Patients undergoing nausea and vomiting following elective colorectal resections
Conditions
Interventions
Trade Name: The dexamethasone used is in the protocol allows any brand with a MA in the UK to be used, e.g. Dexamethasone 4mg/ml or 3.3mg/ml Injection. That named below is an example.
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients undergoing laparoscopic and open colorectal resections for malignant or benign pathology. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. Wide-angle glaucoma 8. Patients under the age of 18 9. Patients unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The DREAMS trial is a 2 stage study: i) a feasibility study and ii) a phase IV randomsied controlled trial. The objective of the feasibility study is to assess the feasibility of running the phase IV study. This pilot trial will develope effective strategies for patient identification, recruitment and follow-up in the main part of the trial. The objective of the full trial is to determine whether dexamethasone reduces postoperative nausea and vomiting in patients undergoing planned major bowel surgery and to determine it's role in future use in this category of patients.;Secondary Objective: The secondary objective of the phase IV trial is to determine whether there is a measurable benefit during recovery with the use of single dose dexamethasone. Benefits investigated will include quicker return to oral diet and reduced length of stay. The following secondary outcomes will be measured post-operatively. 1. Nausea and vomiting will be measured objectively by recording the frequency of use of post-operative anti-emetics. 2. Nausea will also be measured subjectively by the use of validated visual analogue scale (VAS). 3. Fatigue will be measured using a validated assessment score (FACT – Fatigue questionnaire). 4. Time to tolerate oral diet will be recorded. 5. Length of hospital stay. 6. Health-related quality of life (Euroqol EQ-5D) will be measured using a standardised questionaire. 7. Incremental cost-effectiveness of dexamethasone compared to standard care will also be measured. 8. As we will be using a steroid, we will evaluate patients for increased risks o;Primary end point(s): 1. Episodes of vomiting recorded prospectively on patient care charts. | — |
Countries
United Kingdom
Outcome results
None listed