Colorectal Cancer Clinical Trial
— 5GSUCCEEDSOfficial title:
5G SUCCEEDS Trial Feasibility of Home Delivery of Colon Capsule Endoscopy Service With the Help of 5 G Technology
Patients without alarming symptoms are at low risk of bowel cancer . However, in majority of those patients colonoscopy (gold standard) is needed to diagnose colorectal cancer or other non-neoplastic conditions such as Inflammatory bowel disease . Evaluation of patients with lower gastrointestinal symptoms ( low-intermediate risk group) represent significant pressure for colonoscopy services . At the end of August 2019 there were a total 44,388 patients still waiting for colonoscopy. Covid 19 pandemic has placed significant pressure on healthcare systems since March 2020.The aerosol generating potential of endoscopy has led to multiple Gastroenterology and Endoscopy societies suggesting immediate cessation of all but emergency colonoscopy during the peak phase of the pandemic which put colonoscopy capacity even more under pressure Data from the National Endoscopy Database indicate that total endoscopic activity fell rapidly to 5% of normal levels during the peak phase of the COVID-19 epidemic in the UK (from approximately 35 000 reported procedures per week to 1700, for the week ending 13 April . In order to reduce potential diagnostic delays as a result of COVID pandemic , the role of colon capsule endoscopy (CCE) as a non invasive diagnostic test is being increasingly recognise, which allows for a pain-free colonic assessment by eliminating the need for instrument insertion, gas insufflation or sedation . The aim of the 5G SUCCEEDS study is to trial feasibility of home delivery of Colon Capsule Endoscopy service with the help of 5 G technology. Currently patients need to attend hospital to access this service.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | August 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Patients who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care - Age between 18-55 Exclusion Criteria: - Patients unable or unwilling to provide consent to take part in the study - Patient is pregnant - Standard CCE exclusion criteria |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Gohar jalayeri Nia | Coventry | West Midlands |
Lead Sponsor | Collaborator |
---|---|
National Health Service, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of home delivery of CCE service | To assess the feasibility of Colon Capsule Endoscopy home delivery service, we followed a structured approach. We are aiming to deliver the whole CCE service at home by using a smartbox, 5G technology and telemedicine communication to conduct the study and troubleshoot any upcoming issues. The target population is based on the number of available smartboxes. Through a comprehensive process we obtained all the regulatory and ethical approval for conducting the study | 12month | |
Secondary | assessing the patient's acceptability of home delivery of CCE service | One of the main aims of this study is to measure the patient' satisfaction. We design the questionnaire to capture the necessary information. We wanted to include factors such as quality of care, experience with using the capsule endoscopy equipment and smartbox at home, and overall experience. Format of the questionnaire is mainly structured with closed-ended questions (multiple-choice or Likert scale. When we are using a scale from 0 to 5, 0 represents extremely easy and 5 represents extremely difficult. Based on our identified domains, we develop specific questions that assess patient satisfaction within each domain, and we ensure that the questions are clear, concise, and unambiguous and we avoided leading or biased questions that may influence the responses. | 6 month |
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