CUFF-assisted Colonoscopy vs Standard Colonoscopy

NCT03758872 | Completed DMC

• 1 other identifier: 2018-A01397-48
• Study Type: observational
• Target: 1,034
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy. This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group

Conditions

Colonic Polyp; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• detection of polyp or adenoma with cuff

  during procedure

Secondary Outcomes (5)

• POLYP DETECTION RATE

  during procedure

• morbidity : perforation rate

  21 DAYS AFTER PROCEDURE

• CAECAL INTUBATION RATE

  DURING PROCEDURE

• TIME TO REACH CAECUM

  DURING PROCEDURE

• WITHDRAWAL TIME

  DURING PROCEDURE

Study Arms (1)

historical comparaison whithout cuff

517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection

Diagnostic Test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)

Interventions

cuff assisted colonoscopy(with cuff use of endocuff vision second generation) DIAGNOSTIC_TEST

this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps

Also known as: colonoscopy with polypectomy or mucosectomy, standard colonoscopy ( without use of endocuff vision)

historical comparaison whithout cuff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient of all participating physicians for total colonoscopic exploration over the study periods

You may qualify if:

• Patient scheduled for total colonoscopic exploration, during the period study
• Patient over or equal to 18 years
• ASA 1, ASA 2, ASA 3
• No participation in another clinical study
• Certificate of non opposition signed

You may not qualify if:

• Patient under 18 years old
• ASA 4, ASA 5
• Pregnant woman
• Patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, -Platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
• Inflammatory bowel disease
• Known colonic stenosis
• Diverticulitis less than 6 weeks old
• Patient unable to give consent or protected by law

Sponsors & Collaborators

• Clinique du Trocadéro: lead

Study Sites (1)

Clinique Du Trocadero

Paris, 75016, France

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 29, 2018
• Study Start: October 25, 2018
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: January 29, 2021

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)