Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy. (CCF)

• ClinicalTrials.gov Identifier: NCT00687830
• Recruitment Status: Completed
• First Posted: June 2, 2008
• Results First Posted: April 11, 2016
• Last Update Posted: May 17, 2017
• Sponsor: Cleveland Clinic Florida
• Information provided by (Responsible Party): The Cleveland Clinic ( Cleveland Clinic Florida )

Study Description

Brief Summary:

The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.

Condition or disease	Intervention/treatment	Phase
Colon Cancer	Drug: Polyethylene Glycol afternoon; Drug: Polyethylene Glycol morning	Phase 3

Detailed Description:

Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: A Randomized Endoscopist-blinded Clinical Trial Comparing the Bowel Cleansing Effect and Patient Tolerability of Same Day Polyethylene Glycol Bowel Preparation Regimen v Regimen Given on the Day Before Colonoscopy
• Study Start Date: February 2008
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Polythylene Glycol (PEG) in the evening; Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. 'Polyethylene Glycol afternoon'	Drug: Polyethylene Glycol afternoon; Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM; Other Name: GoLytely
Experimental: Polythylene Glycol (PEG) in the Morning; Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. 'Polyethylene Glycol morning'	Drug: Polyethylene Glycol morning; Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM; Other Name: Golytely

Outcome Measures

Primary Outcome Measures :

1. Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome. [ Time Frame: Within 1 hr after the colonoscopy procedure ]

Secondary Outcome Measures :

1. Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep. [ Time Frame: An hour before the colonoscopy procedure ]
   Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon.

Exclusion Criteria:

• Colonoscopy is contraindicated
• Prior Colectomy or colon surgery.

Contacts and Locations

Locations

United States, Florida

Cleveland Clinic Florida

Weston, Florida, United States, 33331

Sponsors and Collaborators

Cleveland Clinic Florida

Investigators

• Principal Investigator: Shibu Varughese, M.D.; Cleveland Clinic Florida

More Information

Additional Information:

European society of GI endoscopy guidelines on bowel preparation. Reference 61, Page 145 : Same day regimen. 

Publications of Results:

Varughese S, Kumar AR, George A, Castro FJ. Morning-only one-gallon polyethylene glycol improves bowel cleansing for afternoon colonoscopies: a randomized endoscopist-blinded prospective study. Am J Gastroenterol. 2010 Nov;105(11):2368-74. doi: 10.1038/ajg.2010.271. Epub 2010 Jul 6.

• Responsible Party: Cleveland Clinic Florida
• ClinicalTrials.gov Identifier: NCT00687830
• Other Study ID Numbers: CCFL-8964
• First Posted: June 2, 2008
• Results First Posted: April 11, 2016
• Last Update Posted: May 17, 2017
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by The Cleveland Clinic ( Cleveland Clinic Florida ):

Afternoon colonoscopy; Morning; Evening; Bowel Preparation; Efficacy; Satisfaction

Additional relevant MeSH terms:

Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases