Capsule Endoscopy as an Alternative to Colonoscopy (CAPSUCOVID)

Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?

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.

Study Overview

• Status: Recruiting
• Conditions: Colonic Disease
• Intervention / Treatment: Device: Pillcam Crohn's Capsule Endoscopy

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 704
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BEGOÑA GONZALEZ SUAREZ, MD, PhD; Phone Number: +34661334362; Email: bgonzals@clinic.cat
• Study Contact Backup: Name: Miguel Urpí Ferreruela, MD; Email: murpi@recerca.clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic of Barcelona
    • Contact: BEGOÑA GONZALEZ SUAREZ; Phone Number: +34661334362; Email: bgonzals@clinic.cat
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital Sant Pau
    • Contact: Cristina Romero Mascarell, MD; Email: cromerom@santpau.cat
  • Terrassa, Spain
    • Recruiting
    • Hospital Mutua De Terrassa
    • Contact: Montserrat Aceituno Quintanilla; Email: maceituno@mutuaterrassa.es
  • Canarias
    • Santa Cruz De Tenerife, Canarias, Spain
      • Recruiting
      • Hospital universitario de Santa Cruz de Tenerife
      • Contact: Antonio Zebenzuy Gimeno-García; Email: antozeben@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pillcam Crohn's Capsule Endoscopy and colonoscopy; All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy	Device: Pillcam Crohn's Capsule Endoscopy; Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy; Other Names: Pillcam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients who could avoid colonoscopy	To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CE diagnostic yield and adenoma detection rate (ADR)	Number of adenoma detected by CE	6 months
To compare CE and CC findings	Compare findings between both techniques	6 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Medtronic
• Investigators: Principal Investigator: BEGOÑA GONZALEZ SUAREZ, MD PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: CAPSUCOVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No