Digitizing Perioperative Nursing CoordinationDiPRUNCT06047600
Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126)
A study testing Uroconnect Follow Up Group in people with Digitizing Perioperative Nursing Coordination, run by University Hospital, Bordeaux at 11 sites in France.
Trial summary
The project proposes to evaluate the interest of the UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digitizing Perioperative Nursing Coordination
- What is being tested?
- Uroconnect Follow Up Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,307 participants
- Where
- 11 sitesFrance
- Study dates
- 23 Oct 2023to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Difficulties understanding and expressing oneself in French
- Participant under guardianship or curatorship
- Pregnancy at the time of surgery
- No internet access
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CHU d'Angers
Angers
Pierre Bigot, Pr, PiBigot@chu-angers.fr
- Recruiting
CHU de Bordeaux
Bordeaux
Jean-Christophe Bernhard, MD,PhD, Jean-christophe.bernhard@chu-bordeaux.fr
- Recruiting
Centre Catalan d'Urologie
Cabestany
Pierre Gimel, Dr, gimel@urologie66.fr
- Recruiting
CHU de Caen
Caen
Thibaut Waeckel, Dr, 02.31.06.49.47
- Recruiting
Hôpital Henri Mondor
Créteil
Alexandre Ingels, Dr, alexandre.ingels@aphp.fr
- Recruiting
APHM
Marseille
Romain Boissier, Pr, romain.boissier@ap-hm.fr
- Recruiting
CH de Mont de Marsan
Mont-de-Marsan
Jean-Jacques Patard, Pr, jean-jacques.patard@ch-mdm.fr
- Recruiting
CHU de Nantes
Nantes
De VERGIE Stéphane, Dr
- Recruiting
CHU de Nîmes
Nîmes
Alexis Fontenil, Dr, alexis.fontenil@chu-nimes.fr
- Recruiting
CHU de Strasbourg
Strasbourg
Hervé LANG, Pr., herve.lang@chru-strasbourg.fr
- Recruiting
CHu de Toulouse
Toulouse
Nicolas Doumerc, Dr, doumerc.n@chu-toulouse.fr
About this study
Official title: 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
Read the 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.
- Being tested
- Uroconnect Follow Up Group
- Keywords
- Kidney tumor, Digital tool, Care pathways, Cost analysis, Health economic evaluation
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uroconnect Follow Up GroupOther
Inplementation of UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group is based on the pre-existing organization, with no digital patient follow-up tools. |
| Uroconnect Follow Up Group | Experimental | 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 Receives: Other: Uroconnect Follow Up Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unscheduled and uncoordinated care utilizations
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.
Measured: 30 post-operative days
Secondary outcomes (9)
Patient anxiety evaluation
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.
Measured: Day-1
Hospitalised patient satisfaction and experience evaluation
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).
Measured: Day-30 post-op
Nature and reasons for seeking care
Nature and reasons for seeking care declared by the patient and confirmed by the doctor who treated him/her
Measured: Day 30
Average length of stay
Number of re-hospitalizations for complications at D30, use of medical care (medical consultations and hospitalizations) in the 30 days following surgery (SNDS).
Measured: Day 30
UroConnect usage
Number of alerts generated by UroConnect.
Measured: Month 24
Nursing coordination activity linked to UroConnect
Evaluation of nurse activity due to patient requests on UroConnect
Measured: Month 24
Qualitative analysis of the obstacles and levers to appropriation of UroConnect
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.
Measured: Month 24
Differential real cost for the Hospital
Difference in actual costs (€), from the hospital's point of view, between phases with and without the digital tool .
Measured: Month 24
Differential cost-consequence ratio
Difference in inpatient and outpatient costs (€) between the 2 strategies
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 Oct 2023
- Primary completion23 Oct 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digitizing Perioperative Nursing CoordinationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- cross-sectional stepped wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047600
- Sponsor's protocol ID
- CHUBX2022/77
- Acronym
- DiPRU
- Status last verified
- Jun 2025
- First submitted
- 6 Sep 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination
- ClinicalTrials.gov ID
- NCT06047600
- Acronym / sponsor ID
- DiPRU / CHUBX2022/77
- Keywords
- Kidney tumor, Digital tool, Care pathways, Cost analysis, Health economic evaluation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,307 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project proposes to evaluate the interest of the UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cross-sectional stepped wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group is based on the pre-existing organization, with no digital patient follow-up tools. |
| Uroconnect Follow Up Group | Experimental | Other: Uroconnect Follow Up GroupThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Difficulties understanding and expressing oneself in French
- Participant under guardianship or curatorship
- Pregnancy at the time of surgery
- No internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uroconnect Follow Up GroupInplementation of UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination. | Other | Uroconnect Follow Up Group |
Primary outcome
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.
9 secondary outcomes
Patient anxiety evaluation
Time frame: Day-1
Hospitalised patient satisfaction and experience evaluation
Time frame: Day-30 post-op
Nature and reasons for seeking care
Time frame: Day 30
Average length of stay
Time frame: Day 30
UroConnect usage
Time frame: Month 24
Nursing coordination activity linked to UroConnect
Time frame: Month 24
Qualitative analysis of the obstacles and levers to appropriation of UroConnect
Time frame: Month 24
Differential real cost for the Hospital
Time frame: Month 24
Differential cost-consequence ratio
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uroconnect Follow Up Group in people with Digitizing Perioperative Nursing Coordination, run by University Hospital, Bordeaux at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe Bernhard, MD, PhD (05.57.82.06.87, Jean-christophe.bernhard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of unscheduled and uncoordinated care utilizations (time frame: 30 post-operative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.