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Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.

NCT03943771 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-01-27

No results posted yet for this study

Summary

Investigators aimed to estimate the effect of showing and handling a three-dimensional modelization of a patient's kidney presenting with tumor the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI score. 2 types kidney models (virtual and printed) will be evaluated as compared to usual information, using a randomization.

Conditions

  • Kidney Neoplasms
  • Carcinoma, Renal Cell

Interventions

OTHER

Anxiety, renal anatomy and surgery questionnaires

The day before surgery, all the patients will be visited by a member of the investigator team for preoperative consultation and will be given a questionnaire evaluating their anxiety based on STAI and VAS scores. The two experimental groups will be offered their renal modelization to be manipulated (virtually or physically) before the questionnaire. A second survey assessing basic renal anatomy and surgery understanding will also be completed by the patients. Anxiolytics prescription prior to surgery will be collected inside the medical file.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943771 on ClinicalTrials.gov