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Completed

NCT Number: NCT03344055

Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. 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 as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique PARIS-BERCY

Charenton-le-Pont, 94220, France

About this study

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. 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 as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

Number of patients:

2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).

Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).

Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.

The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.

A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Opposition expressed for inclusion in the study

Treatment and study plan

Endocuff Vision (ECV) second generation

Device

Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope

Primary outcomes

  1. Adenoma detection rate (ADR)

    Time frame: during procedure

    rate (%) of colonoscopies with one or more adenoma detected

Secondary outcomes

  1. Polyp detection rate (PDR)

    Time frame: during procedure

    rate (%) of colonoscopies with one or more polyp detected

  2. Advanced neoplasia detection rate (ANDR)

    Time frame: during procedure

    rate (%) of colonoscopies with one or more advanced neoplasia detected

  3. Serrated polyp detection rate (SPDR)

    Time frame: during procedure

    rate (%) of colonoscopies with one or more serrated polyp detected

  4. Morbidity: perforation rate (%)

    Time frame: 21 days after procedure

    Perforation rates (%)

  5. Morbidity: bleeding rate (%)

    Time frame: 21 days after procedure

    Bleeding rates (%)

  6. caecal intubation rate (%)

    Time frame: during procedure

    caecal intubation rate (complete colonoscopy)

  7. Time to reach caecum (sec)

    Time frame: during procedure

    Time to reach caecum from the beginning of the procedure (in seconds)

  8. withdrawal time (sec)

    Time frame: during procedure

    withdrawal time of the scope from the caecum to the end of the procedure (in seconds)

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice

Acronym: Cuff-Bercy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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