This study is NOT currently recruiting participants.
Number
08-DK-0173
Sponsoring Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 40 Years Max Age: 80 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Colonoscopy; Looping; Prevent Looping; Colon Cancer Screening; Segmental Stiffening Wire; Natural History
Recruitment Keyword(s)
None
Condition(s)
Colonoscopy; Looping; Prevent Looping; Colon Cancer Screening
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
Healthy subjects between 50 and 80 years of age and healthy subjects 40 years and older who have a family history of colon cancer may be eligible for this study.
Participants undergo colonoscopy a day after self-administering a bowel cleansing preparation. The first part of the procedure is done similarly to that of a flexible sigmoidoscopy, and no sedation or pain medication is used. The colonoscope is inserted into the rectum and advanced about one-third the length of the colon. Pain or discomfort should be mild to moderate cramping and a feeling of having to move the bowels. The subject is asked to score his or her pain level at this point using a standard pain scale. If there is pain, the procedure is stopped and an x-ray is taken to determine if the colonoscope has looped. If it has, the loop is undone and the SSW is used. Another x-ray is then taken to document that the loop has been prevented with the SSW, and the procedure is completed as per standard medical practice. Subjects are taken to the recovery area, informed of the test results and then discharged home in the care of an accompanying adult.
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INCLUSION CRITERIA: Colonoscopy is indicated based on well-established national guidelines. This includes volunteers age 50 or greater who are at average risk for colon cancer, and volunteers age 40 or greater who are at increased risk based on a personal history of colon polyps or a family history of colon polyps or cancer. Volunteer meets the criteria of Anesthesia Level 1 or 2. Volunteer agrees to undergo the study procedures. EXCLUSION CRITERIA: A. Ongoing psychiatric history including volunteers who have been hospitalized for psychiatric reasons, have missed significant number of days of work for psychiatric reasons, or who admit to suicidal ideations. B. Former or current history of alcohol or drug dependency. C. History of colonic resection. D. Pregnancy. E. Age > 80 or < 40. F. Prior radiation to the abdomen or pelvis. G. American Society of Anesthesiologists Grade 3, 4, or 5. H. Allergy or other contraindications to midazolam or fentanyl. I. Inability to tolerate preparation for procedure. J. Inability to give consent. K. Abdominal surgery within eight weeks. L. Anticoagulant therapy that cannot be interrupted. M. Diverticulitis or abdominal abscess within eight weeks. N. Colitis due to Crohn s disease, ulcerative colitis or infection.
Colonoscopy is indicated based on well-established national guidelines. This includes volunteers age 50 or greater who are at average risk for colon cancer, and volunteers age 40 or greater who are at increased risk based on a personal history of colon polyps or a family history of colon polyps or cancer.
Volunteer meets the criteria of Anesthesia Level 1 or 2.
Volunteer agrees to undergo the study procedures.
EXCLUSION CRITERIA:
A. Ongoing psychiatric history including volunteers who have been hospitalized for psychiatric reasons, have missed significant number of days of work for psychiatric reasons, or who admit to suicidal ideations.
B. Former or current history of alcohol or drug dependency.
C. History of colonic resection.
D. Pregnancy.
E. Age > 80 or < 40.
F. Prior radiation to the abdomen or pelvis.
G. American Society of Anesthesiologists Grade 3, 4, or 5.
H. Allergy or other contraindications to midazolam or fentanyl.
I. Inability to tolerate preparation for procedure.
J. Inability to give consent.
K. Abdominal surgery within eight weeks.
L. Anticoagulant therapy that cannot be interrupted.
M. Diverticulitis or abdominal abscess within eight weeks.
N. Colitis due to Crohn s disease, ulcerative colitis or infection.
Principal Investigator
Referral Contact
For more information: