Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126) (DiPRU)

June 18, 2025 updated by: University Hospital, Bordeaux

Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination

The project proposes to evaluate the interest of the UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Kidney cancer represents 2 to 3% of solid cancers in adults. Worldwide, an estimated 431,288 people a year are diagnosed with kidney cancer. Each year, in France, 13,500 patients undergo total or partial nephrectomy. The development of minimally invasive surgical techniques and the structuring of innovative care pathways for the management of renal tumors in Enhanced Rehabilitation After Surgery (RAAC) and even on an outpatient basis have led to a significant reduction in the length of stays. The physiognomy of the course of care for patients operated on for a renal tumor is completely modified and generates for the patient a feeling of deterioration in the quality of care and disruption of medical follow-up.

The objective is to deploy a model for coordinating the perioperative care pathway of patients who have undergone nephrectomy for renal tumor in several French centers in order to assess the impact for patients, caregivers and the health system.

This coordination would lead to the formalization of a nurse coordinator job profile adapted to the specificities of oncological surgery and the tools necessary for its implementation. The UroConnect device has a "patient" interface for presenting self-questionnaires and access to a library of educational content and a "caregiver" interface to rationalize and optimize the nurse's activity of perioperative coordination in his task.

Study Type

Interventional

Enrollment (Estimated)

1307

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Planned surgical management by total or partial nephrectomy for kidney tumor,
  • Affiliation or beneficiary of the French social security
  • Expressed consent for integration of the UroCCR cohort,
  • Expressed consent to participate in the DiPRU study.

Exclusion Criteria:

  • Difficulties understanding and expressing oneself in French
  • Participant under guardianship or curatorship
  • Pregnancy at the time of surgery
  • No internet access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group is based on the pre-existing organization, with no digital patient follow-up tools.
Experimental: Uroconnect Follow Up Group
The UroConnect device has a "patient" interface for presenting self-questionnaires and access to a library of educational content and a "caregiver" interface to rationalize and optimize the nurse's activity of perioperative coordination in his task
Other: Uroconnect Follow Up Group
Inplementation of UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unscheduled and uncoordinated care utilizations
Time Frame: 30 post-operative days
In the 30 post-operative days, number of unscheduled and uncoordinated care utilizations (emergency visits, re-hospitalizations in urology, general medicine or urology consultations) corresponding to the difference between the use of care identified in the National health data system (SNDS) and scheduled and coordinated care, identified in the patient file of the initial hospitalization for scheduled care and by the coordinating nurse for coordinated care.
30 post-operative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient anxiety evaluation
Time Frame: Day-1
Patient anxiety measured by the State-Trait Anxiety Inventory STAI, The STAI questionnaire assesses anxiety as a personality trait and an emotional state and comprised 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Day-1
Hospitalised patient satisfaction and experience evaluation
Time Frame: Day-30 post-op

Patient satisfaction and experience measured by the e-Satis questionnaire .The e-satis questionnaire was created and validated in French by the Haute Autorité de Santé (HAS). It is used as a continuous measure of inpatient satisfaction and experience. It is therefore routinely collected by the HAS.

the e-Satis questionnaires are divided into "dimensions" of the patient pathway (from admission to discharge). Patients respond on a scale ranging from "poor" to "excellent" or from "never" to "always". For each dimension, an overall patient experience and satisfaction score is calculated (A score calculation guide is available on the HAS website).
Day-30 post-op
Nature and reasons for seeking care
Time Frame: Day 30
Nature and reasons for seeking care declared by the patient and confirmed by the doctor who treated him/her
Day 30
Average length of stay
Time Frame: Day 30
Number of re-hospitalizations for complications at D30, use of medical care (medical consultations and hospitalizations) in the 30 days following surgery (SNDS).
Day 30
UroConnect usage
Time Frame: Month 24
Number of alerts generated by UroConnect.
Month 24
Nursing coordination activity linked to UroConnect
Time Frame: Month 24
Evaluation of nurse activity due to patient requests on UroConnect
Month 24
Qualitative analysis of the obstacles and levers to appropriation of UroConnect
Time Frame: Month 24
In each center, professionals and patients will be asked to take part in an individual interviews. This interview will focus on understanding the determining factors in the appropriation of the system and its impact from the point of view of professionals and patients, by identifying 1/ the factors that hinder and encourage appropriation of the system, 2/ the nature of the changes brought about in professional practice and in the patient's care pathway, the patient's feelings in terms of effects on his or her quality of life, disease management and relationship with carers, 3/ the individual, contextual, sociocultural and technical factors in the effectiveness of the intervention.Interview guides will be drawn up in advance, in line with the objectives and hypotheses of the research, and based on the findings of existing literature, such as theoretical models of behavioral and organizational change.
Month 24
Differential real cost for the Hospital
Time Frame: Month 24
Difference in actual costs (€), from the hospital's point of view, between phases with and without the digital tool .
Month 24
Differential cost-consequence ratio
Time Frame: Day 30
Difference in inpatient and outpatient costs (€) between the 2 strategies
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Estimated)

October 23, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2022/77

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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