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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Ambulatory follow-up (Domomedicine and dedicated nursing care) after a minor HepatectomyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Day 30

Secondary outcomes

1

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.

Time frame
Day 30
2

Diagnosis of digestive complications

Digestive complicactions questionnaire, including transit, pain and feeding personnal feeling (internal scale)

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

Type of complications

Type of complications

Time frame
From Day 0 to Day 30
4

Severity of complications (Clavien classification)

Severity of complications following the Clavien classification

Time frame
From Day 0 to Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: