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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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22 May 2017 |
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Main ID: |
ISRCTN21973627 |
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Date of registration:
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26/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial)
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Scientific title:
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Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - a prospective, double-blind, multicentre, randomised control trial |
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Date of first enrolment:
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20/06/2011 |
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Target sample size:
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1350 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN21973627 |
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Study type:
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Interventional |
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Study design:
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Randomised; Interventional; Design type: Prevention (Treatment)
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Phase:
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Phase IV
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Laura
Magill |
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Address:
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University of Birmingham
School of Health & Population Sciences
College of Medical and Dental Sciences
Public Health Building
Edgbaston
B15 2TT
Birmingham
United Kingdom |
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Telephone:
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+44 (0)121 4159105 |
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Email:
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e.l.magill@bham.ac.uk |
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Affiliation:
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Name:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All patients undergoing laparoscopic and open colorectal resections for malignant or benign pathology
2. Male & Female; Upper Age Limit 90 years ; Lower Age Limit 18 years
Exclusion criteria: 1. Obstructed procedures
2. Pregnant patients
3. Known adverse reaction to dexamethasone
4. Patients currently taking any form of steroid medication
5. Diabetic/hyperglycaemic patients
6. Active gastric ulceration
7. Wideangle glaucoma
8. Patients under the age of 18
9. Patients unable or unwilling to give informed consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: National Cancer Research Network, Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Colorectal Cancer, Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Colon, Gastrointestinal, Surgery
Surgery
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Intervention(s)
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Patients are randomized between 8 mg intravenous dexamethasone and control (no dexamethasone)
Follow Up Length: 1 month(s)
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Primary Outcome(s)
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Number of episodes of vomiting recorded prospectively 24 hours post-op
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Secondary Outcome(s)
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1. Fatigue measured one month post-op
2. Frequency of use of post-op anti-emetics measured one month post-op
3. Length of hospital stay
4. Subjective measure of PONV measured one month post-op
5. Time to tolerating oral diet measured one month post-op
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Secondary ID(s)
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10426
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2010-022894-32
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Source(s) of Monetary Support
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Bowel Disease Research Foundation, Research for Patient Benefit (RfPB) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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