Status:
COMPLETED
Partial Nephrectomy in Low Pressure
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Kidney Tumors Treated With Minimally Invasive Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 a...
Detailed Description
Minimally invasive route for PN is recommended to offer patients ERAS and day-case pathways leading to the best possible recovery. In this setting, pain management is crucial and every innovation supp...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
October 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05404685
Start Date
October 4 2022
End Date
April 29 2024
Last Update
June 13 2025
Active Locations (15)
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1
CHU d'Angers
Angers, France, 49933
2
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
3
CHU de Caen
Caen, France, 14033
4
Hopital Henri-Mondor
Créteil, France, 94010