Enhanced Recovery After Hepatic Surgery (MultiPAS).

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Conventional care

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Enhanced recovery

Intervention Type OTHER

Interventions

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Conventional care

Intervention Type OTHER

Enhanced recovery

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No