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Surgery AmbulatoryORL-CareBOTNCT07917975

Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.

A study testing Post op care evaluation in people with Surgery Ambulatory and ENT Surgery, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Artificial intelligence (AI), and particularly large language models (LLMs), is playing an increasingly important role in medical practice by facilitating documentation, data analysis, and communication with patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Post op care evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteFrance
Study dates
Dec 2026to Apr 2027
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

  • Patient aged 18 years or older
  • Patient undergoing outpatient ENT surgery at the Arthur Vernes Institute
  • Patient covered by a health insurance scheme
  • French-speaking patient
  • Patient who has provided free, informed, and explicit oral consent

Who cannot join

  • Patient already enrolled in a Category 1 interventional research protocol (RIPH 1)
  • Patient without access to equipment enabling use of the chatbot (smartphone or computer)
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under judicial protection (safeguard of justice)
  • Pregnant or breastfeeding patient

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

juliette courtiade mahler, pHD contact

+33144127963

jcourtiade@ghpsj.fr

France1 site
  • Institut Arthur Vernes

    Paris

    Jean-Baptiste Lecanu, MD, +33682137107, jblecanu@institut-vernes.fr

Other trials in France

About this study

Artificial intelligence (AI), and particularly large language models (LLMs), is playing an increasingly important role in medical practice by facilitating documentation, data analysis, and communication with patients. These tools may improve access to medical information and reduce certain repetitive tasks; however, their use remains limited by risks of errors, hallucinations, variability in responses, and the lack of evaluation in real-world healthcare settings.

In the field of patient-provider communication, several studies have shown that AI-generated responses may be perceived as being as relevant as, or even more empathetic and clearer than, those provided by physicians. However, these findings are based predominantly on simulated scenarios and do not allow conclusions regarding the safety of autonomous use in clinical practice.

Read more

Managing patient inquiries outside scheduled consultations represents a substantial workload for healthcare teams. Generative AI could help address this demand, but its implementation requires medical oversight and rigorous safety evaluation.

The postoperative ENT setting provides a relevant area for investigation, as patients frequently experience symptoms that can be difficult to interpret, such as pain, bleeding, or wound-healing complications. A conversational agent could provide consistent responses and continuous accessibility; however, it should never replace on-call medical services. Its primary requirement is the ability to correctly identify situations requiring prompt or urgent medical assessment.

With this objective, a postoperative chatbot was developed using ChatGPT-4 through a secure Retrieval-Augmented Generation (RAG) architecture. Its knowledge base was restricted to recommendations from the French National Authority for Health (HAS), the French Society of Otorhinolaryngology (SFORL), and the PubMed literature in order to improve response reliability. An internal feasibility study yielded encouraging results: 68% of responses were rated as good to excellent by ENT experts, with writing quality and completeness sometimes exceeding those of practicing physicians, although clinicians remained superior in the nuanced assessment of clinical risk.

The objective of the present study is to evaluate the feasibility and acceptability of this ENT postoperative follow-up chatbot among 100 ambulatory surgery patients treated at the Arthur Vernes Institute. The primary aim is to assess the patient experience before evaluating any potential impact on healthcare utilization or medico-economic outcomes.

Being tested
Post op care evaluation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post op care evaluationOther

    Patient will be given access to a post surgery Chat Bot. All the questions asked to the chat bot will be analyzed. At D30 patients will complete a likert scale (0 to 5) and the System usabilty score (0 to 100)

Study groups in NCT07917975
Study groupRoleWhat they receive
Post op CareExperimentalat D30 post surgery, patients will complete 2 scores : Lickert scale and SUS
Receives: Other: Post op care evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the effective use of the chatbot

    Proportion of patients having use the chat bot at least once within the 30Days post surgery

    Measured: up to 30days post surgery

Secondary outcomes (5)
  1. Describe how users can interact with the chatbot.

    number of interaction with the chatbot, topic of the questions

    Measured: up to 30days post surgery

  2. Assess patient acceptance of the chatbot

    System acceptability scale (from 0 to 100)

    Measured: 30days post surgery

  3. Assess patient satisfaction

    likert scale (1 to 5)

    Measured: 30days post surgery

  4. Assess the organizational impact

    number of phone call made during the 30days follow up period after surgery

    Measured: 30days post surgery

  5. Describe clinical events occurring during the follow-up period

    number of out patient visit and hospital stay during the 30days post surgery follow up period

    Measured: 30days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07917975
Sponsor's protocol ID
853_ORL-CareBOT
Acronym
ORL-CareBOT
Status last verified
Nov 2026
First submitted
30 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Post op care evaluation in people with Surgery Ambulatory and ENT Surgery, run by Fondation Hôpital Saint-Joseph at 1 site 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 juliette courtiade mahler, pHD (+33144127963, jcourtiade@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the effective use of the chatbot (time frame: up to 30days post surgery). 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 6 Nov 2026.

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