Water Exchange Versus Carbon Dioxide for Colonoscopy

NCT01633333 | Completed

• 1 other identifier: WMCO2_KG
• Study Type: interventional
• Target: 473
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Colorectal Cancer; Colorectal Adenomas; Colorectal Polyps; Pain

Keywords

Colonoscopy; Colorectal cancer; Colorectal adenomas; Pain

Outcome Measures

Primary Outcomes (1)

• Pain during colonoscopy

  Patients will be asked by a blinded assistant immediately after colonoscopy to score pain during the procedure.

  1 hour

Secondary Outcomes (6)

• Pain during colonoscopy

  30 minutes

• Cecal intubation rate

  1 hour

• Cecal intubation time

  1 hour

• Adenoma detection rate

  1 hour

• Polyp detection rate

  1 hour

Study Arms (2)

Water exchange

EXPERIMENTAL

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

Carbon dioxide insufflation

ACTIVE COMPARATOR

Carbon dioxide insufflation will be used in standard fashion to reach the cecum.

Other: Carbon dioxide insufflation

Interventions

Water exchange colonoscopy OTHER

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.

Also known as: Water exchange

Water exchange

Carbon dioxide insufflation OTHER

Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.

Also known as: Carbon dioxide

Carbon dioxide insufflation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• South-Eastern Norway Regional Health Authority: collaborator
• Maria Sklodowska-Curie National Research Institute of Oncology: collaborator
• Erasmus Medical Center: collaborator

Study Sites (3)

Sorlandet Hospital

Arendal, Norway

Location

Sorlandet Hospital

Kristiansand, N-4604, Norway

Location

The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, Poland

Location

Related Publications (19)

• 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. doi: 10.1111/j.1525-1497.2005.00164.x.

  PMID: 16307622 BACKGROUND

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

  PMID: 21527807 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2007.01387.x. Epub 2007 Jun 29.

  PMID: 17608779 BACKGROUND

• 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 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

• 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 BACKGROUND

• 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. doi: 10.4161/jig.1.3.18510. Epub 2011 Jul 1.

  PMID: 22163081 BACKGROUND

• 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. doi: 10.4161/jig.1.3.18517. Epub 2011 Jul 1.

  PMID: 22163082 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1136/gut.50.5.604.

  PMID: 11950803 BACKGROUND

• 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. doi: 10.1016/s0016-5107(02)70176-4.

  PMID: 12145595 BACKGROUND

• Church J, Delaney C. Randomized, controlled trial of carbon dioxide insufflation during colonoscopy. Dis Colon Rectum. 2003 Mar;46(3):322-6. doi: 10.1007/s10350-004-6549-6.

  PMID: 12626906 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.3748/wjg.15.5186.

  PMID: 19891018 BACKGROUND

• Riss S, Akan B, Mikola B, Rieder E, Karner-Hanusch J, Dirlea D, Mittlbock 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. doi: 10.1007/s00508-009-1202-y.

  PMID: 19657610 BACKGROUND

• 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. doi: 10.1155/2011/378906. Epub 2011 Jun 15.

  PMID: 21747649 BACKGROUND

• 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. doi: 10.4161/jig.1.2.16830.

  PMID: 21776430 BACKGROUND

• Hoff G, Bretthauer M, Huppertz-Hauss G, Kittang E, Stallemo A, Hoie 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. doi: 10.1080/00365520500265208.

  PMID: 16635918 BACKGROUND

• Garborg K, Kaminski MF, Lindenburger W, Wiig H, Hasund A, Wronska E, Bie RB, Kleist B, Lovdal L, Holme O, Kalager M, Hoff G, Bretthauer M. Water exchange versus carbon dioxide insufflation in unsedated colonoscopy: a multicenter randomized controlled trial. Endoscopy. 2015 Mar;47(3):192-9. doi: 10.1055/s-0034-1390795. Epub 2014 Nov 20.

  PMID: 25412093 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Pain

Interventions

Carbon Dioxide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Kjetil K Garborg, MD

  Sorlandet Hospital HF Kristiansand, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 4, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

PL (1); NO (2)