Comparison of Adenoma Detection Rate Among Water, Carbon Dioxide and Air Methods of Minimal Sedation Colonoscopy

NCT01782014 | Terminated Phase 3 DMC

• 2 other identifiers: 5130003LLUMCGI2013
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine which of the methods of colonoscopy viz. water insufflation or air insufflation or carbon dioxide insufflation is better in detecting the adenomas in colon and also which of these methods is best tolerated by patients. Hypothesis: the investigators hypothesize that in patients undergoing first time screening colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group randomized to the water method compared to those randomized to the air or CO2 insufflation methods

Conditions

Screening Colonoscopy

Keywords

Screening colonoscopy; Water method; Carbon dioxide method; Air method; Water versus carbon dioxide versus air insufflation colonoscopy; Adenoma Detection Rate; Pain Scores in colonoscopy

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate, proximal colon and total

  The number of adenomas detected in proximal colon and total number of adenomas detected during the procedure will be compared between the three methods

  Day 1, At time of colonoscopy

Secondary Outcomes (2)

• Pain scores

  during and immediately after colonoscopy on day 1

• Sedation requirements

  Collected at Day 1, during the procedure

Other Outcomes (1)

• Patient overall satisfaction score

  immediately after colonoscopy on day 1

Study Arms (3)

Water Insufflation

EXPERIMENTAL

Colonoscopy using water insufflation

Procedure: colonoscopy

Carbon dioxide insufflation

ACTIVE COMPARATOR

Colonoscopy using carbon dioxide insufflation

Procedure: colonoscopy

Air insufflation

ACTIVE COMPARATOR

Colonoscopy using air insufflation

Procedure: colonoscopy

Interventions

colonoscopy PROCEDURE

colonoscopy using different methods of insufflation

Air insufflation; Carbon dioxide insufflation; Water Insufflation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic patients with average risk for colorectal cancer, who are scheduled for first-time screening colonoscopy, will be enrolled.

You may not qualify if:

• decline to be randomized
• unable to give consent
• non-screening (surveillance or diagnostic) colonoscopy
• current participation in other colonoscopy studies
• a medical condition that could increase the risk associated with colonoscopy
• pregnancy
• those with a known family history of polyposis syndromes or a family history of colon cancer

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (9)

• Leung FW, Aharonian HS, Leung JW, Guth PH, Jackson G. Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):546-50. doi: 10.1016/j.gie.2008.08.014.

  PMID: 19231497 RESULT

• Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.

  PMID: 19555938 RESULT

• Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.

  PMID: 20619405 RESULT

• Leung JW, Do LD, Siao-Salera RM, Ngo C, Parikh DA, Mann SK, Leung FW. Retrospective analysis showing the water method increased adenoma detection rate - a hypothesis generating observation. J Interv Gastroenterol. 2011 Jan;1(1):3-7. doi: 10.4161/jig.1.1.14585.

  PMID: 21686105 RESULT

• Leung FW, Leung JW, Siao-Salera RM, Mann SK. The water method significantly enhances proximal diminutive adenoma detection rate in unsedated patients. J Interv Gastroenterol. 2011 Jan;1(1):8-13. doi: 10.4161/jig.1.1.14587.

  PMID: 21686106 RESULT

• Leung FW, Leung JW, Siao-Salera RM, Mann SK, Jackson G. The water method significantly enhances detection of diminutive lesions (adenoma and hyperplastic polyp combined) in the proximal colon in screening colonoscopy - data derived from two RCT in US veterans. J Interv Gastroenterol. 2011 Apr;1(2):48-52. doi: 10.4161/jig.1.2.16826.

  PMID: 21776425 RESULT

• Stevenson GW, Wilson JA, Wilkinson J, Norman G, Goodacre RL. Pain following colonoscopy: elimination with carbon dioxide. Gastrointest Endosc. 1992 Sep-Oct;38(5):564-7. doi: 10.1016/s0016-5107(92)70517-3.

  PMID: 1397911 RESULT

• Wong JC, Yau KK, Cheung HY, Wong DC, Chung CC, Li MK. Towards painless colonoscopy: a randomized controlled trial on carbon dioxide-insufflating colonoscopy. ANZ J Surg. 2008 Oct;78(10):871-4. doi: 10.1111/j.1445-2197.2008.04683.x.

  PMID: 18959640 RESULT

• Leung FW, Leung JW, Mann SK, Friedland S, Ramirez FC. The water method significantly enhances patient-centered outcomes in sedated and unsedated colonoscopy. Endoscopy. 2011 Sep;43(9):816-21. doi: 10.1055/s-0030-1256407. Epub 2011 May 24.

  PMID: 21611947 RESULT

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

• Kendrick Che, DO

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

• Terrence Lewis, MD

  Loma Linda University Medical Center

  STUDY CHAIR

• Michael Walter, MD

  Loma Linda University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2013
• First Posted: February 1, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2014-09

Locations

US (1)