Clinical trial NCT01429779: The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme
Official title: The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme, a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Diseases
Keywords: General surgery
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Norgine
First posted: 2011-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Recovery of gastro-intestinal function
timeFrame: 20 days
Secondary outcomes:
measure: Recovery of gastro-intestinal function
timeFrame: 20 days
measure: Functional recovery
timeFrame: 20 days
measure: Hospital length of stay
timeFrame: 20 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitatsklinikum Aachen
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
state: Limburg
Study officials:
affiliation: Maastricht University Hospital
name: Ronald M van Dam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Hospital
name: Cornelis H.C. Dejong, MD PHD
role: STUDY_DIRECTOR
References: