CompletedNot Applicable

Partial Nephrectomy in Low Pressure

France280 participantsStarted 2022-10-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intensity of post-operative pain

Timeframe: 24 hours after surgery

Trial details

NCT IDNCT05404685

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-29

View on ClinicalTrials.gov More Kidney Tumors Treated With Minimally Invasive Surgery trials