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Completed

NCT Number: NCT02290093

Bowel Preparation for Colonoscopy in the Elderly

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.

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Key information

Conditions

Bowel Preparation Colonoscopy

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hanyang University Guri Hospital, Guri-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard full-volume PEG

Drug

Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.

Split-dose full-volume PEG

Drug

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.

Split-dose low-volume PEG

Drug

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.

Primary outcomes

  1. Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS).

    Time frame: 1 year

    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.

Secondary outcomes

  1. Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale

    Time frame: 1 year

  2. Rate of adverse events related to bowel preparation for colonoscopy

    Time frame: 1 year

    Adverse events include tenesmus, sleep disturbance, nausea, vomiting, abdominal cramping, abdominal fullness, abdominal discomfort, headache, dizziness, and others.

  3. Number of patients who have a willingness to repeat same bowel preparation method method

    Time frame: 1 year

  4. Consumed volume of recommended bowel preparation agent based on the 3-grade scale

    Time frame: 1 year

    The 3-grade scale: optimal (100%), good (≥ 75%), and poor (< 75%)

  5. Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale

    Time frame: 1 year

    The 3-grade scale: never, some, and much

  6. Taste of recommended bowel preparation agent based on the 3-grade scale

    Time frame: 1 year

    The 3-grade scale: bad, neutral, and good

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • Hanyang University
  • Kangbuk Samsung Hospital

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2014
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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