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

NCT04601129 | Completed

• 2 other identifiers: 2019_212019-A02271-56
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Cell Carcinoma

Keywords

partial nephrectomy; complete nephrectomy; minimally invasive surgery; enhanced recovery after surgery; fast track surgery

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  at 1 month

Secondary Outcomes (5)

• Hospital readmission rate at 1 month post surgery

  at 1 month

• Postoperative antalgic consumption in Enhanced recovery after surgery patients

  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

  Baseline, at 24 hours, at 1 week and at 6 months

• Average Satisfaction of hospital stay and discharge on a satisfaction numerical scale

  at 1 month post surgery

• Neuropathic pain by Douleur Neuropathique 4 (DN4) questionnaire.

  3 and 6 months post surgery

Study Arms (1)

patients

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

Procedure: enhanced recovery after surgery program

Interventions

enhanced recovery after surgery program PROCEDURE

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

patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing minimally invasive surgery partial or total unilateral nephrectomies

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Gilles Lebuffe, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 23, 2020
• Study Start: August 1, 2020
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)