Ambulatory Surgery After Hepatectomy: Monitoring by Domomedicine Connected Tools and a Dedicated Nurse.

NCT06478810 | Not Yet Recruiting

• 2 other identifiers: APHP1901432018-A03171-54
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Liver Tumor; Hepatectomy

Keywords

Ambulatory surgery; Minor hepatectomy; Domomedicine follow-up

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 30

Secondary Outcomes (7)

• Evaluation of the rate of data collection in patients' homes outside of technical failure.

  Day 30

• Diagnosis of digestive complications

  At Day -3, at Day 0, at Day 1 to Day 7 and at Day 30

• Type of complications

  From Day 0 to Day 30

• Severity of complications (Clavien classification)

  From Day 0 to Day 30

• Mortality rate at Day 30

  Day 30

Study Arms (1)

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

Other: Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy

Interventions

Domomedicine and dedicated nursing care for a close and secure monitoring after an ambulatory hepatectomy OTHER

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.

Ambulatory follow-up (Domomedicine and dedicated nursing care) after a minor Hepatectomy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient unable to be escorted home by a responsible adult upon discharge
• Non-French speaking patient
• Uncompliant patient
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hepato-biliary surgery department

Villejuif, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Nicolas GOLSE

  Hepato-biliary surgery department, Paul Brousse hospital, APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas GOLSE

CONTACT

+ 33 1 45 59 66 25; nicolas.golse@aphp.fr

René ADAM

CONTACT

+ 33 1 45 59 64 09; rene.adam@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: June 27, 2024
• Study Start: September 1, 2024
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

FR (1)