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

Colonoscopy Clinical Trial

— SP2HP  

Official title:

Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01685970
• Other study ID #: HGI-2012-09
• Status: Recruiting
• Phase: Phase 3
• First received: September 12, 2012
• Last updated: September 14, 2012
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2012
• Source: Inje University
• Contact: Tae Oh Kim, Ph D.
• Phone: 82-51-797-0658
• Email: kto0440[@]paik.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• High volume split-dose PEG
High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
• 2 sachets of picosulfate
2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital, Inje University College of Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel preparation	Quality of bowel preparation using Ottawa bowel preparation scale	3 months	No
Secondary	Tolerability	Tolerability of bowel preparation regimen is assessed by patient questionnaire.	3 months	Yes