Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting

NCT01729416 | Completed

• 2 other identifiers: 297959297959-4
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if screening colonoscopy performed on adults with the water exchange method, as opposed to the air method, will have a higher adenoma detection rate.

Conditions

Tubular Adenoma; Colon Cancer; Hyperplastic Polyp

Keywords

colon; cancer; screening; water exchange; air; method; polyp; adenoma; detection; rate; sedation; time; procedure

Outcome Measures

Primary Outcomes (1)

• Proximal Adenoma detection

  Presence of adenoma detected anywhere between the cecum and the splenic flexure

  Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is collected only once per patient.

Secondary Outcomes (21)

• Total adenoma detection

  Data collected when pathology is available, typically 3-10 days after the patient's procedure. Data is only collected once per patient.

• Sedation requirements

  This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.

• Total procedure time

  This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.

• Cecal intubation time

  This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.

• Patient position change during procedure

  This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.

Study Arms (2)

Water Exchange Colonoscopy

EXPERIMENTAL

The intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy.

Other: Water Exchange Colonoscopy

Air colonoscopy

ACTIVE COMPARATOR

The intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy.

Other: Air Colonoscopy

Interventions

Water Exchange Colonoscopy OTHER

We will turn off the air pump. The colonoscope will be inserted into the rectum and gently advanced. We will suction air pockets as scope is advanced towards the cecum. Water will be infused when encountering closed up lumen. All the infused water will be suctioned out. We will use all other techniques used with conventional air method as needed. For example abdominal pressure, shortening of scope to reduce looping, change of patient position etc. We will turn on air pump once cecum reached, or if unsuccessful with water method to open up a close lumen or to go past a tight turn. On withdrawal we will continue air insufflation as needed, and closely examine for polyps and remove all visualized polyps. If there is any residual fluid, it will be suctioned out as the scope is withdrawn.

Water Exchange Colonoscopy

Air Colonoscopy OTHER

Air will be infused into the colon during colonoscopy.

Air colonoscopy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥50 years
• Individuals able to provide informed consent
• Individuals presenting for average-risk colorectal cancer screening by colonoscopy
• Individuals presenting for surveillance of adenomatous/sessile serrated colon polyps as per the US multi-society taskforce on colorectal cancer

You may not qualify if:

• Patients who decline to participate
• Prior partial or complete colectomy
• Patients with history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
• Patients with prior history of colorectal cancer
• Patients with history of screening colonoscopy within the past 10 years
• Patients with history of familial polyposis syndromes (Familial Adenomatous Polyposis, Lynch Syndrome)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Elk Grove PCN, University of California, Davis

Elk Grove, California, 95758, United States

Location

Related Publications (9)

• Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.

  PMID: 22356322 BACKGROUND

• Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.

  PMID: 8978338 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.

  PMID: 21184876 BACKGROUND

• 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 BACKGROUND

• Ramirez FC, Leung FW. A head-to-head comparison of the water vs. air method in patients undergoing screening colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):130-135. doi: 10.4161/jig.1.3.18512. Epub 2011 Jul 1.

  PMID: 22163084 BACKGROUND

• Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

  PMID: 19136102 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasms; Polyps; Adenoma

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Sooraj Tejaswi, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 20, 2012
• Study Start: February 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

US (1)