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A Comparison of Air Insufflation, Water Immersion and Water Exchange Colonoscopy in CRC Screening

This study is currently recruiting participants.
Verified March 2013 by Presidio Ospedaliero Santa Barbara
Sponsor:
Information provided by (Responsible Party):
Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara
ClinicalTrials.gov Identifier:
NCT01780818
First received: January 28, 2013
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

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. These results call for a head-to head comparison of Air Insufflation, Water Immersion and Water Exchange in a randomized controlled trial, to test the hypothesis that WE may provide a strategy to improve prevention of colorectal cancer by improving ADR. The RCT would help clarify unresolved issues about water-aided colonoscopy.


Condition Intervention
Pain
Colorectal Adenomas
Colorectal Cancer
 Other: Air Insufflation method.
Other: Water Immersion method.
Other: Water Exchange method.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange During on Demand Sedation Colonoscopy in CRC Screening Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Presidio Ospedaliero Santa Barbara:

Primary Outcome Measures:
  • Maximum pain score recorded during colonoscopy. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Need for sedation/analgesia and its dosage. [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Sedation and analgesia will be available on demand. Medication will be offered when VAS score reaches ≥2 (discomfort). Patients can accept or decline the medication. If patients agree to accept the medication, it will be given. Midazolam, no more than 5 mg per patient, will be used. When pain is reported, sedation will be started with midazolam with a single intravenous dose of 2 mg, plus incremental doses of 1 mg if the patient still continues to complain about pain. To avoid bias by the colonoscopist, sedation medication will be administered based on the patients' confirmation that the pain is no longer tolerable, and not at the discretion of the colonoscopist. No other analgesic or sedative medications will be administered. The colon segment in which patients requests sedation will be recorded.

  • Overall pain after the procedure. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    After the procedure and at discharge from the Endoscopy Unit, an assistant nurse blinded to the procedure will ask patients about overall pain using the same VAS when neither the endoscopist nor the assistant nurse who performed the colonoscopy were present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.

  • Cecal intubation rate. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Cecal intubation will be defined as passage of the tip of the colonoscope beyond the ileocecal valve so that the medial wall of the cecum proximal to the ileocecal valve will be observed. 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 ]
    Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.

  • Total procedure time. [ Time Frame: 1 hour. ] [ Designated as safety issue: No ]
    Total procedure time (including time required for polyp resection or biopsy).

  • Adenoma detection rate. [ Time Frame: 10 months. ] [ Designated as safety issue: No ]
    Proportion of subjects with at least one adenoma of any size.

  • Adenoma resection rate. [ Time Frame: 10 months. ] [ Designated as safety issue: No ]
    Total number of adenomas resected per subject.

  • Advanced adenoma. [ Time Frame: 10 months. ] [ Designated as safety issue: No ]
    Total number of advanced adenomas: diameter ≥10mm, or high grade dysplasia, or with ≥20% villous components.


Other Outcome Measures:
  • Position changes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Change in patient position as needed if advancement of the colonoscope fails.

  • Loop reduction maneuvers. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Applied as needed if advancement of the colonoscope fails.

  • Amount of water used during the procedure. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Amount of infused water during insertion and withdrawal.

  • Bloating at completion of examination. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Bloating felt by patients at completion of examination on a 10 point visual analogue scale.

  • Bloating at discharge. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Bloating felt by patients at discharge measured on a ten point visual analogue scale.

  • Patients willingness to repeat the examination. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Patients willingness to repeat the examination based on overall satisfaction about procedure. Measured at discharge on a yes/no question.

  • Oxygen desaturation. [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Significant oxygen desaturation will be recorded when values less than 85% will be maintained for more than 15 seconds.

  • Vagal reaction. [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Vagal reaction is defined as heart rate <60 beats per minute accompanied by excessive sweating, nausea and/or vomiting.


Estimated Enrollment: 288
Study Start Date: March 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Air insufflation method.
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.
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.
Experimental: Water Immersion method.
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.
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.
Experimental: Water Exchange method.
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.
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.

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  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive 50 to 70 year-old first time average-risk screening patients agreeing to start procedure without premedication.

Exclusion Criteria:

  • patient unwillingness to start the procedure without sedation/analgesia
  • previous colorectal surgery
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780818

Contacts
Contact: Sergio Cadoni, MD +39 0781392 ext 2858 endodig.iglesias@gmail.com
Contact: Paolo Gallittu, MD +39 0781392 ext 2858 endodig.iglesias@gmail.com

Locations
United States, California
Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System Active, not recruiting
Los Angeles, California, United States, 91343
Italy
S. Barbara Hospital Recruiting
Iglesias, Cagliari, Italy, 09016
Contact: Sergio Cadoni, MD     +39 0781392 ext 2858     endodig.iglesias@gmail.com    
Contact: Paolo Gallittu, MD     +39 0781392 ext 2858     endodig.iglesias@gmail.com    
Principal Investigator: Sergio Cadoni, MD            
Principal Investigator: Paolo Gallittu, MD            
N. S. di Bonaria Hospital Recruiting
San Gavino Monreale, VS, Italy, 09037
Contact: Stefano Sanna, MD     +39070937 ext 8286     endo.sangav@tiscali.it    
Principal Investigator: Stefano Sanna, MD            
Sub-Investigator: Viviana Fanari, MD            
Sub-Investigator: Maria L Porcedda, MD            
Sub-Investigator: Mariangela Argiolas, MD            
Sponsors and Collaborators
Presidio Ospedaliero Santa Barbara
Investigators
Principal Investigator: Sergio Cadoni, MD S. Barbara Hospital, Iglesias (CA), Italy
  More Information

Publications:

Responsible Party: Sergio Cadoni, M.D., Responsabile Servizio Endoscopia Digestiva, Presidio Ospedaliero Santa Barbara
ClinicalTrials.gov Identifier: NCT01780818     History of Changes
Other Study ID Numbers: PG.2012.27110, ASL07_WW-2012
Study First Received: January 28, 2013
Last Updated: March 29, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Presidio Ospedaliero Santa Barbara:
Warm Water Infusion colonoscopy
Water Immersion colonoscopy
Water Exchange colonoscopy
 Painless unsedated colonoscopy
Adenoma detection rate
Adenoma resection rate

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
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

ClinicalTrials.gov processed this record on May 22, 2013