Liver SurgeryMultiPASNCT02715427
Enhanced Recovery After Hepatic Surgery (MultiPAS).
A study testing Conventional care and Enhanced recovery in people with Liver Surgery, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Surgery
- What is being tested?
- Conventional care and Enhanced recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant woman
- Patient who doesn't speack french
- Colorectal surgery combined
- Postoperative stay predictable in critical care unit
- Patient under law protection
Trial locations and contacts
1 site in 1 country.
Julien Barbieux, MD contact
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers, Maine et Loire, 49100
Emilie Lermite, MD-PhD, 02 41 35 36 18, EmLermite@chu-angers.fr
Julien Barbieux, MD, 02 41 35 36 18
About this study
Official title: Enhanced Recovery After Hepatic Surgery Versus Conventional Care : a Controlled Randomized Monocentric Trial (MultiPAS).
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.
- Conditions
- Liver Surgery
- Being tested
- Conventional care, Enhanced recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional careOther
Enhanced recoveryOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional care | Active comparator | 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 Receives: Other: Conventional care |
| Enhanced recovery | Experimental | 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 Receives: Other: Enhanced recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715427
- Sponsor's protocol ID
- 2015-A01806-43
- Acronym
- MultiPAS
- Status last verified
- Apr 2016
- First submitted
- 11 Mar 2016
- Last updated
- 4 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Hepatic Surgery Versus Conventional Care : a Controlled Randomized Monocentric Trial (MultiPAS).
- ClinicalTrials.gov ID
- NCT02715427
- Acronym / sponsor ID
- MultiPAS / 2015-A01806-43
- Conditions
- Liver Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (estimated)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional care | Active comparator | Other: Conventional carePreoperative 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 |
| Enhanced recovery | Experimental | Other: Enhanced recoveryPreoperative 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnant woman
- Patient who doesn't speack french
- Colorectal surgery combined
- Postoperative stay predictable in critical care unit
- Patient under law protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional care | Other | Conventional care |
| Enhanced recovery | Other | Enhanced recovery |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Barbieux, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional care and Enhanced recovery in people with Liver Surgery, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Lermite, MD-PhD (02 41 35 36 18, EmLermite@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day number to functional recovery (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.