The Impact of Warmed Carbon Dioxide Insufflation During Colonoscopy on Polyp Detection

NCT02065037 | Terminated DMC

• 2 other identifiers: 6011440DMED-1658-13
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the second most common cancer in the world and the second leading cause of cancer-related mortality. Colorectal cancers arise from precursor adenomatous polyps in a well characterized adenoma to carcinoma progression. The removal of such precursor lesions reduces colorectal cancer mortality between 30 to 50%. Colonoscopy is used for detection of neoplastic polyps but significant miss rates of such lesions are reported. Methods to reduce spasm of the colon have been investigated to increase adenoma detection rates including the use of warm water irrigation and hyoscine butyl bromide. Carbon dioxide warmed to body temperature is postulated to have spasmolytic effects. Administration of warmed carbon dioxide during colonoscopy may improve polyp detection. Objective: In this study, colonoscopy using warmed carbon dioxide insufflation will be compared to standard room temperature air insufflation to see if there is a greater detection of polyps per patient. Methods: Patients undergoing colonoscopy for screening and surveillance indications will be included and randomized to receive either room temperature room air or warmed carbon dioxide (37 degrees Celsius). Endoscopists and patients will be blinded to the intervention. Data on indication, preparation, sedation, withdrawal time will be recorded. Polyp detection rate will be the primary outcome. Secondary outcomes will include adenoma detection rate and advanced lesion detection rates.

Conditions

Colonic Polyps; Colonic Neoplasms

Keywords

Insufflation; Carbon Dioxide; Colonic Polyps; Colonoscopy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Polyp Detection Rate

  time of endoscopy

Secondary Outcomes (2)

• adenoma detection rate

  2 weeks

• advanced lesion per patient detection rate

  2 weeks

Other Outcomes (5)

• cecal intubation rate

  day of colonoscopy

• withdrawal time

  day of colonoscopy

• anesthetic doses

  day of colonoscopy

Study Arms (2)

Warmed Carbon Dioxide Insufflation

EXPERIMENTAL

warmed carbon dioxide insufflation used in colonoscopy

Device: warmed carbon dioxide insufflation

Room Temperature Air Insufflation

ACTIVE COMPARATOR

room temperature air insufflation used in colonoscopy

Device: room temperature air insufflation

Interventions

room temperature air insufflation DEVICE

control arm

Room Temperature Air Insufflation

warmed carbon dioxide insufflation DEVICE

comparator arm

Warmed Carbon Dioxide Insufflation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatients undergoing routine screening or surveillance colonoscopy for colorectal cancer and / or polyp surveillance at Hotel Dieu Hospital

You may not qualify if:

• patients who have undergone colonic resections
• active inflammatory bowel disease
• hereditary polyposis syndromes
• moderate to severe chronic obstructive pulmonary disease
• obstructive sleep apnea requiring continuous positive airway pressure or biphasic positive airway pressure
• neurologic diagnoses affecting ventilation

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L5G2, Canada

Location

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Lawrence Hookey, MD

  Queens University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Director of Endoscopy

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 17, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 16, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)