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

This study is not yet open for participant recruitment.
Verified September 2011 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: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Diseases
 Drug: Movicol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme, a Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Movicol
Administration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care).
 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.
No Intervention: Control
Control group; standard postoperative care (administration of 2 sachets of Movicol® postoperatively daily)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429779

Contacts
Contact: Toine M. Lodewick, MD +31 43 387 1997 t.lodewick@student.maastrichtuniversity.nl

Locations
Germany
Universitatsklinikum Aachen Not yet recruiting
Aachen, Germany, 52074
Contact: Maximilian Schmeding, MD     0049-241-8037073     mschmeding@ukaachen.de    
Netherlands
Maastricht University Hospital Not yet recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Toine M. Lodewick, MD     +31 43 387 1997     t.lodewick@student.maastrichtuniversity.nl    
Sponsors and Collaborators
Maastricht University Medical Center
Norgine
Investigators
Principal Investigator: Ronald M van Dam, MD Maastricht University Hospital
Study Director: Cornelis H.C. Dejong, MD PHD Maastricht University Hospital
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01429779     History of Changes
Other Study ID Numbers: 11-1-039
Study First Received: September 6, 2011
Last Updated: September 26, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
General surgery

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013