Liver Diseases
Conditions
Keywords
General surgery
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.
Interventions
DRUGMovicol
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.
Sponsors
Norgine
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Germany, Netherlands
Contacts
Primary ContactVictor van Woerden, MD
Outcome results
None listed