Colonoscopy Diagnostic Techniques and Procedures Clinical Trial
Official title:
The Water Method Colonoscopy in Routine Unsedated Colonoscopy Examinations : A Randomized Controlled Trial(RCT) in Diagnostic Cases in Indonesian Patients
Aim of the Study :
This study will compare the colonoscopy examination between the air method (air
insufflation) and water method (water infusion) in unsedated patients with indication
(symptoms and signs based) of colonoscopy examination. This study is based on earlier study
which showed that water method had better results in reducing abdominal pain, caecal
intubation and patients willingness to repeat colonoscopy examination than air method.
Background:
Colonoscopy examination is an important method to examine and establish the diagnosis of
various diseases in the colon. Colonoscopy is successful when the tip of the scope reach the
cecum and observe the caecal valve and/ or appendix orifice. This examination can be
performed unsedated or under sedation (conscious sedation or deep sedation/general
anaesthesia). The main disadvantage of unsedated colonoscopy method is the abdominal
discomfort or pain during examination that may make patient distress and hemodynamically
unstable and possibly stoppage of the examination before reach the cecum, but the severity
of abdominal symptoms is vary from patient to patient. Many efforts have been tried to
reduce the abdominal discomfort during examination. This unsedated method with air
insufflation is our hospital standard method for colonoscopy examination since early 1980s,
and less than 1% of patients were colonoscopied with conscious or deep sedation. Our study
showed the success rate of this standard unsedated method was about 82%. The advantage of
this method is inexpensive (feasible for most of people in developing country like us),
patient may be examined ambulatory without escort, may back to work as soon as the
examination is finished. Studies showed that replace the air insufflation with water
infusion into colon since the beginning of the examination increased the success rate of
caecal intubation and reduced the abdominal pain symptoms during colonoscopy examination(1).
Sedation or general anaesthesia may increase the success rate of colonoscopy examination but
it is costly, and may increase the adverse event especially in the elderly or patients with
significance cardiopulmonary problems.
Research Design and Methods:
Eligible patients in the hospital clinics or wards will be offered to follow unsedated
colonoscopy examination. The principle investigator (PI) will explain the study, the
colonoscopy procedure , the various symptoms that may be felt during examination, the
possible adverse event and medical effort to prevent it. Patient who sign the informed
consent will be included in the study.
Methods on the day of exam. Enrolled patients will be sent to the endoscopy room and
colonoscopy will be performed by the principle investigator. Patient lie on the left lateral
position with right hip and knee flexed and left leg straight. When the PI about to start
the single-handed colonoscopy examination, the blinded observer open the sealed envelops
with the code enclosed. A standard colonoscope will be inserted. Patient may be ordered to
change the position and or abdominal compression may be applied by nurse to aid the
colonoscope advancement. Oximetry, cardiac rhythm and blood pressure will be monitored
during examination. Blinding will not be performed in this study because of the feeling of
water or air effect inside the colon can be differentiated by the patient so that in our
opinion it actually can not be blinded..The control method includes usual air insufflation
during insertion and shortening maneuvers. The study method includes only water infusion
(air pump is turned off) through the colonoscope during insertion since the scope is
inserted into the anus until reach the cecum. Water will be infused as needed under
endoscopist judgement through the adaptor on biopsy channel with endoscopic washer pump. The
usual air insufflation will be used during colonoscope withdrawal to facilitate mucosal
examination and perform any other intervention, such as biopsy. Hypothesis testing: The
unsedated colonoscopy with natural temperature water infusion minimize the pain symptoms
than unsedated colonoscopy with usual air insufflation.
| Status | Completed |
| Enrollment | 110 |
| Est. completion date | June 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult > 18 years old with indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative for colonoscopy examination Exclusion Criteria: - Patients refuse to participate - Patient with obstructive lesion in the colon distal of the cecum, - Patients with experienced of colon resection, hemodynamically unstable,severe cardiac disorders (such as acute myocardial infarction,unstable angina,malignant arrhythmia, and moderate to severe congestive heart failure, - Patients with fecal obstruction (whatever the cause) so that impossible to pass the scope through the obstructed segment; - Patients with communication problems. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | Endoscopy Room of Dr Sardjito General Hospital | Yogyakarta | Special Province of Yogyakarta |
| Lead Sponsor | Collaborator |
|---|---|
| Gadjah Mada University |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Abdominal discomfort score | The level of abdominal discomfort experienced by the patient during the colonoscopy examination and reported to a blinded observer shortly before discharge (5 to 10 minutes after colonoscopy) will be measured on a linier visual analog scale :0=none, 10= most severe | one year | No |
| Secondary | Cecal Intubation | Touching the tip of the colonoscope to the cecum with visualization of the ileocecal valve and/or appendix orifice | one year | No |