Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.
Problem statement:
In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.
Research question/hypothesis:
Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?
Study design:
Parallel group, single blinded randomised controlled trial
Study participants:
Patients attending for colonoscopy under the bowel cancer screening programme
Planned sample size: 534
Planned study period: 12 months
Primary objective:
To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | These patients have standard colonoscopy performed |
|
| Endocuff | Experimental | These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endo-cuff | Device | Colonoscopy performed with endo-cuff attached to the colonoscope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of polyps detected per patient | 1 month (when pathology report available) |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer detection rate | 1 month (when pathology report available) | |
| Polyp detection rate | 1 month (when pathology report available) | |
| Adenomas per patient |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pradeep Bhandari, MBBS, MD, MRCP | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals NHS Trust | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28614895 | Derived | Bhattacharyya R, Chedgy F, Kandiah K, Fogg C, Higgins B, Haysom-Newport B, Gadeke L, Thursby-Pelham F, Ellis R, Goggin P, Longcroft-Wheaton G, Bhandari P. Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial. Endoscopy. 2017 Nov;49(11):1043-1050. doi: 10.1055/s-0043-111718. Epub 2017 Jun 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard colonoscopy |
| Other |
Standard colonoscopy without end-cuff |
|
| 1 month (when pathology report available) |
| Adenoma detection rate | 1 month (when pathology report available) |
| Caecal intubation rate | will be recorded at the time of the procedure | 1 day |
| Total procedure time - from scope insertion to removal | will be recorded at the time of the procedure | 1 day |
| Time taken to reach caecum | will be recorded at the time of the procedure | 1 day |
| Time taken to withdraw scope (from caecum to removal of scope) | will be recorded at the time of the procedure | 1 day |
| Patient comfort score | will be recorded at the time of the procedure | 1 day |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |