Enhanced Recovery After Hepatic Surgery (MultiPAS).

Liver Surgery Clinical Trial

— MultiPAS  

Official title:

Enhanced Recovery After Hepatic Surgery Versus Conventional Care : a Controlled Randomized Monocentric Trial (MultiPAS).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02715427
• Other study ID #: 2015-A01806-43
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2016
• Last updated: April 1, 2016
• Start date: April 2016

Study information

• Verified date: April 2016
• Source: University Hospital, Angers
• Contact: Emilie Lermite, MD-PhD
• Phone: 02 41 35 36 18
• Email: EmLermite[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Enhanced rehabilitation programs are based on new therapies and treatment combinations to reduce the length of hospitalization, duration of postoperative convalescence, morbidity, but also the overall cost of care. The operating stress and hypercatabolic conditions surrounding the surgery are sources of complications. In this enhanced rehabilitation approach, the principle is to fight through a series of actions against this surgical stress. Several North American studies, Chinese, Scandinavian or Batavian have shown the feasibility and the interest of enhanced perioperative rehabilitation in liver surgery. Nevertheless, there is not until now French data concerning the assessment of enhanced rehabilitation in liver surgery. The main objective of the study is to compare the effectiveness of the implementation of a multimodal management program after liver surgery in a French university center compared to conventional care. Secondary objectives of the study are to compare an enhanced rehabilitation program in liver surgery versus conventional treatment in terms of morbidity and mortality in the immediate postoperative period and until day 90, length of hospital stay, blood loss and the delay to bowel mobility recovery. Compliance to the program in both groups will also be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient to be operated on for hepatectomy in Universitary Hospital of Angers

• No emergency surgery

• No bilio-digestive anastomosis

• Body Mass Index between 18 and 40 kg/m2

• Preoperative morbidity status graded with the American Society of Anesthesiologists (ASA) between I to III

• Affiliated to the national health insurance

Exclusion Criteria:

• Pregnant woman

• Patient who doesn't speack french

• Colorectal surgery combined

• Postoperative stay predictable in critical care unit

• Patient under law protection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Surgery

Intervention

Other:
• Conventional care

• Enhanced recovery

Locations

Country	Name	City	State
France	CHU Angers	Angers	Maine et Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day number to functional recovery	The evaluation of time to functional recovery is scored once a day. A patient is fully functionally recovered when all of the following criteria are satisfied: adequate pain control with oral analgesia: Post-operative pain is rated by the numeric rating scale. Nurses ask patients the intensity of their current pain on a scale of 0 (no pain) to 10 (worst possible pain). To satisfy this criterion, patient must rate their pain between 0 to 3 with only oral analgesics.; restoration of mobility to an independent level We decided to use the Groningen Activity Restriction Scale for rated the difference between preoperative and postoperative mobility level. To satisfy this criterion, patient must have the same score in postoperative.; absence of intravenous fluid administration for at least 24 hours.; ability to eat solid foods well tolerated for at least 24 hours to satisfy this criterion.; normal or decreasing serum bilirubin level and international normalised ratio.	90 days	Yes