Percentage Visualized Mucosa as a Marker for the Quality of Colonoscopy

NCT04482452 | Unknown

• 1 other identifier: 2020-00074
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Primary hypothesis: The percentage of mucosa visualized during the withdrawal of a colonoscopy with reference to the position in the colon by means of the scope-guide is an appropriate parameter for assessment of the quality of colonoscopy and correlates with the probability of the detection of adenomas. Secondary hypothesis: The investigators hypothesize that the percentage of visualized mucosa differs according patient specific parameters (e.g. gender, age, BMI, bowel preparation), procedure specific parameters (e.g. patient position, device, buscopan, fentanyl, withdrawal time) and investigator specific parameters (professional experience as resident and consultant). Study Procedure/Evaluation: The endoscopic images and scope guide from colonoscopy of 500 patients will be filmed. The investigators will correlate the detection of at least one adenoma in the cohort of included patients with the percentage of visualized mucosa during the withdrawal of a colonoscopy. Additional endpoints concerning the quality of the colonoscopy will be assessed as well.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Correlation of detection of at least one adenoma with the percentage of visualized mucosa

  The investigators will correlate the detection of at least one adenoma in the cohort of included patients with the percentage of visualized mucosa during the withdrawal of a colonoscopy. In the Analysis of the investigators, the ADR will be corrected for confounders (age, gender, family history of CRC, personal history of adenomas, advanced adenomas, carcinomas, BMI and bowel preparation). Mucosa visualization will be defined as the average of the visualized mucosa over all segments of the colon.

  During the procedure

Secondary Outcomes (9)

• Correlation of the percentage of visualized mucosa (see above) with the number of polyps, number of adenomas, number of advanced adenomas

  During the procedure

• In which segment of the colon is the visualization worst

  During the procedure

• Which factors influence the visualization of the colon mucosa

  During the procedure

• Change of visualized mucosa during training of a gastroenterology resident (learning curve)

  During the procedure

• Differences in percentage visualized mucosa between individual board-certified gastroenterologists according to years of professional experience and numbers of previous endoscopies

  During the procedure

Interventions

Colonoscopy PROCEDURE

Diagnostic colonoscopy will be performed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals undergoing colonoscopy at Dept. of Visceral Surgery and Medicine, Inselspital Bern

You may qualify if:

• Signed informed consent.
• Ability to understand and follow study procedures and understand informed consent.
• Complete colonoscopy.
• Age at least 18 years.

You may not qualify if:

• \- Participation in another clinical study interfering with study procedures.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

RECRUITING

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MeSH Terms

Interventions

Colonoscopy

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 Officials

• Benjamin Misselwitz, Prof.

  Insel Gruppe AG, University Hospital Bern

  STUDY DIRECTOR

Central Study Contacts

Benjamin Misselwitz, Prof.

CONTACT

+41 31 632 5719; benjamin.misselwitz@insel.ch

Thrasyvoulos Gkrezios, MD

CONTACT

+41 31 632 5940; thrasyvoulos.gkrezios@insel.ch

Study Design

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

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 22, 2020
• Study Start: June 8, 2020
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

CH (1)