Cost-effectivness of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in Context of Renal Tumor

NCT05089006 | Completed

• 1 other identifier: écoREIN
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aim to analyze cost-effectiveness of robot-assisted surgery compared to open surgery for partial nephrectomy in the context of renal tumor. A total of 400 patients were recruited in two centers in France corresponding to Reims(n=200) and Nancy hospital center (n=200). Patients recruited in Reims are corresponding to open surgery strategy, while patients of Nancy center are corresponding to robot-assisted surgery. Costs analyzed included cost of intervention, hospital stay and complications. Effectiveness measure is corresponding to the rate of patients without acute complication at one year.

Conditions

Renal Tumor

Keywords

kidney cancer; robot-assisted surgery; cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Incremental cost-effectiveness ratio estimating cost per one acute post-operative complication averted

  post-operative complication represents a relevant indicator in the context of renal nephrectomy. We aim to estimate the cost associated with one complication averted

  one year

Secondary Outcomes (1)

• Difference in hospital stay duration between robot-assisted and open surgery

  one year

Study Arms (2)

robot-assisted surgery group

Patients undergoing robot-assisted surgery for small renal tumor

Procedure: Partial nephrectomy with robot-assisted and open surgery

open surgery group

Patients undergoing open surgery for small renal tumor

Procedure: Partial nephrectomy with robot-assisted and open surgery

Interventions

Partial nephrectomy with robot-assisted and open surgery PROCEDURE

Robot-assisted partial nephrectomy (RAPN) is considered as a feasible minimally invasive alternative to open partial nephrectomy (OPN) for the surgical treatment of renal tumors. The main advantages of this technique include a three-dimensional magnified view of the surgical field, enhanced dexterity, and greater precision in both dissection and reconstruction.

open surgery group; robot-assisted surgery group

Eligibility Criteria

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

Study Population

Patients over 18 years old that undergone partial nephrectomy in Nancy and Reims center for small renal tumor.

You may qualify if:

• Patients undergoing partial nephrectomy surgery for renal tumor
• Patients that gave informed consent for participating to the study

You may not qualify if:

• Patients undergoing partial nephrectomy surgery for other indication
• Patients that refused participation to the study
• Patients with horseshoe kidney
• Patients undergoing total nephrectomy for renal tumor

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (1)

• Baghli A, Achit H, Audige V, Larre S, Branchu B, Balkau B, Eschwege P, Hubert J, Mazeaud C. Cost-effectiveness of robotic-assisted surgery vs open surgery in the context of partial nephrectomy for small kidney tumors. J Robot Surg. 2023 Aug;17(4):1571-1578. doi: 10.1007/s11701-023-01552-8. Epub 2023 Mar 15.

  PMID: 36918464 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; 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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 22, 2021
• Study Start: January 1, 2008
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share