Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000984897
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
27/07/2021
Date last updated
14/12/2022
Date data sharing statement initially provided
27/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Yield of same day dual endoscopy for patients referred for assessment of positive Fecal Occult Blood Test.
Scientific title
Effect of same day dual endoscopy on frequency of common gastrointestinal conditions and gastrointestinal symptoms for patients referred for assessment of positive Fecal Occult Blood Test.
Secondary ID [1] 303953 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer screening 321548 0
Upper gastrointestinal tract pathology 321549 0
Gastric and esophageal cancers 321550 0
Peptic ulcer disease 321551 0
Celiac disease 322107 0
Iron deficiency anemia 322108 0
Condition category
Condition code
Cancer 319296 319296 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 319297 319297 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 319298 319298 0 0
Bowel - Small bowel (duodenum and ileum)
Blood 319299 319299 0 0
Anaemia
Cancer 319822 319822 0 0
Stomach
Inflammatory and Immune System 320324 320324 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study has a prospective and a retrospective component. This study is single center study, which will be conducted at the Gastroenterology department at the Princess Alexandra hospital. For the retrospective component, we will audit all patient records who have undergone Gastroscopy and Colonoscopy on the same day for investigation of positive FOBT from Jan 2010 until July 2019.
Gastroscopy which will take approximately 10 mins will be done on the same day as the colonoscopy (either immediately before or after the colonoscopy). There will be no additional anesthesia or observation required for the gastroscopy. Both colonoscopy and gastroscopy will be performed by a gastroenterologist. Patients will not be required to fill additional questionnaire or have phone interviews.
The retrospective part of the study will involve reviewing electronic medical records to collect information (demographic details including age, sex, BMI, ethnicity, medications, co-morbidities, outcomes of gastroscopy and colonoscopy, quality of bowel preparation, laboratory data (Full blood count, celiac serology, Iron studies and Helicobacter pylori status)) for patients who have undergone same day gastroscopy and colonoscopy.
The participants would have undergone this screening procedure in the absence of this study
Intervention code [1] 320263 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327178 0
1. To assess the frequency of common gastrointestinal conditions (namely IDA and Celiac disease) and gastrointestinal symptoms in patients referred for evaluation of positive FOBT. This is a composite primary outcome and this will be assessed from endoscopy.
Timepoint [1] 327178 0
To be assessed on the day of the procedure
Secondary outcome [1] 394079 0
2. To determine the frequency of both upper and lower intestinal lesions in asymptomatic FOBT-positive patients and those with gastrointestinal symptoms.
This is a composite secondary outcome and will be assessed from the endoscopy.
Timepoint [1] 394079 0
To be assessed on the day of the procedure

Eligibility
Key inclusion criteria
All patients referred for investigation of positive FOBT will be considered for participation in study.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Using SPSS, compare frequency of UGI lesions in patients with negative and positive findings on the colonoscopy, using parametric tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
800
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19175 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 33747 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 308335 0
Hospital
Name [1] 308335 0
Princess Alexandra Hospital
Country [1] 308335 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Department of Gastroenterology and Hepatology,
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 309150 0
None
Name [1] 309150 0
NA
Address [1] 309150 0
NA
Country [1] 309150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308310 0
Metro South HREC
Ethics committee address [1] 308310 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Ethics committee country [1] 308310 0
Australia
Date submitted for ethics approval [1] 308310 0
14/03/2019
Approval date [1] 308310 0
18/10/2019
Ethics approval number [1] 308310 0

Summary
Brief summary
This study will investigate the effect of same day dual endoscopy on finding common gastrointestinal conditions for patients referred for assessment of positive Fecal Occult Blood Test (Bowel cancer screening test)

Who is it for?
You may be eligible to join this study if you are aged 50 and above, and have been referred for investigation of positive Fecal Occult Blood Test (Bowel cancer screening test)

Study details:
All participants in this study will have two endoscopy procedures on the same day: an upper (gastroscopy) and lower (colonoscopy) as part of the routine clinical care for patients with a positive fecal occult blood test. We would also access your electronic medical records so we can confirm your diagnosis and test results. The findings from both upper and lower endoscopy will be used to evaluate occult GI bleeding.

Participants will not be asked to attend any additional appointments, outside their scheduled clinical visits. This study therefore has no effect and no foreseeable risk of harm to its participants. No attempts at directly contacting the patient or their family will be made. All the relevant findings from the endoscopy (both gastroscopy and colonoscopy) will be discussed with the participants by their gastroenterologist.

It is hoped these findings will provide further guidance/evidence to support the routine use of both upper and lower endoscopy for the evaluation of occult GI bleeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110258 0
Prof Gerald Holtmann
Address 110258 0
Department of Gastroenterology
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 110258 0
Australia
Phone 110258 0
+61 400107754
Fax 110258 0
Email 110258 0
[email protected]
Contact person for public queries
Name 110259 0
Prof Gerald Holtmann
Address 110259 0
Department of Gastroenterology
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 110259 0
Australia
Phone 110259 0
+61 400107754
Fax 110259 0
Email 110259 0
[email protected]
Contact person for scientific queries
Name 110260 0
Prof Gerald Holtmann
Address 110260 0
Department of Gastroenterology
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 110260 0
Australia
Phone 110260 0
+61 400107754
Fax 110260 0
Email 110260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics requirement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.