Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Presidio Ospedaliero Santa Barbara
Sponsor:
Information provided by (Responsible Party):
Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara
ClinicalTrials.gov Identifier:
NCT02041507
First received: January 18, 2014
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer.

Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm, P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy.

Water-aided colonoscopy (WAC) can be subdivided broadly 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.

In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the proximal colon.

In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy.

We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for further testing that WE may provide a strategy to improve prevention of colorectal cancer by increasing detection of adenomas in screening colonoscopy.

Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases of colonoscopy will be done by different investigators. The second investigator will be blinded to the method used to insert the instrument, thus eliminating possible bias about procedure related issues.

Several secondary outcomes will also be analysed.


Condition Intervention
Colorectal Cancer
Colorectal Adenomas
Colorectal Polyps
Pain
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: Double Blind (Subject, Investigator)
Official Title: A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange for Adenoma Detection Rate in Screening Colonoscopy

Resource links provided by NLM:


Further study details as provided by Presidio Ospedaliero Santa Barbara:

Primary Outcome Measures:
  • Adenoma Detection Rate. [ Time Frame: 18 months. ] [ Designated as safety issue: No ]
    Proportion of subjects with at least one adenoma of any size.


Secondary Outcome Measures:
  • Proximal colon Adenoma Detection Rate. [ Time Frame: 18 months. ] [ Designated as safety issue: No ]
    Proportion of subjects with at least one adenoma of any size in the proximal colon.

  • Proximal colon <10 mm Adenoma Detection Rate. [ Time Frame: 18 months. ] [ Designated as safety issue: No ]
    Proportion of subjects with at least one adenoma <10 mm in the proximal colon.

  • Mean adenomas resected per procedure. [ Time Frame: 18 months. ] [ Designated as safety issue: No ]
    Total number of adenomas resected per subject.

  • 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.

  • 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).

  • Maximum pain score recorded during insertion phase of colonoscopy. [ Time Frame: 1 hour. ] [ Designated as safety issue: No ]
    Pain will be measured on a visual analogue scale (VAS) with a score 0=absence of pain, 1-2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patient. Patient will be informed that the request for pain information is not to remind 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 60 seconds) patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.

  • Pain score at discharge. [ 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 maximum pain during insertion phase of the procedure using the same VAS when neither the endoscopist nor the assistant nurse who performed the colonoscopy will be present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.

  • Need for sedation/analgesia and its dosage [ Time Frame: 1 hour. ] [ Designated as safety issue: Yes ]
    All patients will be offered sedation for the procedure. Patients can accept or decline the medication. If they accept, the procedure will be started with the administration of 2 mg of Midazolam intravenously (minimal sedation). If the patient will choose on-demand sedation, minimal sedation will be offered when pain score reaches ≥2 on the VAS. Patients can accept or decline the offered medication. If they accept, minimal sedation will be administered as described above. 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. The colon segment in which patients requests sedation will be recorded. If additional medication will be required despite the abovementioned maneuvers and/or minimal sedation, it will be provided according to local standards and it will be recorded.


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

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

  • Abdominal compression. [ Time Frame: 1 hour. ] [ Designated as safety issue: No ]
    Compression of abdomen if advancement of the colonoscope fails.

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

  • 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.


Estimated Enrollment: 1200
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Air insufflation method.
Colonoscopy 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.
Air insufflation colonoscopy.
Experimental: Water Immersion method.
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. Insufflation not used 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. Withdrawal phase done using air insufflation.
Other: Water Immersion method.
Water Immersion during insertion, air insufflation during withdrawal.
Experimental: Water Exchange method.
Insufflation not used 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. 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. Withdrawal phase done using air insufflation.
Other: Water Exchange method.
Water Exchange during insertion, air insufflation during withdrawal.

Detailed Description:

Design: Prospective double-blinded multicenter randomized controlled trial. Methods: Colonoscopy with Air Insufflation, Water Immersion, Water Exchange to aid insertion of colonoscope; split dose bowel preparation. Sedation available at the start of the procedure or on-demand.

Control method: Air insufflation colonoscopy. Study methods: Water Immersion colonoscopy, Water Exchange colonoscopy.

Population: Consecutive 50 to 70 year-old screening patients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.

Primary outcome: overall Adenoma Detection Rate. Secondary outcomes: proximal colon ADR, Mean Adenomas resected per Procedure (MAP), cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), maximum pain during colonoscopy assessed during insertion and at discharge, the need for sedation/analgesia and its dosage. In addition loop reduction maneuvers, position changes, abdominal compression, the amount of infused and suctioned water during insertion and withdrawal, and patients willingness to repeat the examination will be evaluated.

  Eligibility

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

Inclusion Criteria:

  • consecutive screening patients

Exclusion Criteria:

  • previous colonoscopy within 5 years
  • surveillance colonoscopy
  • previous colorectal surgery
  • indication for a proctosigmoidoscopy or bidirectional endoscopy
  • history of inflammatory bowel disease
  • patient refusal or inability to provide informed consent
  • inadequate consumption of bowel preparation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041507

Contacts
Contact: Sergio Cadoni, MD 00390781392 ext 2858 cadonisergio@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
Czech Republic
Digestive Diseases Center, Vìtkovice Hospital Recruiting
Ostrava, Czech Republic, 703 84
Contact: Přemysl Falt, MD    0042060268 ext 9561    faltprem@centrum.cz   
Principal Investigator: Přemysl Falt, MD         
Italy
Digestive Endoscopy Unit, Ospedale S. Barbara Recruiting
Iglesias, CI, Italy, 09016
Contact: Sergio Cadoni, MD    00390781392 ext 2858    cadonisergio@gmail.com   
Principal Investigator: Sergio Cadoni, MD         
Division of Gastroenterology, Ospedale Valduce Recruiting
Como, CO, Italy, 22100
Contact: Franco Radaelli, MD    003903130 ext 0940    francoradaelli@virgilio.it   
Principal Investigator: Franco Radaelli, MD         
Digestive Endoscopy and Gastroenterology Unit, Nuovo Ospedale Civile S.Agostino-Estense Not yet recruiting
Baggiovara di Modena, MO, Italy, 41126
Contact: Mauro Manno, MD    0039059396 ext 2215    mauromanno@gmail.com   
Principal Investigator: Mauro Manno, MD         
Sponsors and Collaborators
Presidio Ospedaliero Santa Barbara
Investigators
Principal Investigator: Sergio Cadoni, MD S. Barbara Hospital, Iglesias (CI), Italy
  More Information

Publications:
Responsible Party: Sergio Cadoni, M.D., Responsabile Servizio Endoscopia Digestiva, Presidio Ospedaliero Santa Barbara
ClinicalTrials.gov Identifier: NCT02041507     History of Changes
Other Study ID Numbers: PI.2013.2502, Delibera 1047.2013
Study First Received: January 18, 2014
Last Updated: August 2, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Presidio Ospedaliero Santa Barbara:
Water-aided colonoscopy
Water Immersion
Water Exchange
On-demand sedation
Unsedated colonoscopy
Adenoma detection rate
Mean adenomas per procedure

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 September 16, 2014