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

Pain Clinical Trial

Official title:

A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange for Adenoma Detection Rate in Screening Colonoscopy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02041507
• Other study ID #: PI.2013.2502
• Secondary ID: Delibera 1047.20
• Status: Active, not recruiting
• Phase: N/A
• First received: January 18, 2014
• Last updated: March 21, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2016
• Source: Presidio Ospedaliero Santa Barbara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1224
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenomas
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyps
• Pain

Intervention

Other:
• Air insufflation method.
Air insufflation colonoscopy.
• Water Immersion method.
Water Immersion during insertion, air insufflation during withdrawal.
• Water Exchange method.
Water Exchange during insertion, air insufflation during withdrawal.

Locations

Country	Name	City	State
Czech Republic	Digestive Diseases Center, Vìtkovice Hospital	Ostrava
Italy	Division of Gastroenterology, Ospedale Valduce	Como	CO
Italy	Digestive Endoscopy Unit, Ospedale S. Barbara	Iglesias	CI
United States	Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Presidio Ospedaliero Santa Barbara

Countries where clinical trial is conducted

United States,  Czech Republic,  Italy, 

References & Publications (6)

Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11. — View Citation

Gupta S, Balasubramanian BA, Fu T, Genta RM, Rockey DC, Lash R. Polyps with advanced neoplasia are smaller in the right than in the left colon: implications for colorectal cancer screening. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1395-1401.e2. doi: 10.1016/j.cgh.2012.07.004. Epub 2012 Jul 24. — View Citation

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. Review. — View Citation

Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loop reduction maneuvers.	Applied as needed if advancement of the colonoscope fails.	1 hour.	No
Other	Position changes. Position changes. Position changes. Position changes. Position changes.	Change in patient position as needed if advancement of the colonoscope fails.	1 hour.	No
Other	Abdominal compression.	Compression of abdomen if advancement of the colonoscope fails.	1 hour.	No
Other	Amount of water used during the procedure.	Amount of water infused and aspirated during insertion and withdrawal.	1 hour.	No
Other	Patients willingness to repeat the examination.	Patients willingness to repeat the examination based on overall satisfaction about procedure. Measured at discharge on a yes/no question.	1 hour.	No
Primary	Adenoma Detection Rate.	Proportion of subjects with at least one adenoma of any size.	18 months.	No
Secondary	Proximal colon Adenoma Detection Rate.	Proportion of subjects with at least one adenoma of any size in the proximal colon.	18 months.	No
Secondary	Proximal colon <10 mm Adenoma Detection Rate.	Proportion of subjects with at least one adenoma <10 mm in the proximal colon.	18 months.	No
Secondary	Mean adenomas resected per procedure.	Total number of adenomas resected per subject.	18 months.	No
Secondary	Cecal intubation rate.	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.	1 hour.	No
Secondary	Cecal intubation time.	Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.	1 hour.	No
Secondary	Total procedure time.	Total procedure time (including time required for polyp resection or biopsy).	1 hour.	No
Secondary	Maximum pain score recorded during insertion phase of colonoscopy.	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.	1 hour.	No
Secondary	Pain score at discharge.	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.	1 hour.	No
Secondary	Need for sedation/analgesia and its dosage	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.	1 hour.	Yes