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Shared decision-making in uncomplicated appendicitis: a pragmatic randomized trial comparing patient-driven choice (antibiotics only or appendectomy) with systematic appendectomy (FRENCH 47 — ALACARTE trial)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520783-17-01
Enrollment
560
Registered
2026-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-06

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

Conditions

Adult patients diagnosed with uncomplicated acute appendicitis

Brief summary

The presence of regret about the initial treatment one year after its initiation will be assessed by the answer at the question “You were initially treated for your appendicitis (infection of the appendix) either by surgery with removal of the appendix (appendectomy) or by antibiotic therapy alone without surgery initially. Do you regret the treatment you received? YES - NO."

Detailed description

1/ Patient’s symptom persistence or recurrence at 12 months. Proportion of patients with at least one symptom persistence or recurrence at 12 months., 2/ Patient’s quality of life at 12 months. Quality of life assessed by the EQ-5D-5L questionnaire using the French value set for scoring heath states and fulfilled by the participants (appendix 2)., 3/ The regret at 12 months assessed by the validated decisional regret scale. This standardized scale allows quantifying treatment regret by a score ranging from 0 for no regret to 100 for maximum regret.

Interventions

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The presence of regret about the initial treatment one year after its initiation will be assessed by the answer at the question “You were initially treated for your appendicitis (infection of the appendix) either by surgery with removal of the appendix (appendectomy) or by antibiotic therapy alone without surgery initially. Do you regret the treatment you received? YES - NO."

Secondary

MeasureTime frame
1/ Patient’s symptom persistence or recurrence at 12 months. Proportion of patients with at least one symptom persistence or recurrence at 12 months., 2/ Patient’s quality of life at 12 months. Quality of life assessed by the EQ-5D-5L questionnaire using the French value set for scoring heath states and fulfilled by the participants (appendix 2)., 3/ The regret at 12 months assessed by the validated decisional regret scale. This standardized scale allows quantifying treatment regret by a score ranging from 0 for no regret to 100 for maximum regret.

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 7, 2026