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Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy (SP2HP)

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ClinicalTrials.gov Identifier: NCT01685970
Recruitment Status : Unknown
Verified September 2012 by Eun Hee Seo, MD, Inje University.
Recruitment status was:  Recruiting
First Posted : September 17, 2012
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, MD, Inje University

Brief Summary:

Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.


Condition or disease Intervention/treatment Phase
Colonoscopy Drug: High volume split-dose PEG Drug: 2 sachets of picosulfate Phase 3

Detailed Description:

Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy
Study Start Date : September 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: High volume Split-dose PEG
Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation
Drug: High volume split-dose PEG
High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
Other Name: Polyethylene glycol(Colyte)
Active Comparator: 2 sachets of picosulfate
Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.
Drug: 2 sachets of picosulfate
2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy
Other Name: sodium picosulfate



Primary Outcome Measures :
  1. Quality of bowel preparation [ Time Frame: 3 months ]
    Quality of bowel preparation using Ottawa bowel preparation scale


Secondary Outcome Measures :
  1. Tolerability [ Time Frame: 3 months ]
    Tolerability of bowel preparation regimen is assessed by patient questionnaire.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms

Exclusion Criteria:

  • pregnancy,
  • breast feeding,
  • prior history of surgical large bowel resection,
  • severe medical condition such as severe cardiac,
  • hepatic, or
  • renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
  • significant gastric paresis or gastric outlet obstruction or ileus,
  • known or suspected bowel obstruction or perforation,
  • drug addiction or major psychiatric illness,
  • allergy to PEG and refusal to participate in the study

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): NCT01685970


Contacts
Contact: Tae Oh Kim, Ph D. 82-51-797-0658 ext 0658 kto0440@paik.ac.kr
Contact: Eun Hee Seo, MD 82-51-797-0220 ext 0220 arate98@naver.com

Locations
Korea, Republic of
Haeundae Paik Hospital, Inje University College of Medicine Recruiting
Busan, Korea, Republic of, 612-030
Contact: Eun Hee Seo, MD    82-51-797-0220 ext 0220    arate98@naver.com   
Contact: Tae Oh Kim, Ph D    52-51-797-0658 ext 0658    kto0440@paik.ac.kr   
Principal Investigator: Eun Hee Seo, MD         
Sponsors and Collaborators
Inje University
Investigators
Study Director: Tae Oh Kim, Ph D Haeundae Paik Hospital, Inje University College of Medicine

Responsible Party: Eun Hee Seo, MD, Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for aternoon colonoscopy, Inje University
ClinicalTrials.gov Identifier: NCT01685970     History of Changes
Other Study ID Numbers: HGI-2012-09
First Posted: September 17, 2012    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Eun Hee Seo, MD, Inje University:
Bowel preparation
colonoscopy
polyethylene glycol
picosulfate

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents