Thoracic SurgeryDFPNCT07044440
Digital Follow-up Program After Discharge Home Following Thoracic Surgery
A study testing digital outpatient follow-up and standard follow-up in people with Thoracic Surgery and Mobile Health, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of the study is to evaluate whether a digital follow-up program can improve postoperative pain management and quality of life in patients during the first 28 days after discharge home following thoracic surgery, compared to standard follow-up care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Mobile Health, Post Operative Recovery
- What is being tested?
- digital outpatient follow-up and standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jul 2025to Jun 2026
- 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
- Patients who have signed an informed consent form and underwent a surgery performed at the Thoracic Surgery Department of the University Hospital Basel
- Age ≥ 18 years at the time of informed consent
- First participation in the Study
- Patient operated under general anesthesia
- Patients who are in possession of a smart phone or personal computer and have an e-mail account and are able to answer a digital questionnaire. Or an immediate caretaker in the same household owns a smartphone or personal computer and is familiar with the use
- Patients who understand verbal and written German or French
- Patients discharged at home after surgery
- Hospital stay > 3 nights after surgery
Who cannot join
- Patients under preoperative opioid/cortisone therapy
- Patients who are unable to follow the procedure of the study, e. g. read or understand German or French, psychological disorders, dementia, etc.
- Enrolment of the investigator, his/her family members, employees and other dependent person
- Patients with polytrauma or who underwent mediastinoscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Zeljko Djakovic, MD, +41 61 328 51 96, zeljko.djakovic@usb.ch
Zeljko Djakovic, MD
About this study
Official title: The Development and Evaluation of a Digital Follow-up Program During the Initial Four Weeks After Discharge Home Following Thoracic Surgery. A Confirmatory, Single-center, Prospective, Non-blinded, Randomized, Controlled Study
The aim of the study is to evaluate whether a digital follow-up program can improve postoperative pain management and quality of life in patients during the first 28 days after discharge home following thoracic surgery, compared to standard follow-up care.
Read the detailed description
Thoracic surgery is essential for treating conditions such as thoracic malignancies, trauma, and chronic pulmonary diseases. While often life-saving, recovery after thoracic surgery can be challenging. Enhanced Recovery After Surgery (ERAS) programs have improved outcomes across surgical fields, but their impact on postoperative quality of life (QoL) in thoracic surgery is under-researched.
QoL post-surgery involves factors such as pain, physical and respiratory function, psychological well-being, and return to daily life. Effective communication between patients and their physicians post-discharge is crucial for early detection and management of complications.
Studies in other surgical areas (e.g., colorectal and cardiac surgery) have shown that mobile apps for follow-up can reduce emergency visits, readmissions, and improve patient experience. However, similar evidence is scarce in thoracic surgery. Existing studies suggest electronic patient-reported outcome (ePRO) systems could help monitor symptoms and improve care, but further research is needed.
Despite promising results in other specialties, there is limited evidence on the use of digital tools to monitor and support recovery after thoracic surgery. Given the importance of pain management, QoL, and preventing complications, the researchers aim to explore whether a digital follow-up program could offer measurable benefits for patients recovering at home.
The study aims to develop and evaluate a digital follow-up program for patients in the first 28 days after discharge home from thoracic surgery. The primary objective is to assess whether active, digital patient-physician communication can improve postoperative pain outcomes, compared to standard follow-up care.
- Conditions
- Thoracic Surgery, Mobile Health, Post Operative Recovery, Follow-up
- Being tested
- digital outpatient follow-up, standard follow-up
- Keywords
- Electronic Follow-up, Thoracic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital outpatient follow-upOther
In addition to routine outpatient follow-up visits on day 14 and 28 post-operative, digital follow-up by questionnaire on their health status and general well-being are provided. Possibility to request an interaction with a doctor from our department at any time during the 28 days following discharge
standard follow-upOther
routine outpatient follow-up visits on day 14 and 28 post-operative
| Study group | Role | What they receive |
|---|---|---|
| digital follow-up | Experimental | digital follow-up by questionnaire in addition to routine follow-up Receives: Other: digital outpatient follow-up |
| standard follow-up | Active comparator | routine follow-up Receives: Other: standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain perception
Impact on the subjective pain perception is assessed by the numeric rating scale (NRS). Scale ranges from 0-10 while 10 indicates more pain
Measured: 4 weeks after discharge home
Secondary outcomes (5)
General well-being
General well-being is assessed by the numeric rating scale (NRS). Scale ranges from 0-10 while 10 indicates better outcome
Measured: 4 weeks after discharge home
Post-Discharge documentation of analgesic use
Assessment of any analgesics admitted after discharge home
Measured: During the 4 weeks after discharge home
Emergency consultations
Number of emergency consultations within 4 weeks after discharge home
Measured: During the 4 weeks after discharge home
Readmissions
Measured: During the 4 weeks after discharge home
postoperative complications
postoperative complications after hospital discharge home according to the Clavien-Dindo Classification of surgical complications
Measured: During the 4 weeks after discharge home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start30 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Lardinois, Prof. MD, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044440
- Sponsor's protocol ID
- 2025-00796;kt25Lardinois3
- Other IDs
- 2025
- Acronym
- DFP
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of a Digital Follow-up Program During the Initial Four Weeks After Discharge Home Following Thoracic Surgery. A Confirmatory, Single-center, Prospective, Non-blinded, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07044440
- Acronym / sponsor ID
- DFP / 2025-00796;kt25Lardinois3
- Conditions
- Thoracic Surgery, Mobile Health, Post Operative Recovery, Follow-up
- Keywords
- Electronic Follow-up, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
The aim of the study is to evaluate whether a digital follow-up program can improve postoperative pain management and quality of life in patients during the first 28 days after discharge home following thoracic surgery, compared to standard follow-up care.
Detailed description
Thoracic surgery is essential for treating conditions such as thoracic malignancies, trauma, and chronic pulmonary diseases. While often life-saving, recovery after thoracic surgery can be challenging. Enhanced Recovery After Surgery (ERAS) programs have improved outcomes across surgical fields, but their impact on postoperative quality of life (QoL) in thoracic surgery is under-researched.
QoL post-surgery involves factors such as pain, physical and respiratory function, psychological well-being, and return to daily life. Effective communication between patients and their physicians post-discharge is crucial for early detection and management of complications.
Studies in other surgical areas (e.g., colorectal and cardiac surgery) have shown that mobile apps for follow-up can reduce emergency visits, readmissions, and improve patient experience. However, similar evidence is scarce in thoracic surgery. Existing studies suggest electronic patient-reported outcome (ePRO) systems could help monitor symptoms and improve care, but further research is needed.
Despite promising results in other specialties, there is limited evidence on the use of digital tools to monitor and support recovery after thoracic surgery. Given the importance of pain management, QoL, and preventing complications, the researchers aim to explore whether a digital follow-up program could offer measurable benefits for patients recovering at home.
The study aims to develop and evaluate a digital follow-up program for patients in the first 28 days after discharge home from thoracic surgery. The primary objective is to assess whether active, digital patient-physician communication can improve postoperative pain outcomes, compared to standard follow-up care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital follow-up | Experimental | Other: digital outpatient follow-updigital follow-up by questionnaire in addition to routine follow-up |
| standard follow-up | Active comparator | Other: standard follow-uproutine follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who have signed an informed consent form and underwent a surgery performed at the Thoracic Surgery Department of the University Hospital Basel
- Age ≥ 18 years at the time of informed consent
- First participation in the Study
- Patient operated under general anesthesia
- Patients who are in possession of a smart phone or personal computer and have an e-mail account and are able to answer a digital questionnaire. Or an immediate caretaker in the same household owns a smartphone or personal computer and is familiar with the use
Key exclusion criteria (4 listed)
- Patients under preoperative opioid/cortisone therapy
- Patients who are unable to follow the procedure of the study, e. g. read or understand German or French, psychological disorders, dementia, etc.
- Enrolment of the investigator, his/her family members, employees and other dependent person
- Patients with polytrauma or who underwent mediastinoscopy
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 |
|---|---|---|
| digital outpatient follow-upIn addition to routine outpatient follow-up visits on day 14 and 28 post-operative, digital follow-up by questionnaire on their health status and general well-being are provided. Possibility to request an interaction with a doctor from our department at any time during the 28 days following discharge | Other | digital follow-up |
| standard follow-uproutine outpatient follow-up visits on day 14 and 28 post-operative | Other | standard follow-up |
Primary outcome
Subjective pain perception
Time frame: 4 weeks after discharge home
Impact on the subjective pain perception is assessed by the numeric rating scale (NRS). Scale ranges from 0-10 while 10 indicates more pain
5 secondary outcomes
General well-being
Time frame: 4 weeks after discharge home
Post-Discharge documentation of analgesic use
Time frame: During the 4 weeks after discharge home
Emergency consultations
Time frame: During the 4 weeks after discharge home
Readmissions
Time frame: During the 4 weeks after discharge home
postoperative complications
Time frame: During the 4 weeks after discharge home
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 5 Aug 2025.
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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.
Didier Lardinois, Prof. MD study chair
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital outpatient follow-up and standard follow-up in people with Thoracic Surgery and Mobile Health, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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 Switzerland. 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 Zeljko Djakovic, MD (+41 61 328 51 96, zeljko.djakovic@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective pain perception (time frame: 4 weeks after discharge home). 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 5 Aug 2025.