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Comparisons of SWI, WWI and CI in Potentially Difficult Colonoscopy.

NCT03571061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-01-02

No results posted yet for this study

Summary

Colonoscopy insertion is technically challenging, time-consuming, and painful, especially for the sigmoid. It is reported that the difficult colonoscopy score (DCS) \>1 can predict the difficulty during colonoscopy. Patients with DCS\>1 had longer insertion time, higher pain score and needed more abdominal compression and position changes. As reported, water-aided method colonoscopy examination is an important and useful method because it reduces discomfort and increases cecal intubation rate compared with usual air insufflation method. But a longer time was consumed for scope insertion and cecal intubation in the traditional water-aided method colonscopy(the whole water immersion). To avoid these disadvantages ,we modified whole colon water immersion(WWI) method to the sigmoid colon water immersion(SWI), where the most difficult and painful part of colonoscopy resides. If water immersion is limited to the sigmoid colon in such patients, would it be more efficient and less time consuming?

The aim of this study was to investigate the application of water-aided method on cecal intubation time in potentially difficult colonoscopy. This prospective, randomized controlled study allocated patients who's difficult colonoscopy score(DCS) \>1 (18-80 years) to sigmoid-colon water immersion(SWI), whole colon water immersion(WWI) or carbon dioxide (CO2) insufflation (CI) group (1:1:1). The primary outcome was cecal intubation time. The secondary outcomes included the maximum pain score (0=none,10=most severe) during the insertion phase in left, transverse and right colon; cecal intubation rate; adenoma detection rate(ADR); bowel preparation quality; withdrawal time(from cecum to rectum excluding time for biopsy and polypectomy); willingness to undergo a repeat unsedated colonoscopy; number of abdominal compressions, position change during the insertion. Patients were educated to understand the meaning of visual analogue scale (VAS) (0 = no pain, 10 = most severe) and to report their maximum pain scores during the insertion through each colonic segment. Descriptive statistics were used to summarize demographic and baseline data. Analyses were performed with SPSS software version 24.0 for Windows (SPSS Inc, IBM Company).

Conditions

  • Colonoscopy

Interventions

PROCEDURE

whole colon water immersion and sigmoid water immersion

we chose water immersion method instead of the triaditional method of carbon dioxide (CO2) insufflation.

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2018-11-26
Completion
2018-12-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03571061 on ClinicalTrials.gov