NCT01781650

Brief Summary

Water-aided method for colonoscopy can be broadly subdivided into two major categories. Water Immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and Water Exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy. Several studies showed that WE significantly reduces pain compared to WI and colonoscopy with traditional air insufflation (AI), increases the number of unsedated procedures and adenoma detection rate (ADR), in particular proximal ADR. This randomized controlled trial will be a direct comparison of Air Insufflation, Water Immersion and Water Exchange to test the hypothesis that WAC (particularly WE) would significantly decrease pain score during colonoscopy in diagnostic patients. Several other secondary outcomes will also be analyzed.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable pain

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

January 29, 2013

Last Update Submit

January 14, 2014

Conditions

PainColorectal AdenomasColorectal Cancer

Keywords

Warm Water Infusion colonoscopyWater Immersion colonoscopyWater Exchange colonoscopyPainless unsedated colonoscopyAdenoma detection rateAdenoma resection rate

Outcome Measures

Primary Outcomes (1)

  • Maximum pain score recorded during colonoscopy.

    Pain will be assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. The patient will be informed that the request for pain information is not to remind the patient that the examination should be uncomfortable, but to let the colonoscopist be alerted to the need to use maneuvers to minimize discomfort (e.g. loop reduction, removal of colonic content, abdominal compression and/or change in patient position). At regular intervals during colonoscopy (e.g. every 2-3 minutes) patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.

    1 hour

Secondary Outcomes (8)

  • Need for sedation/analgesia and its dosage.

    1 hour

  • Overall pain after the procedure.

    1 hour.

  • Cecal intubation rate.

    1 hour

  • Cecal intubation time.

    1 hour

  • Total procedure time.

    1 hour

  • +3 more secondary outcomes

Other Outcomes (8)

  • Position changes.

    1 hour

  • Loop reduction maneuvers.

    1 hour

  • Amount of water used during the procedure.

    1 hour

  • +5 more other outcomes

Study Arms (3)

Air insufflation method.

ACTIVE COMPARATOR

Colonoscopy will be performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.

Other: Air Insufflation method.

Water Immersion method.

EXPERIMENTAL

Air will not be insufflated until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if \>3) if the lumen cannot be seen. Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal.

Other: Water Immersion method.

Water Exchange method.

EXPERIMENTAL

Air will not be insufflated until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Suction of water will also be applied when colonoscope insertion proceeds smoothly. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned.

Other: Water Exchange method.

Interventions

Air Insufflation method.OTHER

Colonoscopy will be performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.

Air insufflation method.
Water Immersion method.OTHER

Air will not be insufflated until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if \>3) if the lumen cannot be seen. Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal.

Water Immersion method.
Water Exchange method.OTHER

Air will not be insufflated until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Suction of water will also be applied when colonoscope insertion proceeds smoothly. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned.

Water Exchange method.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive 18 to 85 year-old first time diagnostic in-patients and outpatients agreeing to start procedure without premedication.

You may not qualify if:

  • patient unwillingness to start the procedure without sedation/analgesia
  • previous colorectal surgery
  • indication for a proctosigmoidoscopy or bidirectional endoscopy
  • patient refusal or inability to provide informed consent
  • inadequate bowel preparation (patients unable to swallow at least ¾ of cleansing preparation, or that did have late and insufficient evacuations, or that reported the presence of residual stools in the last evacuations).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System

Los Angeles, California, 91343, United States

Location

S. Barbara Hospital

Iglesias, CA, 09016, Italy

Location

N. S. di Bonaria Hospital

San Gavino Monreale, VS, 09037, Italy

Location

Related Publications (10)

  • Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.

    PMID: 22898423BACKGROUND

  • Brocchi E, Pezzilli R, Tomassetti P, Campana D, Morselli-Labate AM, Corinaldesi R. Warm water or oil-assisted colonoscopy: toward simpler examinations? Am J Gastroenterol. 2008 Mar;103(3):581-7. doi: 10.1111/j.1572-0241.2007.01693.x. Epub 2007 Dec 12.

    PMID: 18076732BACKGROUND

  • Rabenstein T, Radaelli F, Zolk O. Warm water infusion colonoscopy: a review and meta-analysis. Endoscopy. 2012 Oct;44(10):940-51. doi: 10.1055/s-0032-1310157. Epub 2012 Sep 17.

    PMID: 22987214BACKGROUND

  • Leung CW, Kaltenbach T, Soetikno R, Wu KK, Leung FW, Friedland S. Water immersion versus standard colonoscopy insertion technique: randomized trial shows promise for minimal sedation. Endoscopy. 2010 Jul;42(7):557-63. doi: 10.1055/s-0029-1244231. Epub 2010 Jun 30.

    PMID: 20593332BACKGROUND

  • Leung FW. Water exchange may be superior to water immersion for colonoscopy. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1012-4. doi: 10.1016/j.cgh.2011.09.007. Epub 2011 Sep 22. No abstract available.

    PMID: 21946120BACKGROUND

  • 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: 22163081BACKGROUND

  • Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.

    PMID: 20883846BACKGROUND

  • Pohl J, Messer I, Behrens A, Kaiser G, Mayer G, Ell C. Water infusion for cecal intubation increases patient tolerance, but does not improve intubation of unsedated colonoscopies. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1039-43.e1. doi: 10.1016/j.cgh.2011.06.031. Epub 2011 Jul 13.

    PMID: 21749850BACKGROUND

  • Cadoni S, Falt P, Sanna S, Argiolas M, Fanari V, Gallittu P, Liggi M, Mura D, Porcedda ML, Smajstrla V, Erriu M, Leung FW. Impact of Colonoscopy Insertion Techniques on Adenoma Detection. Dig Dis Sci. 2016 Jul;61(7):2068-75. doi: 10.1007/s10620-016-4053-1. Epub 2016 Feb 5.

    PMID: 26846118DERIVED

  • Cadoni S, Sanna S, Gallittu P, Argiolas M, Fanari V, Porcedda ML, Erriu M, Leung FW. A randomized, controlled trial comparing real-time insertion pain during colonoscopy confirmed water exchange to be superior to water immersion in enhancing patient comfort. Gastrointest Endosc. 2015 Mar;81(3):557-66. doi: 10.1016/j.gie.2014.07.029. Epub 2014 Sep 26.

    PMID: 25262100DERIVED

MeSH Terms

Conditions

PainColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Sergio Cadoni, MD

    S. Barbara Hospital, Iglesias (CA), Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Responsabile Servizio Endoscopia Digestiva

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 1, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

US(1)IT(2)