The Water Method Colonoscopy in Routine Unsedated Colonoscopy Examinations

NCT ID: NCT01341847

Last Updated: 2012-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-06-30

Brief Summary

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.

Conditions

Colonoscopy Diagnostic Techniques and Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Water method colonoscopy

This technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of 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

Group Type: ACTIVE_COMPARATOR

water method colonoscopy

Intervention Type: PROCEDURE

This technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of colonoscope during insertion since the scope is inserted into the anus until reach the cecum.

air method colonoscopy

This technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers.

Group Type: OTHER

air method colonoscopy

Intervention Type: PROCEDURE

This technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers.

Interventions

water method colonoscopy

This technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of colonoscope during insertion since the scope is inserted into the anus until reach the cecum.

Intervention Type: PROCEDURE

air method colonoscopy

This technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gadjah Mada University

OTHER

Sponsor Role: lead

Responsible Party

PUTUT BAYUPURNAMA

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Putut Bayupurnama, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, Gadjah Mada University/Sardjito General Hospital, Yogyakarta, Indonesia

Locations

Endoscopy Room of Dr Sardjito General Hospital

Yogyakarta, Special Province of Yogyakarta, Indonesia

Countries

Indonesia

Other Identifiers

PB-63

Identifier Type: -

Identifier Source: org_study_id