The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Maastricht University Medical Center
Sponsor:
Collaborator:
Norgine
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01429779
First received: September 6, 2011
Last updated: April 10, 2014
Last verified: April 2014

September 6, 2011
April 10, 2014
July 2012
October 2014   (final data collection date for primary outcome measure)
Recovery of gastro-intestinal function [ Time Frame: 20 days ] [ Designated as safety issue: No ]
Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours
Same as current
Complete list of historical versions of study NCT01429779 on ClinicalTrials.gov Archive Site
  • Recovery of gastro-intestinal function [ Time Frame: 20 days ] [ Designated as safety issue: No ]
    Recovery of gastro-intestinal function defined as time to continuous oral intake of clear liquids for more than 24 hours
  • Functional recovery [ Time Frame: 20 days ] [ Designated as safety issue: No ]

    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
  • Hospital length of stay [ Time Frame: 20 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Liver Diseases
Drug: Movicol
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.
  • Experimental: Movicol
    Administration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care).
    Intervention: Drug: Movicol
  • No Intervention: Control
    Control group; standard postoperative care (administration of 2 sachets of Movicol® postoperatively daily)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Victor van Woerden, MD +31 43 388 1583 v.vanwoerden@maastrichtuniversity.nl
Netherlands,   Germany
 
NCT01429779
11-1-039
Yes
Maastricht University Medical Center
Maastricht University Medical Center
Norgine
Principal Investigator: Ronald M van Dam, MD Maastricht University Hospital
Study Director: Cornelis H.C. Dejong, MD PHD Maastricht University Hospital
Maastricht University Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP