Ignite Creation Date:
2024-05-06 @ 2:25 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02041507
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2014-01-18
Brief Title:
Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening
Sponsor:
Presidio Ospedaliero Santa Barbara
Organization:
Presidio Ospedaliero Santa Barbara
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Air Insufflation Water Immersion and Water Exchange for Adenoma Detection Rate in Screening Colonoscopy
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 P0001 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
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 P0001 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
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 andor polypectomy maximum pain during colonoscopy assessed during insertion and at discharge the need for sedationanalgesia 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
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 andor polypectomy maximum pain during colonoscopy assessed during insertion and at discharge the need for sedationanalgesia 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Delibera 10472013 | OTHER | ASL 07 Carbonia Italy | None |