The Orange III trial: Optimised recovery with Movicol preoperatively within an enhanced recovery programme, a randomised controlled trial

The Orange III trial: Optimised recovery with Movicol preoperatively within an enhanced recovery programme, a randomised controlled trial - Orange III

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003129-92-NL

Enrollment

Registered

2012-03-19

Start date

2012-06-04

Completion date

Unknown

Last updated

2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver resection

Interventions

Trade Name: Movicol Product Name: Movicol Product Code: 208890 Pharmaceutical Form: Solution for infusion and oral solution INN or Proposed INN: Macrogol Other descriptive name: MACROGOL Concentration

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44

Exclusion criteria

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
Main Objective: Enhanced recovery of the gastro-intestinal function after surgery;Secondary Objective: Hospital length of stay and functional recovery;Primary end point(s): Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours;Timepoint(s) of evaluation of this end point: Daily	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Recovery of gastro-intestinal function defined as: a. Time to first stools b. Time to continuous oral intake of clear liquids for more than 24 hours 2. 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 3. Hospital length of stay (nights spent in hospital postoperatively);Timepoint(s) of evaluation of this end point: Daily	—

Measure

Time frame

Secondary end point(s): 1. Recovery of gastro-intestinal function defined as: a. Time to first stools b. Time to continuous oral intake of clear liquids for more than 24 hours 2. 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 3. Hospital length of stay (nights spent in hospital postoperatively);Timepoint(s) of evaluation of this end point: Daily

—

Countries

Netherlands

Contacts

Public ContactLuc Heijnen

MUMC+

luc.heijnen@mumc.nl0031433871997

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026