Partial Nephrectomy in Low Pressure
NCT05404685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2025-06-13
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 after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.
Conditions
- Kidney Tumors Treated With Minimally Invasive Surgery
Interventions
- DEVICE
-
Low insufflation pressure (7mm Hg) for Robotic Assisted Partial Nephrectomy
Use of insufflation pressure at 7 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system. The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization.
- DEVICE
-
Standard insufflation pressure (12mm Hg) for Robotic Assisted Partial Nephrectomy
Use of insufflation pressure at 12 mm Hg. The groups will differ only with respect to the insufflation pressure level set on the AirSeal® system. The level of pressure will be adjusted at the beginning of the surgery, after placement of the trocars, in accordance with the result of the randomization.
Sponsors & Collaborators
-
University Hospital, Bordeaux
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-04
- Primary Completion
- 2024-04-29
- Completion
- 2024-04-29
Countries
- France
Study Locations
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