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

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Phase 4

Conditions: Liver Diseases

Treatments: Drug: Movicol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01429779

11-1-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Movicol

Experimental group

Description:

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

Treatment:

Drug: Movicol

Control

No Intervention group

Description:

Control group; standard postoperative care (administration of 2 sachets of Movicol® postoperatively daily)