The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme
1 other identifier
interventional
80
2 countries
2
Brief 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 recovery by promoting early return of gastro-intestinal function, defined as the passage of stools and early oral intake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedApril 11, 2014
April 1, 2014
2.3 years
September 6, 2011
April 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
20 days
Secondary Outcomes (3)
Recovery of gastro-intestinal function
20 days
Functional recovery
20 days
Hospital length of stay
20 days
Study Arms (2)
Movicol
EXPERIMENTALAdministration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care).
Control
NO INTERVENTIONControl group; standard postoperative care (administration of 2 sachets of Movicol® postoperatively daily)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Norginecollaborator
Study Sites (2)
Universitatsklinikum Aachen
Aachen, 52074, Germany
Maastricht University Hospital
Maastricht, Limburg, 6202 AZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald M van Dam, MD
Maastricht University Hospital
- STUDY DIRECTOR
Cornelis H.C. Dejong, MD PHD
Maastricht University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2011
First Posted
September 7, 2011
Study Start
July 1, 2012
Primary Completion
October 1, 2014
Last Updated
April 11, 2014
Record last verified: 2014-04