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Patient Satisfaction With Novel Double Pants Compared to Conventional Single Pants for Outpatient Colonoscopy: Prospective Randomized Study


N/A
20 Years
N/A
Open (Enrolling by invite only)
Both
Colonoscopy

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Trial Information

Patient Satisfaction With Novel Double Pants Compared to Conventional Single Pants for Outpatient Colonoscopy: Prospective Randomized Study


Eighty examinees will wear conventional single pants and another eighty examinees will wear
novel double pants randomly. Examinees who underwent colonoscopy within 3 years, with
history of bowel resection surgery, cancer, colostomy or ileostomy, psychotic disease such
as depression, anxiety disorder, obsessive disorder, treated with emergent colonoscopic
procedure, and pregnant or lactating women, an illiterate person and foreigners will be
excluded. Questionnaires before colonoscopy are educational background, martial status,
indication of colonoscopy, examinee's preference of doctor's gender, and State-trait anxiety
level of examinee. Questionnaires after colonoscopy are shame and trait anxiety level, and
satisfaction of examinee during colonoscopy. We will also investigate colonoscopy specific
quality Indicators such as the ASA status (American society of anesthesiologist's physical
status), complications, procedure success. Finally we will compare the difference of
satisfaction, shame, and anxiety during colonoscopy between examinees wearing novel double
pants and conventional single pants


Inclusion Criteria:



- patients older than 20 years who performed colonoscopy at Severance hospital

Exclusion Criteria:

- patients who underwent colonoscopy within 3 years

- patients with Psychotic problems

- patients with colostomy or ileostomy

- patients with bowel resection

- patients who needed emergent colonoscopy

- pregnant women

- lactating women

- illiterate person

- foreigners

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Outcome Measure:

Satisfaction of patients during colonoscopy

Outcome Description:

We measure the satisfaction during colonoscopy by questionnares

Outcome Time Frame:

10 minutes after colonoscopy

Safety Issue:

No

Principal Investigator

Soo Jung Park, Dr.

Investigator Role:

Study Director

Investigator Affiliation:

Severance Hospital

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

4-2011-0644

NCT ID:

NCT01524042

Start Date:

January 2012

Completion Date:

July 2012

Related Keywords:

  • Colonoscopy
  • Satisfaction
  • colonoscopy
  • double pants
  • single pants

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