Clinical trial NCT04601129: Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery
Official title: Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Cell Carcinoma
Keywords: partial nephrectomy
complete nephrectomy
minimally invasive surgery
enhanced recovery after surgery
fast track surgery
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing minimally invasive surgery partial or total unilateral nephrectomies

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: at 1 month
Secondary outcomes:
measure: Hospital readmission rate at 1 month post surgery
timeFrame: at 1 month
measure: Postoperative antalgic consumption in Enhanced recovery after surgery patients
timeFrame: through the hospitalization, up to 5 days post surgery and long term, average of 6 months post surgery
measure: Preoperative and postoperative Creatinine and Clearance of creatinine Delta by the CKD-EPI formula
timeFrame: Baseline, at 24 hours, at 1 week and at 6 months
measure: Average Satisfaction of hospital stay and discharge on a satisfaction numerical scale
timeFrame: at 1 month post surgery
measure: Neuropathic pain by Douleur Neuropathique 4 (DN4) questionnaire.
timeFrame: 3 and 6 months post surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: