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Enhanced Recovery After Hepatic Surgery (MultiPAS). (MultiPAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715427
Recruitment Status : Unknown
Verified April 2016 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : March 22, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Surgery Other: Conventional care Other: Enhanced recovery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhanced Recovery After Hepatic Surgery Versus Conventional Care : a Controlled Randomized Monocentric Trial (MultiPAS).
Study Start Date : April 2016
Estimated Primary Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: Conventional care

Preoperative consultation Information support conventional perioperative No bowel preparation

Day before surgery Normal diet until midnight No carbohydrate loading Premedication with anxiolytic

Operative day Conventional general anaesthesia Classic management perfused volumes Conventional use of drains at the operative site Standard nasogastric drainage Conventional analgesia protocol

Postoperative time Mobilization from J1 Progressive refeeding Progressive removal of venous, arterial and urinary catheters. Gradual recovery of the usual treatment from J1 Breathe physiotherapy depending on the clinical course No stimulation of intestinal transit

Other: Conventional care
Experimental: Enhanced recovery

Preoperative consultation Specific information about the enhanced rehabilitation No bowel preparation Immunonutrition for the 7 preoperative days

Day before surgery Minimal preoperative fasting No premedication Carbohydrate loading

Operative day Optimized general anesthesia Reduced volumes perfused Limiting use of drains at the operative site Reduced doses of morphine Local anesthetic usage No standard use of nasogastric drainage

Postoperative time Stimulation mobilization from D0 Refeeding "on demand " from D0 Early removal of venous, arterial and urinary catheters. J1 recovery from the majority of the usual treatment Breathe physiotherapy from D0 to D5 Ileus prevention by chewing gum

Other: Enhanced recovery



Primary Outcome Measures :
  1. Day number to functional recovery [ Time Frame: 90 days ]

    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:

    1. 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.
    2. 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.
    3. absence of intravenous fluid administration for at least 24 hours.
    4. ability to eat solid foods well tolerated for at least 24 hours to satisfy this criterion.
    5. normal or decreasing serum bilirubin level and international normalised ratio.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715427


Contacts
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Contact: Emilie Lermite, MD-PhD 02 41 35 36 18 EmLermite@chu-angers.fr
Contact: Julien Barbieux, MD 02 41 35 36 18

Locations
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France
CHU Angers Recruiting
Angers, Maine et Loire, France, 49100
Contact: Emilie Lermite, MD-PhD    02 41 35 36 18    EmLermite@chu-angers.fr   
Contact: Julien Barbieux, MD    02 41 35 36 18      
Sponsors and Collaborators
University Hospital, Angers
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02715427    
Other Study ID Numbers: 2015-A01806-43
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: April 2016