Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial)
| ISRCTN | ISRCTN21973627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21973627 |
| EudraCT/CTIS number | 2010-022894-32 |
| Secondary identifying numbers | 10426 |
- Submission date
- 26/06/2012
- Registration date
- 26/06/2012
- Last edited
- 20/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Laura Magill
Scientific
Scientific
University of Birmingham
School of Health & Population Sciences
College of Medical and Dental Sciences
Public Health Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 4159105 |
|---|---|
| e.l.magill@bham.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Dexamethasone Reduces Emesis After Major gastrointestinal Surgery (DREAMS trial) - a prospective, double-blind, multicentre, randomised control trial |
| Study acronym | DREAMS |
| Study hypothesis | Postoperative nausea and vomiting (PONV) is one of the most common complications affecting patients after major surgery. Patients undergoing bowel surgery are at a relatively high risk of developing these symptoms. This is often multifactorial and such patients are often exposed to various causative agents. Following surgery, patients view nausea and vomiting as a very undesirable effect, often reported as even more unpleasant than pain. It can cause significant consequences and given that over 60,000 bowel operations are performed in the UK annually, PONV is important because of its implications. Although the final outcome of surgery is rarely affected, PONV can cause significant complications such as dehydration, delayed return to oral diet, physiological disturbances and thus prolonging hospital stay. Delayed recovery predisposes to serious and life threatening complications such as hospital acquired pneumonia and thromboembolic events (deep vein thrombosis and pulmonary embolism). The delay in resuming an oral diet affects nutrition and subsequent general well being, predisposing to tissue breakdown, wound infection, fatigue, and weakness. For these reasons, reducing the severity of PONV is particularly important. Dexamethasone is a steroid drug widely but not universally used in attempt to prevent PONV by anaesthetists, and single dose dexamethasone has been reported to reduce PONV and perioperative fatigue. Its precise mechanism of action is unknown but it has antiemetic properties and is known to improve appetite aiding early recovery. Small studies have shown a reduction in PONV amongst patients undergoing various types of surgery who are given dexamethasone. However no multicentre trial has been undertaken. Its potential benefits for patients undergoing bowel surgery need to be investigated. The findings would ensure its appropriate use in the future. |
| Ethics approval(s) | 10/H0402/77; First MREC approval date 16/02/2011 |
| Condition | 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 |
| Intervention | Patients are randomized between 8 mg intravenous dexamethasone and control (no dexamethasone) Follow Up Length: 1 month(s) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Number of episodes of vomiting recorded prospectively 24 hours post-op |
| Secondary outcome measures | 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 |
| Overall study start date | 20/06/2011 |
| Overall study end date | 23/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 950; total number of patients recruited: 1350 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 20/06/2011 |
| Recruitment end date | 31/01/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
University of Birmingham
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
49 sites in the UK
-
United Kingdom
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.bham.ac.uk |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Bowel Disease Research Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BDRF
- Location
- United Kingdom
Research for Patient Benefit (RfPB) (UK)
No information available
Results and Publications
| Intention to publish date | 01/08/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 1. Collaborators across the UK will have the results presented to them 2. Patients will be sent a summary of the results in letter form 3. The main publication of results will be submitted to a major journal 4. The results will be sent to NICE 5. The publication of the results will be available on the University of Birmingham website |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/08/2013 | Yes | No | |
| Results article | results | 18/04/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/04/2017: Publication reference added.
11/08/2015: The following changes were made to the trial record:
1. The original target number of participants (sample size) was 950, however due to the rapid recruitment rate, the power of the trial was increased from 80% to 90%, and the target was thus increased to 1320. The target was reached in January 2014 and the total number of patients recruited was 1350, 6 months ahead of the original end date of July 2014 for only 950 patients.
2. Research for Patient Benefit (RfPB) (UK) was added to the sources of funding.
3. The overall trial end date was changed from 20/06/2014 to 23/07/2015.
