Clinical trial · Interventional
Prospective Randomized Controlled Trial Comparing Water and Air Colonoscopy in a Community Based Setting
Prospective Randomized Controlled Trial Comparing Water Exchange Colonoscopy and Air Colonoscopy in a Community Based Setting
NCT01729416CI-TRIAL-00027919completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Hyperplastic Polyp | — | UNRESOLVED | — |
| Tubular Adenoma | Tubular Adenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Air Colonoscopy | Other | — | UNRESOLVED |
| Water Exchange Colonoscopy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Water Exchange Colonoscopy
- description
- The intervention will be water exchange colonoscopy in patients who are randomized to have screening colonoscopy with water exchange colonoscopy.
- interventionNames
- Other: Water Exchange Colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Air colonoscopy
- description
- The intervention will be colonoscopy using the traditional air method in patients who are randomized to have screening colonoscopy with air colonoscopy.
- interventionNames
- Other: Air Colonoscopy
Primary outcomes (1)
- measure
- Proximal Adenoma detection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (9)
- BACKGROUNDZauber 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
- BACKGROUNDRex 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
- BACKGROUNDLeung 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
- BACKGROUNDLeung 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
- BACKGROUNDLeung 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
- BACKGROUNDLeung 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