Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery (NCT04601129) | Clinical Trial Compass
CompletedNot Applicable
Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery
France60 participantsStarted 2020-08-01
Plain-language summary
Shorten the time spent in the hospital (hospitalization duration) by optimizing the pre, per and postoperative care is of major medical and economic importance.
Minimally invasive surgery allows a faster recovery than open surgery. However, we need to ensure an early and secure return to normality in order to discharge patients safely from the hospital.
Clinical and biological parameters need to be controlled post-surgery.
This work is going to evaluate the efficacity of a fast - recovery program with incoming patients receiving minimally invasive surgery (laparoscopic or robotic) of partial and total nephrectomy.
The implementation of a medical and surgical fast-recovery program could
* Lower the average duration of stay in hospital (at least by 1 day) with no increase of morbidity
* Insure the absence of complications after 6 months home
Who can participate
Age range
18 Years – 75 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:
* Patient score from the American Society of Anesthesiologist (ASA) I, II or III stable
* Patients undergoing minimally invasive surgery (laparoscopic or robotic) partial or total unilateral nephrectomies for tumoral \< pT2 stage (7 cm) with no tumor spread of the retro-peritoneal tissue, vascular or urinary tract.
* Surgery must be performed by a laparoscopic and robotic-assisted surgeon, operator must be trained using these techniques
Exclusion Criteria:
* Patient score from the American Society of Anesthesiologist (ASA) III unstable, IV and V
* Patients with renal insufficiency defined by clearance \< 60 ml/min/1,73m2 (CKD-EPI)
* Patients with high embolic risk under long-term anti-coagulation medication
* Patients with congenital hemostatic deficit or antiplatelet treatment
* Patients with long term corticosteroids treatments
* History of kidney surgery or congenital unique kidney
* History of multiple abdominal surgery creating a hostile surgical environment
* intestinal chronic disease or chronic pain syndrome
* Psychiatric disorder, cognitive impairment reducing the ability to understand the discharge instructions
* Pregnant or breast-feeding women
* Patients with no social security covers
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.