Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy
- Conditions
- Adenoma Colon
- Interventions
- Other: Water exchange colonoscopyOther: acetic acid staining
- Registration Number
- NCT04464135
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve the detection of flat lesions compared with WE alone.
- Detailed Description
Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017 04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group, water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least 6 min. The observation was initially performed without the assistance of cap or the use of magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide or glucogon was not routinely administrated.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Aged 40-70
- Undergoing colonoscopy after standard bowel preparation
- Known familial polyposis
- Small amount of feces or semi-solid stool in last rectal effluent
- Inflammatory Bowel Disease
- Lactated or pregnant women
- Unable to provide informed content
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WE group Water exchange colonoscopy Water exchange colonoscopy was used for standard screening or surveillance colonoscopy. WE+AA group acetic acid staining Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.
- Primary Outcome Measures
Name Time Method Number of flat polyps per patient 9 months average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
- Secondary Outcome Measures
Name Time Method Adverse events 9 months the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.
Overall ADR 9 months Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.
Advanced ADR 9 months Advanced adenoma detection rate. 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.
SSA/P detection rate 9 months SSA/P detection rate, defined as the proportion of subjects with at least one sessile serrated adenoma/polyp (SSA/P) of any size, in each group.
Flat neoplasms located in proximal colon 9 months Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon
Trial Locations
- Locations (4)
Department of Gastroenterology, Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
Department of Gastroenterology, Shaanxi Second People's Hospital
🇨🇳Xi'an, Shaanxi, China
Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University
🇨🇳Lanzhou, Gansu, China
Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
🇨🇳Shenzhen, Guangdong, China