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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03571061
Recruitment Status : Not yet recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Information provided by (Responsible Party):
Shenzhen People's Hospital

Brief 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 air insufflation (AI) 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; polyp detection rate(PDR); 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 19.0 for Windows (SPSS Inc, IBM Company).

Condition or disease Intervention/treatment Phase
Colonoscopy Procedure: whole colon water immersion and sigmoid water immersion Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Comparisons of Sigmoid-colon Water Immersion, the Whole Colon Water Immersion and Air Insufflation on Cecal Intubation Time in Potentially Difficult Colonoscopy by Difficult Colonoscopy Score(DCS) >1.
Estimated Study Start Date : July 3, 2018
Estimated Primary Completion Date : October 3, 2018
Estimated Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: whole colon water immersion group
whole colon water immersion group: the air supply was turn off until the cecum was reached. For adequate lumen distention to advance the colonoscope tip, warm water which stored in 1L bottles and maintained 37°C with a water bath, was instilled intermittently into the colon through the auxiliary working channel of colonoscope using a footswitch-controlled flushing pump
Procedure: whole colon water immersion and sigmoid water immersion
we chose water immersion method instead of the triaditional method of air insufflation.
Other Name: air insufflation

Experimental: sigmoid water immersion group
sigmoid water immersion group: air pump would be turned off and the procedure would be switched from water immersion method to air insufflation method after successful passage through the descending sigmoid junction.
Procedure: whole colon water immersion and sigmoid water immersion
we chose water immersion method instead of the triaditional method of air insufflation.
Other Name: air insufflation

Placebo Comparator: air insufflation
air insufflation group: air was insufflated through out the whole procedure for advancement and inspection when needed.
Procedure: whole colon water immersion and sigmoid water immersion
we chose water immersion method instead of the triaditional method of air insufflation.
Other Name: air insufflation

Primary Outcome Measures :
  1. cecal intubation time [ Time Frame: 3 months ]
    the time the colonoscope advanced from the anus to the cecum

Secondary Outcome Measures :
  1. maximum pain score [ Time Frame: 3 months ]
    0=none, 10=most severe

  2. withdrawal time [ Time Frame: 3 months ]
    from cecum to rectum excluding time for biopy and polypectomy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. patients undergoing diagnostic, screening or surveillance colonoscopy
  2. their difficult colonoscopy score(DCS) >1. DCS=1*A(1 if age≥65y, 0 if <65y) + 2*B (1 if BMI <18.5, 0 if BMI≥18.5) + 1*C(1 if colonoscopist is junior, 0 if senior)+ 1*S(1 if sleep quality was fair or bad, 0 if excellent or good).

Exclusion Criteria:

  1. history of colorectal resection;
  2. sedated colonoscopy;
  3. severe colonic stricture or obstructing tumor known before colonoscopy;
  4. current pregnancy;
  5. hemodynamic instability
  6. inability to provide informed consent.

Responsible Party: Shenzhen People's Hospital Identifier: NCT03571061     History of Changes
Other Study ID Numbers: SWI
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shenzhen People's Hospital:
water-aided colonoscopy; difficult colonoscopy