Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery
NCT ID: NCT04601129
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2020-08-01
2023-03-06
Brief Summary
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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
Detailed Description
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The cohort will beneficiate of an extra preoperative information about the enhanced recovery after surgery program, they will benefit from a strategie of low morphine consumption during the per end post operative phase, they should need no bladder or abdominal drainage, they're encourage to eat and drink a few hours after surgery, the intravenous fluid is interrupted as early as possible, and the patients are encourage to sit, stand up and get dressed as soon as they are capable.
A form completed by the patient registers their every day capabilities to eat, drink, move, and their limitations due to pain, dizziness, and nausea. Their bowel and urine transit are also registered. This form is complete until discharge from the hospital.
Their laboratory test is monitored to identify kidney insufficiency or anemia and compared with the preoperative laboratory tests.
The hospital discharge is allowed after medical and surgical criteria are met in both groups.
A surgical evaluation is planned a week, one month, and 6 months after surgery with laboratory exams.
1 month after the discharge, a satisfaction questionnaire is filled up by the patient, answered by telephone.
At the 6 months post operative consultation, a questionnaire about chronic pain is submitted. If the patient is eligible, a chronic pain consultation is further organized.
The result will be compared to those of a retrospective cohort (+/- 60 patients) with no enhanced recovery after surgery program.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients
undergoing a minimally invasive nephrectomy, eligible to an Enhanced Recovery After Surgery Program.
enhanced recovery after surgery program
practice of an enhanced recovery after surgery program, according to the international reviews of literature and national recommendation
Interventions
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enhanced recovery after surgery program
practice of an enhanced recovery after surgery program, according to the international reviews of literature and national recommendation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Gilles Lebuffe, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hop Claude Huriez Chu Lille
Lille, , France
Countries
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Other Identifiers
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2019-A02271-56
Identifier Type: OTHER
Identifier Source: secondary_id
2019_21
Identifier Type: -
Identifier Source: org_study_id