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

Phase 4

• Conditions: Liver Diseases
• Interventions: Drug: Movicol

• Registration Number: NCT01429779
• Lead Sponsor: Maastricht University Medical Center

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.

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 Timeline

• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Study Start: 2012-07
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-11
• Primary Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Movicol	Movicol	Administration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care).

Primary Outcome Measures

Name	Time	Method
Recovery of gastro-intestinal function	20 days	Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours

Secondary Outcome Measures

Name	Time	Method
Recovery of gastro-intestinal function	20 days	Recovery of gastro-intestinal function defined as time to continuous oral intake of clear liquids for more than 24 hours
Functional recovery	20 days	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	20 days

Trial Locations

Locations (2)

Universitatsklinikum Aachen; 🇩🇪 Aachen, Germany

Maastricht University Hospital; 🇳🇱 Maastricht, Limburg, Netherlands