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Search / Trial NCT06478810

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 24, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Ambulatory Surgery Minor Hepatectomy Domomedicine Follow Up

ClinConnect Summary

This clinical trial is looking at the possibility of performing liver surgery (called hepatectomy) as an outpatient procedure, meaning patients can go home the same day instead of staying in the hospital. The study aims to see if this approach is safe and effective by closely monitoring patients at home using a special connected platform and support from a dedicated nurse. The main goals are to check how many patients need to return to the hospital for complications within 30 days after the surgery and to see if any patients need to be admitted to the hospital due to issues with outpatient care.

To take part in this trial, participants must be between 18 and 69 years old and require a minor laparoscopic liver surgery for a liver tumor that involves removing 1 or 2 segments. However, those living alone without support at home for the first week after surgery, or who can't have someone take them home, won't be eligible. The study will involve 20 patients and will provide an opportunity for them to receive care in a more comfortable setting while ensuring they have the necessary follow-up care.

Gender

ALL

Eligibility criteria

  • Inclusion criteria : - Male or female, 18 to 69 years old
  • 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
  • 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)

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Villejuif, , France

Patients applied

0 patients applied

Trial Officials

Nicolas GOLSE

Principal Investigator

Hepato-biliary surgery department, Paul Brousse hospital, APHP

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported