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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01429779
• Other study ID #: 11-1-039
• Status: Recruiting
• Phase: Phase 4
• First received: September 6, 2011
• Last updated: April 10, 2014
• Start date: July 2012

Study information

• Verified date: April 2014
• Source: Maastricht University Medical Center
• Contact: Victor van Woerden, MD
• Phone: +31 43 388 1583
• Email: v.vanwoerden[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitatsklinikum Aachen	Aachen
Netherlands	Maastricht University Hospital	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Norgine

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Recovery of gastro-intestinal function	Recovery of gastro-intestinal function defined as time to continuous oral intake of clear liquids for more than 24 hours	20 days	No
Secondary	Functional recovery	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	20 days	No
Secondary	Hospital length of stay		20 days	No