Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery (RREIN)

December 16, 2025 updated by: University Hospital, Lille

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lille, France, 59037
        • Hop Claude Huriez Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing minimally invasive surgery partial or total unilateral nephrectomies

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients
undergoing a minimally invasive nephrectomy, eligible to an Enhanced Recovery After Surgery Program.
Procedure: enhanced recovery after surgery program
practice of an enhanced recovery after surgery program, according to the international reviews of literature and national recommendation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Length of hospital stay
Time Frame: at 1 month
at 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital readmission rate at 1 month post surgery
Time Frame: at 1 month
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
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
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
Satisfaction numerical scale from 0 to 10 : with 0 being the least satisfied possible to 0 being the most satisfied possible
at 1 month post surgery
Neuropathic pain by Douleur Neuropathique 4 (DN4) questionnaire.
Time Frame: 3 and 6 months post surgery
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.
3 and 6 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gilles Lebuffe, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019_21
  • 2019-A02271-56 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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