Water Exchange Versus Carbon Dioxide for Colonoscopy - Full Text View

Purpose

Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.

Condition	Intervention
Colorectal Cancer Colorectal Adenomas Colorectal Polyps Pain	Other: Water exchange colonoscopy Other: Carbon dioxide insufflation

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Screening
Official Title:	Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Benign Tumors Cancer Colonoscopy Colorectal Cancer Drinking Water

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:

Pain during colonoscopy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.

Secondary Outcome Measures:

Pain during colonoscopy [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Patients will be asked to report pain during colonoscpy to an unblinded study assistant.
Cecal intubation rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Cecal intubation rate is defined as successfull completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation.
Cecal intubation time [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
The time taken to complete insertion of the colonoscope.
Adenoma detection rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Detection of adenomas during each colonoscopy procedure
Polyp detection rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Detection of any colonic polyp, irrespective of histologic type, during each procedure.
Dose of medication [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
Dose of sedative and analgesic medication needed to complete the colonoscopy.

Estimated Enrollment:	500
Study Start Date:	June 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Water exchange Colonoscopy with water exchange as the sole modality to reach the cecum. Carbon dioxide can be used in case of intubation failure with the test method.	Other: Water exchange colonoscopy Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion. The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum. Other Name: Water exchange
Active Comparator: Carbon dioxide insufflation Carbon dioxide insufflation will be used in standard fashion to reach the cecum.	Other: Carbon dioxide insufflation Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure. Other Name: Carbon dioxide

Detailed Description:

Single blinded randomized controlled trial.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients scheduled for screening or polyp surveillance colonoscopy
Patients accepting sedation on demand

Exclusion Criteria:

Demand for sedation/analgesia before the start of the procedure
Previous partial or total colonic resection
Pregnancy
Unwilling/unable to provide informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633333

Contacts

Contact: Kjetil K Garborg, MD	+4738074127	kjetil.garborg@sshf.no
Contact: Michael Bretthauer, PhD	+4790132480	michael.bretthauer@medisin.uio.no

Locations

Netherlands
Erasmus Medical Center	Not yet recruiting
Rotterdam, Netherlands
Contact: Arjun D Koch, MD a.d.koch@erasmusmc.nl
Principal Investigator: Arjun D Koch, MD
Norway
Sorlandet Hospital	Completed
Arendal, Norway
Sorlandet Hospital	Completed
Kristiansand, Norway, N-4604
Poland
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Recruiting
Warsaw, Poland
Contact: Michal F Kaminski, MD mfkaminski@coi.waw.pl
Contact: Ewa Wronska, MD ewula@coi.waw.pl
Principal Investigator: Michal F Kaminski, MD
Sub-Investigator: Ewa Wronska, MD

Sponsors and Collaborators

Sorlandet Hospital HF

South-Eastern Norway Regional Health Authority

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Erasmus Medical Center

Investigators

Principal Investigator:

Kjetil K Garborg, MD

Sorlandet Hospital HF Kristiansand, Norway

More Information

Additional Information:

The NordICC trial is the framework for the Norwegian arm of the current trial. This link exits the ClinicalTrials.gov site

Publications:

Denberg TD, Melhado TV, Coombes JM, Beaty BL, Berman K, Byers TE, Marcus AC, Steiner JF, Ahnen DJ. Predictors of nonadherence to screening colonoscopy. J Gen Intern Med. 2005 Nov;20(11):989-95.

Khalid-de Bakker CA, Jonkers DM, Hameeteman W, de Ridder RJ, Masclee AA, Stockbrügger RW. Cardiopulmonary events during primary colonoscopy screening in an average risk population. Neth J Med. 2011 Apr;69(4):186-91.

Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007 Nov;102(11):2401-10. Epub 2007 Jun 29.

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. Epub 2011 May 24.

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. Epub 2011 Jul 1.

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. PubMed PMID: 21776425; PubMed Central PMCID: PMC3136853.

Leung F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with a greater reduction of pain score - review of randomized controlled trials (RCTs) of water method colonoscopy. J Interv Gastroenterol. 2011 Jul;1(3):114-120. Epub 2011 Jul 1.

Leung F, Harker J, Leung J, Siao-Salera R, Mann S, Ramirez F, Friedland S, Amato A, Radaelli F, Paggi S, Terruzzi V, Hsieh Y. Removal of infused water predominantly during insertion (water exchange) is consistently associated with an increase in adenoma detection rate - review of data in randomized controlled trials (RCTs) of water-related methods. J Interv Gastroenterol. 2011 Jul;1(3):121-126. Epub 2011 Jul 1.

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.

Bretthauer M, Thiis-Evensen E, Huppertz-Hauss G, Gisselsson L, Grotmol T, Skovlund E, Hoff G. NORCCAP (Norwegian colorectal cancer prevention): a randomised trial to assess the safety and efficacy of carbon dioxide versus air insufflation in colonoscopy. Gut. 2002 May;50(5):604-7.

Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4.

Church J, Delaney C. Randomized, controlled trial of carbon dioxide insufflation during colonoscopy. Dis Colon Rectum. 2003 Mar;46(3):322-6.

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.

Uraoka T, Kato J, Kuriyama M, Hori K, Ishikawa S, Harada K, Takemoto K, Hiraoka S, Fujita H, Horii J, Saito Y, Yamamoto K. CO(2) insufflation for potentially difficult colonoscopies: efficacy when used by less experienced colonoscopists. World J Gastroenterol. 2009 Nov 7;15(41):5186-92.

Riss S, Akan B, Mikola B, Rieder E, Karner-Hanusch J, Dirlea D, Mittlböck M, Weiser FA. CO2 insufflation during colonoscopy decreases post-interventional pain in deeply sedated patients: a randomized controlled trial. Wien Klin Wochenschr. 2009;121(13-14):464-8.

Geyer M, Guller U, Beglinger C. Carbon dioxide insufflation in routine colonoscopy is safe and more comfortable: results of a randomized controlled double-blinded trial. Diagn Ther Endosc. 2011;2011:378906. Epub 2011 Jun 15.

Leung FW, Leung JW, Mann SK, Friedland S, Ramirez FC, Olafsson S. DDW 2011 cutting edge colonoscopy techniques - state of the art lecture master class - warm water infusion/CO(2) insufflation for colonoscopy. J Interv Gastroenterol. 2011 Apr;1(2):78-82.

Hoff G, Bretthauer M, Huppertz-Hauss G, Kittang E, Stallemo A, Høie O, Dahler S, Nyhus S, Halvorsen FA, Pallenschat J, Vetvik K, Kristian Sandvei P, Friestad J, Pytte R, Coll P. The Norwegian Gastronet project: Continuous quality improvement of colonoscopy in 14 Norwegian centres. Scand J Gastroenterol. 2006 Apr;41(4):481-7.

Responsible Party:	Sorlandet Hospital HF
ClinicalTrials.gov Identifier:	NCT01633333 History of Changes
Other Study ID Numbers:	WMCO2_KG
Study First Received:	June 29, 2012
Last Updated:	May 23, 2013
Health Authority:	Norway: Regional Ethics Commitee Poland: Ethics Committee Netherlands: Institutional Review Board

Keywords provided by Sorlandet Hospital HF:

Colonoscopy
Colorectal cancer
Colorectal adenomas
Pain

Additional relevant MeSH terms:

Adenoma
Colorectal Neoplasms
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms

Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013