Effectiveness of RL- vs LL-starting Position in Unsedated Water Immersion Colonoscopy

Study Overview
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Brief Summary
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Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients.

Detailed Description
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Abdominal discomfort is of the most important patient interest when in an unsedated colonoscopy examination. Water method for colonoscopy examination has been studied widely and evidence showed effectiveness in reducing discomfort and increase cecal intubation time and increasing cecal intubation rates in unsedated patients. Our previous studies showed that water immersion method reduced the VAS score, accelerated the intubation time significantly without different changing cecal intubation rate. Previous right-sided vs. left-sided starting position colonoscopy study in sedated patients with air insufflation colonoscopy method showed that right-sided starting position improved the abdominal discomfort score and faster cecal intubation time. We want postulate that the right-sided starting position can also maximize the water method advantages in lowering the discomfort score, faster cecal intubation time and higher cecal intubation rates, and it will improve patient acceptance of water unsedated colonoscopy and willingness to repeat.

Official Title
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The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Colonoscopy With Modified-Water Immersion Method Colonoscopy

Conditions
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Water Immersion Method Colonoscopy in Unsedated Patients

Intervention / Treatment
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* Procedure: modified- WIM colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ≥18 years old with the 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 of the need for diagnostic colonoscopy examination. Exclusion Criteria: Patients who refuse to participate, patients with obstructive lesions in the colon distal of the cecum. , patients with experienced colon resection, patients who are hemodynamically unstable, and patients with severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure ).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified-WIM colonoscopy in RLP<br>Modified-water immersion method colonoscopy is performed to patients with right-lateral starting position (RLP). Patients will lie in the right lateral position with both hips and knees flexed at the beginning and change the position into supine and at last left-lateral position when it is needed. | Procedure: modified- WIM colonoscopy<br>* Modified-water immersion method of colonoscopy refers to the freely episodic suction of the infused-water during colonoscopy insertion phase at a moment to negotiate the angulated colon to facilitate cecal intubation but not suction the mucosa. The original water immersion method only suctions the water when the colon is over-distended or it is dirty and exchanges it with the new cleans water during insertion then evacuates all of the water during withdrawal<br>* Other names: modified-water immersion method colonoscopy;|
| Active Comparator: modified-WIM colonoscopy in LLP<br>Modified-water immersion method (WIM) colonoscopy is performed to patients with left-lateral starting position (LLP). Patients will lie in the left lateral position with right hip and knee flexed and left leg straight at the beginning and change the position into supine and at last right lateral position when it is needed. | Procedure: modified- WIM colonoscopy<br>* Modified-water immersion method of colonoscopy refers to the freely episodic suction of the infused-water during colonoscopy insertion phase at a moment to negotiate the angulated colon to facilitate cecal intubation but not suction the mucosa. The original water immersion method only suctions the water when the colon is over-distended or it is dirty and exchanges it with the new cleans water during insertion then evacuates all of the water during withdrawal<br>* Other names: modified-water immersion method colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal discomfort score | The patient reported level of abdominal discomfort experienced during the colonoscopy examination. The patients will punctuate the VAS score line form by themselves, immediately after the end of examination (patient still lying on the examination bed). The VAS will be measured on a linear visual analog scale: 0=none, 10=most severe. | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal Intubation rate | The proportion of patients with successful insertion of the colonoscope to the cecum with the tip of the colonoscope touching the floor of the cecum with visualization of the medial cecal wall between the ileocecal valve and/or appendix orifice | during the study | 
| Cecal intubation time | Time need to insert from the anus to the cecum | during the study | 
| Time needs to pass rectosigmoid | Time needs to pass rectosigmoid is measured from the insertion until to when the colonoscope length passes the 40 cm sign on the colonoscope without looping. | during the study | 
| Difficulties during colonoscope insertion | Difficulties which are found during colonoscope insertion will be recorded and analyzed (e.g., looping; predominant faecal obstruction visualization level, need to use abdominal compression, need to change from starting position) | during the study |