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CompletedNCT04601129RREINUpdated Dec 23, 2025

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

An observational study in Renal Cell Carcinoma, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
01

Study 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
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.

02

Conditions studied

  • Renal Cell Carcinoma

Keywords

  • partial nephrectomy
  • complete nephrectomy
  • minimally invasive surgery
  • enhanced recovery after surgery
  • fast track surgery
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 60 is below the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing minimally invasive surgery partial or total unilateral nephrectomies

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • patients

    undergoing a minimally invasive nephrectomy, eligible to an Enhanced Recovery After Surgery Program.

    Procedure: enhanced recovery after surgery program

Interventions

  • Procedureenhanced recovery after surgery program

    practice of an enhanced recovery after surgery program, according to the international reviews of literature and national recommendation

06

What researchers measure

Primary outcomes

  1. Length of hospital stay

    Time frame: at 1 month

Secondary outcomes

  1. Hospital readmission rate at 1 month post surgery

    Time frame: at 1 month

  2. 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

  3. 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

  4. 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

    Time frame: at 1 month post surgery

  5. 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.

    Time frame: 3 and 6 months post surgery

07

Study locations

1 site
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04601129
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Oct 23, 2020
Start date
Aug 1, 2020
Primary completion
Mar 6, 2023
Completion
Mar 6, 2023
Last update
Dec 23, 2025

Study contacts

Gilles Lebuffe, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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