The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol®.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is recovery of gastro-intestinal function defined as time to
continuous intake of solid food for more than 24 hours.
Secondary outcome
Secondary outcomes are recovery of gastro-intestional function defined as time
to first stools and time to continuous oral intake of clear liquids for more
than 24 hours, functional recovery and hospital length of stay.
Background summary
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.
Study 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.
Intervention
Patients randomised in group A receive once daily a sachet Movicolon®/Movicol®
one week prior to partial liver resection. These patients should follow normal
diet and are allowed to use prescribed co-medication in accordance to ERAS®
protocols. Patients randomised in group B will not receive this daily sachet
Movicolon®/Movicol® prior to liver surgery. As for Movicolon®/Movicol®
postoperatively, both groups follow ERAS® protocols.
Study burden and risks
As the intervention (open partial liver resection) is well known and performed
adequately and safely on a regular base, the burden and risks associated with
participation in the trial are comparable with patients who are not
participating in this trial. We foresee no risks associated with the
investigational product. The benefits are an early return of gastro-intestinal
function and thus an accelerated recovery of physical function and a decrease
in risks of gastro-intestinal complications.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- 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 (including gastrojejunostomy)
- Participation in the ORANGE 2 trial
- Daily use of laxatives such as Movicolon®/Movicol®.
- Having diarrhea
- Hypersensitivety Movivolon
- Laparoscopic resection
- Concomitant HIPEC treatment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-003129-92-NL |
| ClinicalTrials.gov | NCT01429779 |
| CCMO | NL38131.068.11 |