Clinical trial · Interventional
Partial Nephrectomy in Low Pressure
Randomised Study to Assess the Feasibility and Outcomes of Robotic Assisted Partial Nephrectomy in Low Pressure With AirSeal
NCT05404685CI-TRIAL-00090992P-NeLoPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Tumors Treated With Minimally Invasive Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy | Device | — | UNRESOLVED |
| Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transperitoneal RAPN with AirSeal system set to 7mmH.
- description
- Patient with Low Pressure Robotic Assisted Partial Nephrectomy at 7mm Hg
- interventionNames
- Device: Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy
- type
- ACTIVE_COMPARATOR
- label
- transperitoneal RAPN with AirSeal system set to standard insufflation pressure (12mmHg)
- description
- Control arm : Patient with standard insufflation pressure of 12 mm Hg
- interventionNames
- Device: Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy
Primary outcomes (1)
- measure
- Intensity of post-operative pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female aged of 18 and over * Planned transperitoneal RAPN for tumor with AirSeal system. * Affiliation to or beneficiary of the French social security * Patient in capacity and willing to accurately report pain-killer intakes in the first postoperative 7 days. * Free, informed and written consent signed by the patient and the investigating physician (at the latest on the day of inclusion and before any examination required by the research). Exclusion criteria: * Daily chronic pain-killers intake for another indication than the kidney tumor and intended to be maintained at the time of surgery * Person deprived of liberty * Person under trusteeship, curatorship or legal guardianship * Refusal of consent or participation in the UroCCR project and the P-NeLoP ancillary trial Exclusion Criteria: \-
References
Publications (1)
- DERIVEDMargue G, Bigot P, Ingels A, Roupret M, Waeckel T, Long JA, Pignot G, Bensalah K, Lang H, Olivier J, Bruyere F, Durand M, Beauval JB, Mallet R, Parier B, De La Taille A, Bernhard JC. Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study). Trials. 2023 Aug 19;24(1):545. doi: 10.1186/s13063-023-07533-4. PMID 37596613