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Trial registered on ANZCTR


Registration number
ACTRN12611001190998
Ethics application status
Approved
Date submitted
25/10/2011
Date registered
16/11/2011
Date last updated
16/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of carbon dioxide insufflations in single balloon enteroscopy to determine intubation depth and post procedure pain in patients referred for small bowel examination
Scientific title
Efficacy of carbon dioxide insufflations in single balloon enteroscopy to determine intubation depth and post procedure pain in patients referred for small bowel examination
Secondary ID [1] 273367 0
"Nil"
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
small bowel disease 278987 0
Condition category
Condition code
Oral and Gastrointestinal 279169 279169 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Oral and Gastrointestinal 279337 279337 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure CO2 or air was insufflated during single balloon enteroscopy .CO2 was insufflated using pump UCR Olympus. CO2 was insufflated at a rate of 2 liters per minute. Air was insufflated using the ordinary air inlet system of the endoscope rack. The approximate duration of the intervention in the CO2 group was 42 +/- 15 minutes and the air group was 43 +/- 20 minutes with a mean difference 1+/- 5 minutes, being this was not statistically significant (p = 0.7476).
Mean and standard desviation of the continuous variables were calculated, in the case of nominal variables was calculated frequencies and percentages
The contrasts of continuous variables between groups were based on Student's t test for independent samples, in the case of nominal variables contrasts the X2 test of Pearson was applied, continuity correction was applied in cases where the expected frequencies per cell were less than 5.
Comparisons between groups of continuous variables and nominal variables was performed by using ANOVA of two factors.
A value p <0.05 was considered to be a contrast statistically significant. Data were analyzed by using SPSS 18.
Intervention code [1] 269559 0
Other interventions
Comparator / control treatment
Air was insufflated using the ordinary air inlet system of the endoscope rack .Duration of the procedures in the air group was 43 +/- 20 minutes
Control group
Active

Outcomes
Primary outcome [1] 279807 0
Effects of CO2 and air insufflations on the intubation depth during SBE
Timepoint [1] 279807 0
Each maneuver involving advancement and withdrawal of the whole endoscope system, with blocked balloons, in general allows a maximun of 40 cm of the small bowel to be threaded on. The endoscopist has to estimated the efficacy of insertion of the enteroscope by endoscopic checking of the instruments advancement and has to estimate the length of small bowel released during insertion of the overtube and pulling back of the enteroscope and overtube.
This measurement technique is a standardized form and universally approved
May A, Nachbar L, Ell C. Double balloon enteroscopy (push and pull enteroscopy) of the small bowel : feasibility and diagnostic and therapeutic yield in patients with suspected small bowel disease. Gastrointest Endosc 2005; 62: 62-70.
Secondary outcome [1] 294489 0
Effects of CO2 and air insufflations on post procedure pain during SBE
Timepoint [1] 294489 0
Evaluation of pain and discomfort
Having confirmed that the patients were pain-free before the examination, the patients were asked to grade any pain experienced immediately after the procedure SBE and again at 12 hour after the enteroscopy using a questionnaire containing 100 mm visual analog scale

Eligibility
Key inclusion criteria
We included patients referred for single balloon enteroscopy (SBE) for evaluation of the small bowel with gastrointestinal symptoms
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
intestinal obstruction
pregnancy
morbity obesity
Chronic obstructive bronchopulmonary disease

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each eligible participant was randomized to one of the two treatments groups ( CO2 or air insufflations). Sequence 1:1
Allocation involved contacting the holder of the allocation schedule who was 'off-site' or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each eligible participant was randomized to one of the two treatments groups ( CO2 or air insufflations). Equal randomisation ( 1:1 for two groups)

Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3913 0
Venezuela
State/province [1] 3913 0
Caracas

Funding & Sponsors
Funding source category [1] 270057 0
Hospital
Name [1] 270057 0
Policlinica Metropolitana
Address [1] 270057 0
Avenue Caurimare. El Cafetal. Caracas. Venezuela. 1061
Country [1] 270057 0
Venezuela
Primary sponsor type
Hospital
Name
Policlinica Metropolitana
Address
Avenue Caurimare. El Cafetal. Caracas. Venezuela.1061
Country
Venezuela
Secondary sponsor category [1] 269022 0
None
Name [1] 269022 0
Address [1] 269022 0
Country [1] 269022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272013 0
Ethics Committee Policlinica Metropolitana
Ethics committee address [1] 272013 0
Avenue Caurimare. El Cafetal. Caracas Venezuela.1061
Ethics committee country [1] 272013 0
Venezuela
Date submitted for ethics approval [1] 272013 0
Approval date [1] 272013 0
15/11/2009
Ethics approval number [1] 272013 0

Summary
Brief summary
To evaluate the effect of a gas (carbon dioxide) compared to ambient air in the depth of intubation in the small intestine during an endoscopic procedure used to study diseases of the small intestine (single balloon enteroscopy) and pain after the procedure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33278 0
Address 33278 0
Country 33278 0
Phone 33278 0
Fax 33278 0
Email 33278 0
Contact person for public queries
Name 16525 0
Dias Carla
Address 16525 0
Avenida Libertador. Piso 6. Consultorio 6A. 1051. Caracas
Country 16525 0
Venezuela
Phone 16525 0
+584166093260
Fax 16525 0
+582127621595
Email 16525 0
carladias1969@hotmail.com
Contact person for scientific queries
Name 7453 0
Dias Carla
Address 7453 0
Avenida Libertador. Piso 6. Consultorio 6A. 1051. Caracas
Country 7453 0
Venezuela
Phone 7453 0
+584166093260
Fax 7453 0
Email 7453 0
carladias1969@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary