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.
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
- Conditions the study is for
- Surgery Ambulatory, ENT Surgery, Post Surgical Management
- 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.
France1 site
Institut Arthur Vernes
Paris
Jean-Baptiste Lecanu, MD, +33682137107, jblecanu@institut-vernes.fr
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.
- Conditions
- Surgery Ambulatory, ENT Surgery, Post Surgical Management
- 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 group | Role | What they receive |
|---|---|---|
| Post op Care | Experimental | at 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.
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)
Describe how users can interact with the chatbot.
number of interaction with the chatbot, topic of the questions
Measured: up to 30days post surgery
Assess patient acceptance of the chatbot
System acceptability scale (from 0 to 100)
Measured: 30days post surgery
Assess patient satisfaction
likert scale (1 to 5)
Measured: 30days post surgery
Assess the organizational impact
number of phone call made during the 30days follow up period after surgery
Measured: 30days post surgery
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.
- First posted5 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery AmbulatoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.
- ClinicalTrials.gov ID
- NCT07917975
- Acronym / sponsor ID
- ORL-CareBOT / 853_ORL-CareBOT
- Conditions
- Surgery Ambulatory, ENT Surgery, Post Surgical Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post op Care | Experimental | Other: Post op care evaluationat D30 post surgery, patients will complete 2 scores : Lickert scale and SUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post op care evaluationPatient 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) | Other | Post op Care |
Primary outcome
Determine the effective use of the chatbot
Time frame: up to 30days post surgery
Proportion of patients having use the chat bot at least once within the 30Days post surgery
5 secondary outcomes
Describe how users can interact with the chatbot.
Time frame: up to 30days post surgery
Assess patient acceptance of the chatbot
Time frame: 30days post surgery
Assess patient satisfaction
Time frame: 30days post surgery
Assess the organizational impact
Time frame: 30days post surgery
Describe clinical events occurring during the follow-up period
Time frame: 30days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.