Colorectal Liver MetastasesORANGENCT00538954
Optimised Recovery With Accelerated Nutrition and GI Enhancement
A study testing Post operative laxation (Magnesium Oxide), Preoperative metabolic conditioning postoperative nutritional supplementation and Standard ERAS group in people with Colorectal Liver Metastases, run by University of Edinburgh at 2 sites in 2 countries.
Trial summary
Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Liver Metastases
- What is being tested?
- Post operative laxation (Magnesium Oxide), Preoperative metabolic conditioning postoperative nutritional supplementation and Standard ERAS group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hepatic resection for benign or malignant conditions
- Able to understand the nature of the study and what will be required of them.
- Men and non-pregnant, non-lactating women
- BMI 18 - 30
Who cannot join
- Inability to give written, informed consent
- Patients with dementia or neurological impairment
- Patients with pre-existing condition limiting mobility
- Planned bile duct excision
- Repeat or staged procedures
- Central extended resections
- Underlying cirrhotic liver disease
- Jaundice (Bilirubin > 50 μmol/L)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support
Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.
- Conditions
- Colorectal Liver Metastases
- Being tested
- Post operative laxation (Magnesium Oxide), Preoperative metabolic conditioning postoperative nutritional supplementation, Standard ERAS group
- Keywords
- Perioperative, recovery, nutrition, enhanced, laxative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post operative laxation (Magnesium Oxide)Drug
20 ml of Magnesium Oxide twice daily from the day after surgery until discharge
Preoperative metabolic conditioning postoperative nutritional supplementationDietary supplement
Nutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30
Standard ERAS groupOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Follow a standard Enhanced Recovery After Surgery protocol Receives: Other: Standard ERAS group |
| 2 | Experimental | Follow a standard Enhanced Recovery After Surgery protocol and will receive 1 g of Magnesium Oxide laxative twice daily from the day after surgery until discharge Receives: Drug: Post operative laxation (Magnesium Oxide) |
| 3 | Experimental | Follow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days Receives: Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation |
| 4 | Experimental | Follow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days and will receive postoperative laxative in the form of 20 ml of Magnesium Oxide twice daily form the day after surgery until discharge Receives: Drug: Post operative laxation (Magnesium Oxide); Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery)
Measured: Number of hours post surgery
Secondary outcomes (3)
t ½ Gastric emptying time on the morning of post-operative day 3
Measured: Postoperative day 3
Length of hospital stay: nights spent in hospital post-op
Measured: Until discharge
Patient activity level: measured by activPAL® activity meter
Measured: postoperative day 2 - 7 and day 30 - 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startAug 2006
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Investigators
- Paul Hendry, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538954
- Sponsor's protocol ID
- UEdinburgh
- Acronym
- ORANGE
- Status last verified
- Oct 2007
- First submitted
- 2 Oct 2007
- Last updated
- 5 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hendry PO, van Dam RM, Bukkems SF, McKeown DW, Parks RW, Preston T, Dejong CH, Garden OJ, Fearon KC; Enhanced Recovery After Surgery (ERAS) Group. Randomized clinical trial of laxatives and oral nutritional supplements within an enhanced recovery after surgery protocol following liver resection. Br J Surg. 2010 Aug;97(8):1198-206. doi: 10.1002/bjs.7120.
PubMed 20602497
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support
- ClinicalTrials.gov ID
- NCT00538954
- Acronym / sponsor ID
- ORANGE / UEdinburgh
- Conditions
- Colorectal Liver Metastases
- Keywords
- Perioperative, recovery, nutrition, enhanced, laxative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Aug 2006
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Standard ERAS groupFollow a standard Enhanced Recovery After Surgery protocol |
| 2 | Experimental | Drug: Post operative laxation (Magnesium Oxide)Follow a standard Enhanced Recovery After Surgery protocol and will receive 1 g of Magnesium Oxide laxative twice daily from the day after surgery until discharge |
| 3 | Experimental | Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementationFollow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days |
| 4 | Experimental | Drug: Post operative laxation (Magnesium Oxide), Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementationFollow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days and will receive postoperative laxative in the form of 20 ml of Magnesium Oxide twice daily form the day after surgery until discharge |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing hepatic resection for benign or malignant conditions
- Able to understand the nature of the study and what will be required of them.
- Men and non-pregnant, non-lactating women
- BMI 18 - 30
Key exclusion criteria (8 listed)
- Inability to give written, informed consent
- Patients with dementia or neurological impairment
- Patients with pre-existing condition limiting mobility
- Planned bile duct excision
- Repeat or staged procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post operative laxation (Magnesium Oxide)20 ml of Magnesium Oxide twice daily from the day after surgery until discharge | Drug | 2, 4 |
| Preoperative metabolic conditioning postoperative nutritional supplementationNutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30 | Dietary supplement | 3, 4 |
| Standard ERAS group | Other | 1 |
Primary outcome
Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery)
Time frame: Number of hours post surgery
3 secondary outcomes
t ½ Gastric emptying time on the morning of post-operative day 3
Time frame: Postoperative day 3
Length of hospital stay: nights spent in hospital post-op
Time frame: Until discharge
Patient activity level: measured by activPAL® activity meter
Time frame: postoperative day 2 - 7 and day 30 - 37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
- Derived from this study: PubMed 20602497Hendry PO, van Dam RM, Bukkems SF, McKeown DW, Parks RW, Preston T, Dejong CH, Garden OJ, Fearon KC; Enhanced Recovery After Surgery (ERAS) Group. Randomized clinical trial of laxatives and oral nutritional supplements within an enhanced recovery after surgery protocol following liver resection. Br J Surg. 2010 Aug;97(8):1198-206. doi: 10.1002/bjs.7120.
Related trials for Colorectal Liver Metastases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Hendry, MBChB principal investigator
University of Edinburgh
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post operative laxation (Magnesium Oxide), Preoperative metabolic conditioning postoperative nutritional supplementation and Standard ERAS group in people with Colorectal Liver Metastases, run by University of Edinburgh at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (time frame: Number of hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2010.