Renal Cell CarcinomaRREINNCT04601129
Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery
An observational study of Renal Cell Carcinoma, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- enhanced recovery after surgery program
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 6 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing minimally invasive surgery partial or total unilateral nephrectomies
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the detailed description
Prospective study of a fast recovery program evaluating the impact on the hospitalization length and the incidence of re-hospitalization for complications for 60 patients undergoing a minimally invasive nephrectomy.
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
- Renal Cell Carcinoma
- Being tested
- enhanced recovery after surgery program
- Keywords
- partial nephrectomy, complete nephrectomy, minimally invasive surgery, enhanced recovery after surgery, fast track surgery
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced recovery after surgery programProcedure or surgery
practice of an enhanced recovery after surgery program, according to the international reviews of literature and national recommendation
| Study group | Role | What they receive |
|---|---|---|
| patients | undergoing a minimally invasive nephrectomy, eligible to an Enhanced Recovery After Surgery Program. Receives: Procedure: enhanced recovery after surgery program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: at 1 month
Secondary outcomes (5)
Hospital readmission rate at 1 month post surgery
Measured: at 1 month
Postoperative antalgic consumption in Enhanced recovery after surgery patients
Measured: through the hospitalization, up to 5 days post surgery and long term, average of 6 months post surgery
Preoperative and postoperative Creatinine and Clearance of creatinine Delta by the CKD-EPI formula
Measured: Baseline, at 24 hours, at 1 week and at 6 months
Average Satisfaction of hospital stay and discharge on a satisfaction numerical scale
Satisfaction numerical scale from 0 to 10 : with 0 being the least satisfied possible to 0 being the most satisfied possible
Measured: at 1 month post surgery
Neuropathic pain by Douleur Neuropathique 4 (DN4) questionnaire.
The questionnaire is made of 10 binnaire questions with "yes" or "no" answers, yes standing for 1 point, no standing for 0 point. The minimum score is 0 reflecting the absence of neuropathic pain, the maximum score is 10 reflecting the most intense neuropathic pain possible. The test is positive for the diagnosis of post surgical neuropathic pain at a score of 4 and above.
Measured: 3 and 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Aug 2020
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601129
- Sponsor's protocol ID
- 2019_21
- Other IDs
- 2019-A02271-56
- Acronym
- RREIN
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery
- ClinicalTrials.gov ID
- NCT04601129
- Acronym / sponsor ID
- RREIN / 2019_21
- Conditions
- Renal Cell Carcinoma
- Keywords
- partial nephrectomy, complete nephrectomy, minimally invasive surgery, enhanced recovery after surgery, fast track surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Prospective study of a fast recovery program evaluating the impact on the hospitalization length and the incidence of re-hospitalization for complications for 60 patients undergoing a minimally invasive nephrectomy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: enhanced recovery after surgery programundergoing a minimally invasive nephrectomy, eligible to an Enhanced Recovery After Surgery Program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing minimally invasive surgery partial or total unilateral nephrectomies
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced recovery after surgery programpractice of an enhanced recovery after surgery program, according to the international reviews of literature and national recommendation | Procedure or surgery | patients |
Primary outcome
Length of hospital stay
Time frame: at 1 month
5 secondary outcomes
Hospital readmission rate at 1 month post surgery
Time frame: at 1 month
Postoperative antalgic consumption in Enhanced recovery after surgery patients
Time frame: through the hospitalization, up to 5 days post surgery and long term, average of 6 months post surgery
Preoperative and postoperative Creatinine and Clearance of creatinine Delta by the CKD-EPI formula
Time frame: Baseline, at 24 hours, at 1 week and at 6 months
Average Satisfaction of hospital stay and discharge on a satisfaction numerical scale
Time frame: at 1 month post surgery
Neuropathic pain by Douleur Neuropathique 4 (DN4) questionnaire.
Time frame: 3 and 6 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Lebuffe, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.