Liver DiseasesPhase 4NCT01429779
The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme
A Phase 4 study testing Movicol in people with Liver Diseases, run by Maastricht University Medical Center at 2 sites in 2 countries.
Trial summary
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol. Hypothesis The use of Movicol® during one week prior to partial liver resection combined with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Movicol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to Oct 2014
- Phase
- Phase 4
- 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
- Patients undergoing a partial liver resection
- Able to understand the nature of the study and what will be required of them
- Men and non-pregnant, non-lactating women between age 18-80
- BMI between 18-35
- Patients with ASA I-III
Who cannot join
- Inability to give written informed consent
- Patients requiring bile duct reconstruction
- Patients with ASA IV-V
- Superextended hepatectomy
- Underlying symptomatic liver disease such as cirrhosis
- Underlying gastro-intestinal disease such as motility disorders
- Need for procedures additive to partial liver resection
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Universitatsklinikum Aachen
Aachen, 52074
Maximilian Schmeding, MD, 0049-241-8037073, mschmeding@ukaachen.de
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Hospital
Maastricht, Limburg, 6202 AZ
Victor van Woerden, MD, +31 43 388 1583, v.vanwoerden@maastrichtuniversity.nl
About this study
Official title: The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme, a Randomised Controlled Trial
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol.
Hypothesis The use of Movicol® during one week prior to partial liver resection combined with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by promoting early return of gastro-intestinal function, defined as the passage of stools and early oral intake.
Read the detailed description
Rationale:
The routine use of laxatives after liver surgery as part of an Enhanced Recovery After Surgery (ERAS®) programme enhances recovery of gastro-intestinal function and early tolerance of oral nutrition. The use of Macrogol (Movicol®) as laxative during one week prior to partial liver resection will further enhance early return of gastro-intestinal function and accelerate functional recovery.
Objective:
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol®
Study design:
The Orange-III trial is a multicentre randomised controlled trial to aim whether the administration of 1 sachet of Movicol® during one week preoperatively and 2 sachets of Movicol® postoperatively will further enhance early recovery compared to the administration of 2 sachets of Movicol® postoperatively only, following liver surgery. All patients will be managed within an ERAS® programme of perioperative care.
Study population:
Patients requiring a partial liver resection (two or more segments), 18-80 yr old.
Main study parameters/endpoints:
The main objective of the Orange-III trial is to provide evidence on early recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours after the use of Movicol® during one week prior to partial liver resection within an enhanced recovery programme. Secondary objectives are recovery of gastro-intestinal function defined as time to first stools and time to continuous intake of clear fluids for more than 24 hours, functional recovery, hospital length of stay and patient activity level.
- Conditions
- Liver Diseases
- Being tested
- Movicol
- Keywords
- General surgery
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MovicolDrug
Movicol® in sachets of 13,81 gram each. One sachet consists of 13,125 gr Macrogol 3350, 178,5 mg Sodium bicarbonate, 350,7 mg Sodium chloride and 46,6 mg Potassium chloride. Administration of 1 sachet of Movicol® daily during one week preoperatively and 2 sachets of Movicol® daily postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Movicol | Experimental | Administration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care). Receives: Drug: Movicol |
| Control | No intervention | Control group; standard postoperative care (administration of 2 sachets of Movicol® postoperatively daily) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of gastro-intestinal function
Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours
Measured: 20 days
Secondary outcomes (3)
Recovery of gastro-intestinal function
Recovery of gastro-intestinal function defined as time to continuous oral intake of clear liquids for more than 24 hours
Measured: 20 days
Functional recovery
Functional recovery (measured by the following functional recovery criteria)
- Adequate pain control on oral analgesics only
- Eating and drinking properly without the need of IV fluids
- Independently mobile or mobile at preoperative level
- Standard laboratory tests and liver function returning to normal level
Measured: 20 days
Hospital length of stay
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJul 2012
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Norgine
- Responsible party
- Sponsor
- Investigators
- Ronald M van Dam, MD, Principal investigator, Maastricht University HospitalCornelis H.C. Dejong, MD PHD, Study director, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429779
- Sponsor's protocol ID
- 11-1-039
- Status last verified
- Apr 2014
- First submitted
- 6 Sep 2011
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01429779
- Acronym / sponsor ID
- 11-1-039
- Conditions
- Liver Diseases
- Keywords
- General surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Norgine
- Study start
- Jul 2012
- Primary completion
- Oct 2014 (estimated)
- First posted
- 7 Sep 2011 (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.
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol.
Hypothesis The use of Movicol® during one week prior to partial liver resection combined with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by promoting early return of gastro-intestinal function, defined as the passage of stools and early oral intake.
Detailed description
Rationale:
The routine use of laxatives after liver surgery as part of an Enhanced Recovery After Surgery (ERAS®) programme enhances recovery of gastro-intestinal function and early tolerance of oral nutrition. The use of Macrogol (Movicol®) as laxative during one week prior to partial liver resection will further enhance early return of gastro-intestinal function and accelerate functional recovery.
Objective:
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol®
Study design:
The Orange-III trial is a multicentre randomised controlled trial to aim whether the administration of 1 sachet of Movicol® during one week preoperatively and 2 sachets of Movicol® postoperatively will further enhance early recovery compared to the administration of 2 sachets of Movicol® postoperatively only, following liver surgery. All patients will be managed within an ERAS® programme of perioperative care.
Study population:
Patients requiring a partial liver resection (two or more segments), 18-80 yr old.
Main study parameters/endpoints:
The main objective of the Orange-III trial is to provide evidence on early recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours after the use of Movicol® during one week prior to partial liver resection within an enhanced recovery programme. Secondary objectives are recovery of gastro-intestinal function defined as time to first stools and time to continuous intake of clear fluids for more than 24 hours, functional recovery, hospital length of stay and patient activity level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Movicol | Experimental | Drug: MovicolAdministration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care). |
| Control | No intervention | –Control group; standard postoperative care (administration of 2 sachets of Movicol® postoperatively daily) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing a partial liver resection
- Able to understand the nature of the study and what will be required of them
- Men and non-pregnant, non-lactating women between age 18-80
- BMI between 18-35
- Patients with ASA I-III
Key exclusion criteria (7 listed)
- Inability to give written informed consent
- Patients requiring bile duct reconstruction
- Patients with ASA IV-V
- Superextended hepatectomy
- Underlying symptomatic liver disease such as cirrhosis
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 |
|---|---|---|
| MovicolMovicol® in sachets of 13,81 gram each. One sachet consists of 13,125 gr Macrogol 3350, 178,5 mg Sodium bicarbonate, 350,7 mg Sodium chloride and 46,6 mg Potassium chloride. Administration of 1 sachet of Movicol® daily during one week preoperatively and 2 sachets of Movicol® daily postoperatively. | Drug | Movicol |
Primary outcome
Recovery of gastro-intestinal function
Time frame: 20 days
Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours
3 secondary outcomes
Recovery of gastro-intestinal function
Time frame: 20 days
Functional recovery
Time frame: 20 days
Hospital length of stay
Time frame: 20 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
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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.
Ronald M van Dam, MD principal investigator
Maastricht University Hospital
Cornelis H.C. Dejong, MD PHD study director
Maastricht University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Movicol in people with Liver Diseases, run by Maastricht University Medical Center at 2 sites in 2 countries.
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 5 inclusion and 7 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Victor van Woerden, MD (+31 43 388 1583, v.vanwoerden@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of gastro-intestinal function (time frame: 20 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 11 Apr 2014.