (no PerFix)
- description
- Standard of care (i.e. no fixation)
- interventionNames
- Procedure: Standard of care
Primary outcomes (1)
- measure
- Number of participants with Symptomatic lymphocele
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Able to give informed consent * Histologically proven high risk prostate cancer or intermediate risk cancer (≥5% risk of nodal involvement on Briganti 2012 nomogram) according to European Association od Urology (EAU) risk groups * Suitable for minimally-invasive surgery Exclusion Criteria: * Previous pelvic surgery or irradiation. * Any type of clotting disorder. * Patients unwilling to undergo CT scan * Kidney failure, Hemodialysis * American Society of Anesthesiology Classification\> 3 * Existing contraindications for performing a lymph node dissection
References
Publications (0)
Data not yet available