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Colorectal CancerNCT01633333

Water Exchange Versus Carbon Dioxide for Colonoscopy

A study testing Water exchange colonoscopy and Carbon dioxide insufflation in people with Colorectal Cancer and Colorectal Adenomas, run by Sorlandet Hospital HF at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
What is being tested?
Water exchange colonoscopy and Carbon dioxide insufflation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
473 participants
Where
3 sitesin 2 countries
Study dates
Jun 2012to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Norway2 sites

  • Sorlandet Hospital

    Arendal

  • Sorlandet Hospital

    Kristiansand, N-4604

Other trials in Norway

Poland1 site

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

    Warsaw

Other trials in Poland

About this study

Official title: Water Exchange Versus Carbon Dioxide Insufflation to Improve Colonoscopy Screening - a Randomized Controlled Trial

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.

Read the detailed description

Single blinded randomized controlled trial.

Being tested
Water exchange colonoscopy, Carbon dioxide insufflation
Keywords
Colonoscopy, Colorectal cancer, Colorectal adenomas, Pain
Medical subject headings
Colorectal Neoplasms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Water exchange colonoscopyOther

    Also called Water exchange

    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.

  • Carbon dioxide insufflationOther

    Also called Carbon dioxide

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

Study groups in NCT01633333
Study groupRoleWhat they receive
Water exchangeExperimentalColonoscopy 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.
Receives: Other: Water exchange colonoscopy
Carbon dioxide insufflationActive comparatorCarbon dioxide insufflation will be used in standard fashion to reach the cecum.
Receives: Other: Carbon dioxide insufflation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain during colonoscopy

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

    Measured: 1 hour

Secondary outcomes (6)

  1. Pain during colonoscopy

    Patients will be asked to report pain during colonoscopy to an unblinded study assistant.

    Measured: 30 minutes

  2. Cecal intubation rate

    Cecal intubation rate is defined as successful completion of colonoscopy insertion. This will be analyzed on an intention-to-treat basis according to group allocation.

    Measured: 1 hour

  3. Cecal intubation time

    The time taken to complete insertion of the colonoscope.

    Measured: 1 hour

  4. Adenoma detection rate

    Detection of adenomas during each colonoscopy procedure

    Measured: 1 hour

  5. Polyp detection rate

    Detection of any colonic polyp, irrespective of histologic type, during each procedure.

    Measured: 1 hour

  6. Dose of medication

    Dose of sedative and analgesic medication needed to complete the colonoscopy.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633333
Sponsor's protocol ID
WMCO2_KG
Status last verified
Feb 2014
First submitted
29 Jun 2012
Last updated
12 Feb 2014
Results posted
No
Data monitoring committee
No

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

    PubMed 16307622

  • 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.

    PubMed 21527807

  • 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.

    PubMed 17608779

  • 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.

    PubMed 21611947

  • 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.

    PubMed 22163084

  • 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.

    PubMed 21776425

  • 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.

    PubMed 22163081

  • 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.

    PubMed 22163082

  • 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.

    PubMed 1397911

  • 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.

    PubMed 11950803

  • 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.

    PubMed 12145595

  • 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.

    PubMed 12626906

  • 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.

    PubMed 18959640

  • 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.

    PubMed 19891018

  • 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.

    PubMed 19657610

Questions about this trial

What is this clinical trial studying?

A study testing Water exchange colonoscopy and Carbon dioxide insufflation in people with Colorectal Cancer and Colorectal Adenomas, run by Sorlandet Hospital HF at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain during colonoscopy (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01633333, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014; AzTrials last refreshed its copy on 31 Oct 2026.

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