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NCT07338188: OPTICAIRE

PROMs-guided Perioperative Care in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial

Not yet recruiting NA Last updated 13 January 2026
What this trial tests

NA trial testing Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) in Postoperative Follow-up in 276 participants. Not yet recruiting.

Timeline
31 December 2025
Primary endpoint
3 March 2028
3 April 2028

Quick facts

Lead sponsorUniversity Hospital, Strasbourg, France
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment276
Start date31 December 2025
Primary completion3 March 2028
Estimated completion3 April 2028

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Postoperative Follow-up. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research aims to identify, as early as the preoperative phase, groups of patients likely to experience maximum clinical improvement through structured paramedical follow-up based on PROMs. However, the high heterogeneity of the included patients could have masked more pronounced effects in certain subgroups, particularly those at higher risk. Relying on a multicenter approach and a subgroup analysis, our study hypothesizes that certain patient profiles are more likely to significantly benefit from personalized follow-up based on PROMs. The objective is to validate the hypothesis that support through PROMs for patients in complex situations could allow for a more pronounced clinical effect. This follow-up will enable better targeting of interventions from the preoperative phase, optimize the use of healthcare resources, and improve quality, safety, and efficiency of perioperative pathways.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University Hospital, Strasbourg, France trials

Trials by the same sponsor.

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Data sources for this page

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