Capsule Endoscopy as an Alternative to Colonoscopy (CAPSUCOVID)

Hospital Clinic of Barcelona

Status

Enrolling

Conditions

Colonic Disease

Treatments

Device: Pillcam Crohn's Capsule Endoscopy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06031051

CAPSUCOVID

Details and patient eligibility

About

This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.

Full description

Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).

Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria

Enrollment

704 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years
- Rectal bleeding/haematochezia in patients >50 years who have undergone a colonoscopy <5 years ago or <50 years with no risk factors for CRC
- Chronic constipation/abdominal distension/abdominal pain/diarrhea
- Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed
- Recent change in bowel habits
- Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease

Exclusion criteria

Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis
Evaluation following fragmented resection (recurrence ruled out)
Patients with a positive FIT
Pregnancy or breast-feeding
Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.
Allergy or known contraindication to the medications and preparations agents used in the procedure.