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
|Condition or disease||Intervention/treatment||Phase|
|Liver Surgery||Other: Conventional care Other: Enhanced recovery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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
- 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:
- 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.
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
|Contact: Emilie Lermite, MD-PhD||02 41 35 36 18||EmLermite@chu-angers.fr|
|Contact: Julien Barbieux, MD||02 41 35 36 18|
|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|