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NCT Number: NCT06047600

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uroconnect Follow Up Group

Other

Inplementation of UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

  4. 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).

  5. UroConnect usage

    Time frame: Month 24

    Number of alerts generated by UroConnect.

  6. Nursing coordination activity linked to UroConnect

    Time frame: Month 24

    Evaluation of nurse activity due to patient requests on UroConnect

  7. 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.

  8. 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 .

  9. Differential cost-consequence ratio

    Time frame: Day 30

    Difference in inpatient and outpatient costs (€) between the 2 strategies

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Christophe Bernhard, MD, PhD

CONTACT

[email protected]

05.57.82.06.87

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: DiPRU

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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