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

University Hospital, Lille

Status

Completed

Conditions

Renal Cell Carcinoma

Treatments

Procedure: enhanced recovery after surgery program

Study type

Observational

Funder types

Other

Identifiers

NCT04601129

2019_21

2019-A02271-56 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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