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

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ClinicalTrials.gov Identifier: NCT03571061
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : January 1, 2019
Sponsor:
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 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).


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual 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 Carbon Dioxide (CO2) Insufflation on Cecal Intubation Time in Potentially Difficult Colonoscopy by Difficult Colonoscopy Score(DCS) >1.
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : November 26, 2018
Actual Study Completion Date : December 26, 2018

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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 carbon dioxide (CO2) insufflation.
Other Name: carbon dioxide (CO2) 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 carbon dioxide (CO2) insufflation.
Other Name: carbon dioxide (CO2) insufflation

Placebo Comparator: carbon dioxide (CO2) insufflation
carbon dioxide (CO2) insufflation group: carbon dioxide (CO2) 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 carbon dioxide (CO2) insufflation.
Other Name: carbon dioxide (CO2) 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



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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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571061


Locations
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China, Guangdong
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518000
Sponsors and Collaborators
Shenzhen People's Hospital

Publications:
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Responsible Party: Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT03571061     History of Changes
Other Study ID Numbers: SWI
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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