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Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy

Effect of Water Exchange Method on Adenoma Miss Rates in Patients Undergoing Selective Polypectomy: a Single-centered, Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02880748
Enrollment
450
Registered
2016-08-26
Start date
2016-08-31
Completion date
2017-08-31
Last updated
2016-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma

Keywords

Water exchange colonoscopy, Adenoma miss rate, Polyps

Brief summary

Patients with colorectal adenomas are suggested to receive polypectomy. A substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. And water exchange (WE) method may increase the detection of missed adenoma compared with traditional air insufflation (AI) colonoscopy. The investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.

Detailed description

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).

Interventions

OTHERWater 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.

OTHERAir 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.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-80 patients undergoing selective polypectomy

Exclusion criteria

* Polyps found more than 6 months * Patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer * Patients with history of inflammatory bowel disease * Patients with planning to undergo Endoscopic Submucosal Dissection(ESD) * Patients not undergoing standard bowel preparation * Patients with solid feces in the last stool after bowel preparation * Patients considered to be high risk for bleeding during Endoscopic mucosal resection (EMR), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy * Hemodynamically unstable * Pregnant women * Unable to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Adenoma miss rate12 monthsAdenoma 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.

Secondary

MeasureTime frameDescription
Advanced adenoma miss rate/Miss advanced adenoma per colonoscopy12 monthsAdvanced 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)12 monthsThe mean number of adenoma per positive patient
adenoma-level miss rate12 monthsAdenoma-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.
Complication rate12 monthsBleeding, perforation and others
Pain Scores on the Visual Analog Scale compared with previous colonoscopy12 months0 = no pain, to 10 = most severe pain
Quality of Bowel Preparation12 monthsThe 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.

Countries

China

Contacts

Primary ContactGui Ren, MD
renguigz@hotmail.com+86298477136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026