The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme
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|ClinicalTrials.gov Identifier: NCT01429779|
Recruitment Status : Unknown
Verified April 2014 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : September 7, 2011
Last Update Posted : April 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Diseases||Drug: Movicol||Phase 4|
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.
The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol®
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme, a Randomised Controlled Trial|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||October 2014|
Administration of 1 sachet of Movicol® daily during one week preoperatively (experimental care) and 2 sachets of Movicol® daily postoperatively (standard care).
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.
No Intervention: Control
Control group; standard postoperative care (administration of 2 sachets of Movicol® postoperatively daily)
- Recovery of gastro-intestinal function [ Time Frame: 20 days ]Recovery of gastro-intestinal function defined as time to first intake of solid food continued for more than 24 hours
- Recovery of gastro-intestinal function [ Time Frame: 20 days ]Recovery of gastro-intestinal function defined as time to continuous oral intake of clear liquids for more than 24 hours
- Functional recovery [ Time Frame: 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 [ Time Frame: 20 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429779
|Contact: Victor van Woerden, MD||+31 43 388 firstname.lastname@example.org|
|Aachen, Germany, 52074|
|Contact: Maximilian Schmeding, MD 0049-241-8037073 email@example.com|
|Maastricht University Hospital||Recruiting|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Contact: Victor van Woerden, MD +31 43 388 1583 firstname.lastname@example.org|
|Principal Investigator:||Ronald M van Dam, MD||Maastricht University Hospital|
|Study Director:||Cornelis H.C. Dejong, MD PHD||Maastricht University Hospital|