Ireland
--:--IST
Recruiting Not applicable

Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

NCT06808269 · tracked via the Priya Life Science France tracker
Sponsor
Clinique Victor Hugo
Phase
Not applicable
Started
2025-05-19
Last updated
2026-10-05

Condition(s) studied

Shoulder Injury

Investigational drug(s) / intervention(s)

Vivalto Dom follow-upLiberal follow-up

Vivalto Dom follow-up: During the pre-operative consultation, the patient receives a prescription for medication (analgesics and anti-inflammatories) for immediate post-operative pain relief. They also receive a "patient information booklet" (see appendix 6). On discharge from surgery, the patient returns home with Vivalto Dom in charge of nursing care and follow-up medication. Vivalto Dom is a homecare structure whose mission is to coordinate the discharge of patients back home, and to ensure continuity of overall care (care and social aspects) between the hospital and the city.

Liberal follow-up: The pre-operative and operative course (fasting rules, skin preparation, hospitalization, surgery) is the same as for all routine care patients. The patient is informed before surgery that he or she must make an appointment with a nurse for post-operative care at home; a prescription for medication (analgesics and anti-inflammatories) has been given by the anaesthetist for immediate analgesic treatment, and on discharge from hospital he or she receives another prescription from the surgeon for oral relay treatment. Follow-up at home takes place over 3 days, with a private nurse visiting the patient's home every day. During the follow-up, the nurse performs clinical monitoring of the following items: pulse, blood pressure, temperature, pain, bleeding, monitoring of the surgical wound, transit, nausea and vomiting. The patient is also guided through the medication protocol.

Study summary

Post-operative management of shoulder surgery patients, particularly in terms of pain management and follow-up, can vary from one center to another, influencing clinical outcomes and patient satisfaction. The aim of this study is to compare two approaches to post-operative follow-up in two distinct centers: structured follow-up using the Vivalto-Dom protocol in Paris, and autonomous follow-up through contact with a nurse in Saint-Grégoire. The hypothesis is that these differences in the care pathway will affect pain management, comfort and patient satisfaction. By controlling for operative variability (a single surgeon operating in both centers), the study will identify the most effective follow-up practices for improving post-operative management, with the ultimate aim of optimizing quality of care and reducing post-operative complications.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient eligible for one of the following 4 types of surgery: Simple non-repair arthroscopic surgery (acromion, calcification), arthroscopic repair surgery (cuff, DAS, bankart), open surgery without prosthesis (ligamentoplasty, bone block), open surgery with prosthesis (inverted prosthesis, anatomic prosthesis, etc.). Exclusion Criteria: * Patients with one or more communication disorders. * Pregnant or breast-feeding patients * Patients not covered by a social security scheme * Refusal to participate in research * Patients unable to understand or give informed consent * Patients under guardianship, deprived of liberty or under court protection * Patients with past or present drug addiction * Patients with neuropathy * Patients with cognitive disorders * Patients with chronic illnesses or inflammatory pathologies leading to chronic pain.

Primary outcome measure(s)

  • Pain intensity (VAS) — 3 days, 6 weeks, 3 months and 6 months after surgery
    Pain will be measured using VAS (visual analog scale), from 0 ("no pain") to 10 (maximal pain)

Trial sites (2)

FacilityCityRegionStatus
Clinique Victor Hugo Paris France Recruiting
Centre hospitalier privé Saint-Grégoire Saint-Grégoire France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06808269 on ClinicalTrials.gov ↗ ← All trials in France