Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy
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|ClinicalTrials.gov Identifier: NCT02880748|
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adenoma||Other: Water exchange (WE) method Other: Air insufflation (AI) method.||Not Applicable|
For WE method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. Residual air in the lumen was suctioned to minimize angulations at flexures. Water at 37°C was infused with a pump (Olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. The infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. Occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. If the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the WE method would be continuously used until successful intubation.
For the AI method, water was not used, and air was insufflated during insertion.
Air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. Polyps will be removed by forceps biopsy (polyps size <3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
Experimental: Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum.
Other: Water exchange (WE) method
Water exchange (WE) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
Active Comparator: Air insufflation (AI) method
Air insufflation (AI) method was used for insertion to the cecum.
Other: Air insufflation (AI) method.
Air insufflation (AI) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
- Adenoma miss rate [ Time Frame: 12 months ]Adenoma miss rate was calculated as the number of patients with one and more additional adenomas during polypectomy procedure divided by the total number of patients in each group.
- adenoma-level miss rate [ Time Frame: 12 months ]Adenoma-level miss rate was calculated as the number of additional adenomas detected in polypectomy procedure divided by the total number of adenomas in each group.
- Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy [ Time Frame: 12 months ]Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
- Adenoma per positive patient (APP) [ Time Frame: 12 months ]The mean number of adenoma per positive patient
- Quality of Bowel Preparation [ Time Frame: 12 months ]The Boston Bowel Preparation Scale (BBPS): cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
- Complication rate [ Time Frame: 12 months ]Bleeding, perforation and others
- Pain Scores on the Visual Analog Scale compared with previous colonoscopy [ Time Frame: 12 months ]0 = no pain, to 10 = most severe pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880748
|Contact: Gui Ren, MDfirstname.lastname@example.org|
|Endoscopic center, Xijing Hospital of Digestive Diseases||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Gui Ren, MD +862984771536 email@example.com|
|Principal Investigator: Gui Ren, MD|
|Principal Investigator:||Yanglin Pan, MD||Xijing Hospital of Digestive Diseases|