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Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06808269
Enrollment
210
Registered
2025-02-05
Start date
2025-05-19
Completion date
2026-08-31
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Injury

Keywords

shoulder surgery, pain, comfort

Brief 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.

Interventions

PROCEDUREVivalto 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.

PROCEDURELiberal 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.

Sponsors

Clinique Victor Hugo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity (VAS)3 days, 6 weeks, 3 months and 6 months after surgeryPain will be measured using VAS (visual analog scale), from 0 (no pain) to 10 (maximal pain)

Secondary

MeasureTime frameDescription
Patient comfort (Likert scale)3 days, 6 weeks, 3 months and 6 months after surgeryPatient comfort will be evaluated using a Likert scale for 6 questions. Scale is from 1 (total discomfort) to 5 (total comfort)
Postoperative complications3 days, 6 weeks, 3 months and 6 months after surgery

Countries

France

Contacts

Primary ContactPhilippe Collin, MD
docphcollin@gmail.com+33 6 08 91 47 47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026