Liver TumorHEPADOMNCT06478810
Ambulatory Surgery After Hepatectomy: Monitoring by Domomedicine Connected Tools and a Dedicated Nurse.
A study testing Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy in people with Liver Tumor and Hepatectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
There are public health expectations for the development of outpatient surgery and increased comfort and quality of care for the patient. In this study, we are interested in evaluating the feasibility of an outpatient hepatectomy with a a close and secure follow-up at home: through a connected platform and a follow-up… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Liver Tumor, Hepatectomy
- What is being tested?
- Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for a minor laparoscopic hepatectomy (benign or malignant liver tumor, requiring resection of 1 or 2 segments maximum)
- Membership in a social security system or beneficiary
- Having given free and informed consent) Exclusion criteria : - Patient living alone and without anyone at home during the first 7 days at home
- Patient unable to be escorted home by a responsible adult upon discharge
- Non-French speaking patient
- Uncompliant patient
Show all 19Show fewer
- Patient not reachable by phone
- Home and convalescence site more than an hour's drive from the Paul Brousse Hospital Hepatobiliary Center
- Women who have started a pregnancy or are breastfeeding
- Previous hepatic surgery or supra-mesocolic surgery (exception: cholecystectomy)
- Previous history of supra-umbilical parietal surgery (hernia/ventricle)
- Contraindication to laparoscopic approach
- ASA score > 2
- Cirrhosis (=F4 fibrosis suspected on Fibroscan or biopsy)
- Coagulation disorder (platelets <100 G/L, INR >1.4), ongoing anticoagulant or antiaggregant treatment that cannot be suspended
- Associated extrahepatic surgery (cholecystectomy allowed) or simultaneous radiofrequency destruction
- Body mass index > 35kg/m2
- Patient under guardianship, curatorship or safeguard of justice
- Patient under AME (state medical aid)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Hepato-biliary surgery department
Villejuif
Nicolas GOLSE, Dr, nicolas.golse@aphp.fr
René ADAM, Pr, rene.adam@aphp.fr
About this study
Official title: Ambulatory Surgery After Hepatectomy: Piloteasibility Study With Securing of the Post-operative Monitoring by Domomedicine Connected Tools and a Dedicated Nurse.
There are public health expectations for the development of outpatient surgery and increased comfort and quality of care for the patient. In this study, we are interested in evaluating the feasibility of an outpatient hepatectomy with a a close and secure follow-up at home: through a connected platform and a follow-up by a nurse. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management). This single-center study will includes prospectively 20 patients requiring liver resection of up to 2 segments. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management).
Read the detailed description
In response to public health expectations for the development of outpatient surgery, ministerial authorities are now encouraging medical facilities to organize their care around this innovative care pathway. Ambulatory surgery is gradually becoming one of the major objectives of any surgical service and many recommendations from the HAS (Haute Autorité de Santé) have recently become available to support and facilitate this transformation. Ambulatory surgery is no longer limited to "simple" surgery but also concerns highly technical surgical procedures with safety conditions identical to those required during conventional hospitalization. Therefore, ambulatory surgery must to limit the risk of postoperative complications but, in case of complications, to do everything possible to manage them quickly and not to make the patient lose chances because of his geographical distance. The main objective of this study is to evaluate the feasibility of a minor hepatectomy under laparoscopy during an ambulatory management. This management will be made possible thanks to the integration of Domomedicine and dedicated nursing care for a close and secure monitoring. The population is 20 major patients with an indication for laparoscopic surgery for peripheral benign or malignant liver tumor requiring liver resection of up to 2 segments. The study lasts a maximum of 15 months (12 months of inclusion, 1 month of patient follow-up and 1 month of prohibition from participating in another interventional study). The study will proceed as described below : • Initial diagnosis of the liver disease : Realization in primary care by a general practitioner (or gastroenterologist or oncologist) and realization of imaging in town
- Confirmation of diagnosis and registration: Surgical consultations and anesthesia consultation at the hospital and registration on the surgical staff list. (Pre-selection visit)
- Pre-operative evaluation (Inclusion visit): Consultation by the surgeon, and dedicated nurse.
- Surgical staff : Collegial evaluation of the surgical file, confirmation of the proposed surgical strategy.
- Preoperative follow-up : Home visit 3 working days before the intervention (Day -3) and telephone call 1 working day before the intervention (Day -1) Dedicated nurse consultation. Delivery of information and materials and information from stakeholders (Family caregivers, city IDE and attending physician)
- Hepatectomy (Day 0) : Outpatient intervention
- Postoperative follow-up =Day 1 to Day 7 + Visit Day 30 Call to Day 1 by the dedicated nurse Follow-up by dedicated nurse of the data transmitted during the 7 days following the hepatectomy coupled with home follow-up by the PRADO nurse, Co-Consultation (dedicated nurse and surgeon) on D7 and D30 (end of follow-up as part of the research).
Return of home medicine devices on Day 7 Report to attending physician.
The expected benefits for the patient are:
- Limitation of infections associated with care (nosocomial)
- Habits, rhythm of life and family and social environment preserved thanks to the return home the same day
- Potentially faster return to work
- Reduction in the cost of hospitalization he expected benefits for the company:
- Optimization of the organization and resources of surgical technical platforms
- Decongestion of hospitalization services
- Sustainability of the health system thanks to shorter stays and therefore less expensive for the Health Insurance
- Implementation of innovative protocols, publications and potential notoriety. The risks of the study are low, the use of the platform will not replace existing uses, but will provide new or additional information whose consistency is verified by the care team. Post-operative follow-up will be equivalent in terms of the frequency of paramedical visits to conventional care (hospitalization > 1 day) and a doctor will be contactable by the dedicated nurse 24 hours a day to organize, if necessary, a transfer to the emergency room or the Hepato-Biliary Center of the Paul Brousse Hospital.
The use of the connected devices does not involve any specific risk because they are non-invasive sensors marketed and marked CE. Regarding the postoperative risk of severe complications (severe bleeding or severe sepsis), this is low, even very low (<0.5%) since we will only include minor hepatectomies. In addition, cirrhotic patients will not be included in this study.
- Conditions
- Liver Tumor, Hepatectomy
- Being tested
- Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy
- Keywords
- Ambulatory surgery, Minor hepatectomy, Domomedicine follow-up
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomyOther
For patient who need a minor hepatectomy under laparoscopy for the standard of care, the follow-up will be an ambulatory follow-up. This ambulatory follow-up will be made possible thanks to the integration of Domomedicine and dedicated nursing care for a close and secure monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory follow-up (Domomedicine and dedicated nursing care) after a minor Hepatectomy | Experimental | Actions added by the research :
* Ambulatory minor Hepatectomy :
* Return home on the day of the operation (no overnight stay in hospital instead of 4-5 nights in standard hospitalization including hospitalization the day before surgery)
* Recording and transmission to the paramedical and medical team of clinical-biological data by connected tools (domomedecine)
* Early care at home via the PRADO health insurance program by a nurse chosen by the patient or one designated by the program.
* Satisfaction Questionnaires and MDASI
* Pain, transit and diet questionnaire
* Paramedical and technological visit on Day -3 Telephone call from the dedicated nurse on Day -1 Telephone interview of the nurse dedicated to Day 1 Receives: Other: Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management).
Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization.
Measured: Day 30
Secondary outcomes (7)
Evaluation of the rate of data collection in patients' homes outside of technical failure.
Evaluation of the rate of data collection in patients' homes outside of technical failure. This will permits to appreciate the adherence to the ambulatory mode of care.
Measured: Day 30
Diagnosis of digestive complications
Digestive complicactions questionnaire, including transit, pain and feeding personnal feeling (internal scale)
Measured: At Day -3, at Day 0, at Day 1 to Day 7 and at Day 30
Type of complications
Type of complications
Measured: From Day 0 to Day 30
Severity of complications (Clavien classification)
Severity of complications following the Clavien classification
Measured: From Day 0 to Day 30
Mortality rate at Day 30
Mortality rate at Day 30
Measured: Day 30
Morbidity rate at Day 30
CCI score (Comprehensive Complication Index) at Day 30
Measured: Day 30
Satisfaction of the ambulatory management.
Score based on three questionnaires completed by the patient : MDASI questionnaire, Quality of life questionnaire (SF36) and Satisfaction of the ambulatory medical support
Measured: MDASI questionnaire : at Day -3, at Day 0 and at Day 1 to Day 7 ; SF 36 questionnaire : Day -3 and at Day 30; Satisfaction of the ambulatory questionnaire at Day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion4 Dec 2025 (estimated)
- Study completion4 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GOLSE, Principal investigator, Hepato-biliary surgery department, Paul Brousse hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478810
- Sponsor's protocol ID
- APHP190143
- Other IDs
- 2018-A03171-54
- Acronym
- HEPADOM
- Status last verified
- Jun 2024
- First submitted
- 31 Oct 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Surgery After Hepatectomy: Piloteasibility Study With Securing of the Post-operative Monitoring by Domomedicine Connected Tools and a Dedicated Nurse.
- ClinicalTrials.gov ID
- NCT06478810
- Acronym / sponsor ID
- HEPADOM / APHP190143
- Conditions
- Liver Tumor, Hepatectomy
- Keywords
- Ambulatory surgery, Minor hepatectomy, Domomedicine follow-up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 4 Dec 2025 (estimated)
- Study completion
- 4 Dec 2025 (estimated)
- First posted
- 27 Jun 2024 (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.
There are public health expectations for the development of outpatient surgery and increased comfort and quality of care for the patient. In this study, we are interested in evaluating the feasibility of an outpatient hepatectomy with a a close and secure follow-up at home: through a connected platform and a follow-up by a nurse. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management). This single-center study will includes prospectively 20 patients requiring liver resection of up to 2 segments. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management).
Detailed description
In response to public health expectations for the development of outpatient surgery, ministerial authorities are now encouraging medical facilities to organize their care around this innovative care pathway. Ambulatory surgery is gradually becoming one of the major objectives of any surgical service and many recommendations from the HAS (Haute Autorité de Santé) have recently become available to support and facilitate this transformation. Ambulatory surgery is no longer limited to "simple" surgery but also concerns highly technical surgical procedures with safety conditions identical to those required during conventional hospitalization. Therefore, ambulatory surgery must to limit the risk of postoperative complications but, in case of complications, to do everything possible to manage them quickly and not to make the patient lose chances because of his geographical distance. The main objective of this study is to evaluate the feasibility of a minor hepatectomy under laparoscopy during an ambulatory management. This management will be made possible thanks to the integration of Domomedicine and dedicated nursing care for a close and secure monitoring. The population is 20 major patients with an indication for laparoscopic surgery for peripheral benign or malignant liver tumor requiring liver resection of up to 2 segments. The study lasts a maximum of 15 months (12 months of inclusion, 1 month of patient follow-up and 1 month of prohibition from participating in another interventional study). The study will proceed as described below : • Initial diagnosis of the liver disease : Realization in primary care by a general practitioner (or gastroenterologist or oncologist) and realization of imaging in town
- Confirmation of diagnosis and registration: Surgical consultations and anesthesia consultation at the hospital and registration on the surgical staff list. (Pre-selection visit)
- Pre-operative evaluation (Inclusion visit): Consultation by the surgeon, and dedicated nurse.
- Surgical staff : Collegial evaluation of the surgical file, confirmation of the proposed surgical strategy.
- Preoperative follow-up : Home visit 3 working days before the intervention (Day -3) and telephone call 1 working day before the intervention (Day -1) Dedicated nurse consultation. Delivery of information and materials and information from stakeholders (Family caregivers, city IDE and attending physician)
- Hepatectomy (Day 0) : Outpatient intervention
- Postoperative follow-up =Day 1 to Day 7 + Visit Day 30 Call to Day 1 by the dedicated nurse Follow-up by dedicated nurse of the data transmitted during the 7 days following the hepatectomy coupled with home follow-up by the PRADO nurse, Co-Consultation (dedicated nurse and surgeon) on D7 and D30 (end of follow-up as part of the research).
Return of home medicine devices on Day 7 Report to attending physician.
The expected benefits for the patient are:
- Limitation of infections associated with care (nosocomial)
- Habits, rhythm of life and family and social environment preserved thanks to the return home the same day
- Potentially faster return to work
- Reduction in the cost of hospitalization he expected benefits for the company:
- Optimization of the organization and resources of surgical technical platforms
- Decongestion of hospitalization services
- Sustainability of the health system thanks to shorter stays and therefore less expensive for the Health Insurance
- Implementation of innovative protocols, publications and potential notoriety. The risks of the study are low, the use of the platform will not replace existing uses, but will provide new or additional information whose consistency is verified by the care team. Post-operative follow-up will be equivalent in terms of the frequency of paramedical visits to conventional care (hospitalization > 1 day) and a doctor will be contactable by the dedicated nurse 24 hours a day to organize, if necessary, a transfer to the emergency room or the Hepato-Biliary Center of the Paul Brousse Hospital.
The use of the connected devices does not involve any specific risk because they are non-invasive sensors marketed and marked CE. Regarding the postoperative risk of severe complications (severe bleeding or severe sepsis), this is low, even very low (<0.5%) since we will only include minor hepatectomies. In addition, cirrhotic patients will not be included in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory follow-up (Domomedicine and dedicated nursing care) after a minor Hepatectomy | Experimental | Other: Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomyActions added by the research : * Ambulatory minor Hepatectomy : * Return home on the day of the operation (no overnight stay in hospital instead of 4-5 nights in standard hospitalization including hospitalization the day before surgery) * Recording and transmission to the paramedical and medical team of clinical-biological data by connected tools (domomedecine) * Early care at home via the PRADO health insurance program by a nurse chosen by the patient or one designated by the program. * Satisfaction Questionnaires and MDASI * Pain, transit and diet questionnaire * Paramedical and technological visit on Day -3 Telephone call from the dedicated nurse on Day -1 Telephone interview of the nurse dedicated to Day 1 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Indication for a minor laparoscopic hepatectomy (benign or malignant liver tumor, requiring resection of 1 or 2 segments maximum)
- Membership in a social security system or beneficiary
- Having given free and informed consent) Exclusion criteria : - Patient living alone and without anyone at home during the first 7 days at home
- Patient unable to be escorted home by a responsible adult upon discharge
- Non-French speaking patient
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomyFor patient who need a minor hepatectomy under laparoscopy for the standard of care, the follow-up will be an ambulatory follow-up. This ambulatory follow-up will be made possible thanks to the integration of Domomedicine and dedicated nursing care for a close and secure monitoring. | Other | Ambulatory follow-up (Domomedicine and dedicated nursing care) after a minor Hepatectomy |
Primary outcome
Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management).
Time frame: Day 30
Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization.
7 secondary outcomes
Evaluation of the rate of data collection in patients' homes outside of technical failure.
Time frame: Day 30
Diagnosis of digestive complications
Time frame: At Day -3, at Day 0, at Day 1 to Day 7 and at Day 30
Type of complications
Time frame: From Day 0 to Day 30
Severity of complications (Clavien classification)
Time frame: From Day 0 to Day 30
Mortality rate at Day 30
Time frame: Day 30
Morbidity rate at Day 30
Time frame: Day 30
Satisfaction of the ambulatory management.
Time frame: MDASI questionnaire : at Day -3, at Day 0 and at Day 1 to Day 7 ; SF 36 questionnaire : Day -3 and at Day 30; Satisfaction of the ambulatory questionnaire at Day 30.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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. This study is not recruiting at the moment.
Nicolas GOLSE principal investigator
Hepato-biliary surgery department, Paul Brousse hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy in people with Liver Tumor and Hepatectomy, run by Assistance Publique - Hôpitaux de Paris 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 19 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GOLSE (+ 33 1 45 59 66 25, nicolas.golse@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management). (time frame: Day 30). 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 27 Jun 2024.