NCT03571061

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

Completed NA Last updated 2 January 2019

What this trial tests

NA trial testing whole colon water immersion and sigmoid water immersion in Colonoscopy in 240 participants. Completed in 26 December 2018.

Timeline

3 April 2018

Primary endpoint
26 November 2018

26 December 2018

Quick facts

Lead sponsor	Shenzhen People's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	240
Start date	3 April 2018
Primary completion	26 November 2018
Estimated completion	26 December 2018
Sites	1 location across China

Drugs / interventions tested

• whole colon water immersion and sigmoid water immersion

Conditions studied

• Colonoscopy — all drugs for Colonoscopy →

Sponsor

Shenzhen People's Hospital

Who can join

Adults 18 to 80, any sex, with Colonoscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.