Bowel Preparation for Colonoscopy in the Elderly

Study Overview
=================
Brief Summary
-----------------
The success of colonoscopy is closely related to the quality of colonic preparation. However, data regarding colonoscopy preparations in the elderly (65 years older) are scarce. Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence is lacking in this particular group of patients. Moreover, patient tolerability is a key factor for success of bowel preparation in the aged people. The purpose of this study is to compare the bowel cleansing efficacy and patient compliance of following bowel preparation methods prior to elective outpatient colonoscopy in the elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume [2L] PEG-3350 containing ascorbic acid solution.

Official Title
-----------------
Bowel Preparation With Standard 4 Liters of PEG vs. Split-dose of 4 Liters PEG vs. Split-dose of 2 Liters PEG Containing Ascorbic Acid Solutions for Outpatient Elective Colonoscopy in the Elderly: A Randomized, Colonoscopist-blinded Study

Conditions
-----------------
Bowel Preparation, Colonoscopy

Intervention / Treatment
-----------------
* Drug: Standard full-volume PEG
* Drug: Split-dose full-volume PEG
* Drug: Split-dose low-volume PEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly people aged over 65 years elective outpatient colonoscopy informed consent Exclusion Criteria: patients who had bowel movements of less than 3 per week during last one month patients who have a history of renal dysfunction (abnormal elevation of serum creatinine and electrolyte imbalance) patients who have a history of alimentary tract surgery patients who have other gastrointestinal diseases that are not suitable for undergoing colonoscopy (gastroparesis, gastric outlet obstruction, ileus, ischemic colitis, megacolon, and toxic colitis) patients classified as the American Society for Anesthesiology class III or higher Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard full-volume PEG<br> | Drug: Standard full-volume PEG<br>* Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.<br>|
| Experimental: Split-dose full-volume PEG<br> | Drug: Split-dose full-volume PEG<br>* Subjects will be asked to take 2L of PEG-3350 solution the day prior to procedure, followed by another 2L of PEG-3350 solution on the day of the procedure.<br>|
| Experimental: Split-dose low-volume PEG<br> | Drug: Split-dose low-volume PEG<br>* Subjects will be asked to take 1L of PEG-3350 containing ascorbic acid solution the day prior to procedure, followed by another 1L of PEG-3350 containing ascorbic acid solution on the day of the procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS). | The BBPS assesses cleanliness of 3 segments of the colon (ascending, transverse, and descending colon), and the total is a 10-point scale (0-9) that grades each segment of the colon from 0 to 3. In this study, adequate bowel preparation is defined as a total score 6 points or higher and individual score of 2 points or higher in each segment. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale |  | 1 year | 
| Rate of adverse events related to bowel preparation for colonoscopy | Adverse events include tenesmus, sleep disturbance, nausea, vomiting, abdominal cramping, abdominal fullness, abdominal discomfort, headache, dizziness, and others. | 1 year | 
| Number of patients who have a willingness to repeat same bowel preparation method method |  | 1 year | 
| Consumed volume of recommended bowel preparation agent based on the 3-grade scale | The 3-grade scale: optimal (100%), good (≥ 75%), and poor (< 75%) | 1 year | 
| Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale | The 3-grade scale: never, some, and much | 1 year | 
| Taste of recommended bowel preparation agent based on the 3-grade scale | The 3-grade scale: bad, neutral, and good | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cathartics, Colonoscopy, Polyethylene Glycols, Elderly