Colo-rectal Cancer Clinical Trial
Official title:
Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.
Verified date | October 2020 |
Source | Region Örebro County |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The number of endoscopies performed varies greatly between different countries and does not
reflect variations in disease incidents. The costs of unnecessary endoscopies are significant
and with a better selection of which patients need to be examined with endoscopy, resources
could be saved in healthcare, and a better triage would mean that malignancies and other more
serious conditions do not have to wait. An example of unnecessary endoscopy is a colonoscopy
in patients with irritable bowel syndrome or gastroscopy in patients with functional
dyspepsia.
The purpose of the project is, among other things:
- What diagnostic benefit have gastroscopy, colonoscopy, capsule endoscopy and double
balloon enteroscopy for different indications in different age groups?
- What are the risks of this type of examination?
- Can patients be better selected based on symptoms, psychometric data or laboratory
findings to reduce the number of unnecessary examinations and prioritize those that
should be scooped up first?
- Can changed calling methods reduce the number of late cancellations and rebookings and
missed patients?
Status | Active, not recruiting |
Enrollment | 5000 |
Est. completion date | January 2028 |
Est. primary completion date | January 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: All patients who underwent a diagnostic diagnostic procedure at the endoscopy unit at the University Hospital Örebro. Exclusion Criteria: Patients <18 years |
Country | Name | City | State |
---|---|---|---|
Sweden | University hospital | Örebro | Egion Rebro Ounty |
Lead Sponsor | Collaborator |
---|---|
Region Örebro County |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient characteristics in patients who were admitted for colonoscopy 1 | proportion of patients with weight loss >10% | September 2016 - December 2018 | |
Other | Patient characteristics in patients who were admitted for colonoscopy 2 | age | September 2016 - December 2018 | |
Other | Patient characteristics in patients who were admitted for colonoscopy 3 | male/female | September 2016 - December 2018 0 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 1 | proportion of patients with loose stools | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 2 | proportion of patients with constipation | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 3 | proportion of patients with altered bowel function specified | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 4 | proportion of patients with abnormal radiology | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 5 | proportion of patients with abnormal rectal examination | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 6 | proportion of patients with rectal bleeding without obvious source | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 7 | proportion of patients with rectal bleeding despite adequate treatment | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 8 | proportion of high-risk patients with rectal bleeding | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 9 | proportion of patients with anemia of unknown cause | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 10 | proportion of patients with positive fecal occult blood test | September 2016 - December 2018 | |
Other | symptom characteristics in patients who were admitted for colonoscopy 11 | proportion of patients with increased fecal calprotectin | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 1 | Proportion of patients with polyps high-grade/low grade dysplasia | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 2 | Proportion of patients with diverticulosis | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 3 | Proportion of patients with inflammation unspecified | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 4 | Proportion of patients with IBD | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 5 | Proportion of patients with infectious colitis | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 6 | Proportion of patients with microscopic colitis | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 7 | Proportion of patients with diverticulitis | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 8 | Proportion of patients with hemorrhoids | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 9 | Proportion of patients with angiodysplasia | September 2016 - December 2018 | |
Other | Endoscopic finding in patients who were admitted for colonoscopy 10 | Proportion of patients with no findings. | September 2016 - December 2018 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 1 | proportion of patients with weight loss >10% | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 2 | proportion of patients with loss of appetite | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 3 | proportion of patients with dysphagia | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 4 | proportion of patients with vomiting | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 5 | proportion of patients with jaundice | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 6 | proportion of patients with GERD/oesofagitis | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 7 | proportion of patients with gastritis | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 8 | proportion of patients with peptic ulcer disease | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 9 | proportion of patients with dysplasia/cancer | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 10 | proportion of patients with IBD | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 11 | proportion of patients with celiac disease | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 12 | proportion of patients who meet Rome IV criteria for functional dyspepsia. | Jan 2019-April 2020 | |
Other | Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 13 | proportion of patients with other unspecified pathology | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 1 | male/female | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 2 | proportion of patients who smoke | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 3 | proportion of patients with age 18-29, age 30-39, age 40-49. | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 4 | proportion of patients using NSAIDs/ASA | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 5 | proportion of patients who had done a h. pylori test | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 6 | proportion of patients with a positive h. pylori test | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 7 | proportion of patients who were eradicated after a positive h. pylori test | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 8 | ethnicity of patients (proportion caucasian origin, African origin, arabic origin, asian origin) | Jan 2019-April 2020 | |
Other | Patients characteristics in patients < 50 years who were admitted for a gastroscopy 9 | days between referral and gastroscopy | Jan 2019-April 2020 | |
Primary | All confirmed colorectal cancer cases that were diagnosed via colonoscopy. | The proportion of patients that was admitted to the department of surgery with confirmed colorectal cancer, diagnosed according to the standardized course of care for colorectal cancer. | between September 2016 and December 2018 | |
Primary | Proportion of patients that was diagnosed with colorectal cancer. with colorectal cancer | All patients that were admitted to the endoscopy unit according to the standardized course of care for colorectal cancer. | between September 2016 and December 2018 | |
Primary | Presence of upper GI pathology | The proportion of upper GI pathology in all patients <50 years who were admitted for a gastroscopy | between Jan 2019-April 2020 | |
Secondary | route of colorectal cancer diagnosis 1 | The proportion of patients with confirmed colorectal cancer that was diagnosed with colonoscopy according to the standardized chain of care for colorectal cancer. | January 2016 and December 2018 | |
Secondary | route of colorectal cancer diagnosis 2 | The proportion of patients with confirmed colorectal cancer that was diagnosed with routine colonoscopy. | January 2016 and December 2018 | |
Secondary | Localization of colorectal cancer | The site of the tumor in confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | tumor characteristics of colorectal cancer 1 | The stage of the tumor in confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | tumor characteristics of colorectal cancer 2 | The histology of the tumor in confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | symptom characteristics of colorectal cancer 1 | proportion of patients with changes in bowel habits >4 weeks in patients with confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | symptom characteristics of colorectal cancer 2 | proportion of patients with radiology in patients with confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | symptom characteristics of colorectal cancer 3 | proportion of patients with abnormal rectal finding via palpation or rectoscopy in patients with confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | symptom characteristics of colorectal cancer 4 | proportion of patients with rectal bleeding without obvious source in patients with confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | symptom characteristics of colorectal cancer 5 | proportion of patients with rectal bleeding despite adequate treatment of bleeding source in patients with confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | symptom characteristics of colorectal cancer 6 | proportion of patients with rectal bleeding in high-risk patients with confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | symptom characteristics of colorectal cancer 7 | proportion of patients with bleeding anemia of unknown source in patients with confirmed colorectal cancer | January 2016 and December 2018 | |
Secondary | patient characteristics of colorectal cancer 1 | male/female | January 2016 and December 2018 | |
Secondary | patient characteristics of colorectal cancer 2 | age | January 2016 and December 2018 | |
Secondary | patient characteristics of colorectal cancer 3 | hemoglobine value | January 2016 and December 2018 | |
Secondary | patient characteristics of colorectal cancer 4 | calprotectin value | January 2016 and December 2018 | |
Secondary | patient characteristics of colorectal cancer 5 | Days between referral and colonoscopy | January 2016 and December 2018 | |
Secondary | patient characteristics of colorectal cancer 6 | referral from primary health care yes/no | January 2016 and December 2018 | |
Secondary | patient characteristics of colorectal cancer 7 | referral year: 2017/2017/2018 | January 2016 - December 2018 |
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