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

Not Applicable

• Conditions: Water Immersion Method Colonoscopy in Unsedated Patients
• Interventions: Procedure: modified- WIM colonoscopy

• Registration Number: NCT03489824
• Lead Sponsor: Gadjah Mada University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-02-20
• Status Verified: 2018-03
• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-03-30
• Last Update Submitted: 2018-03-30
• Study First Posted: 2018-04-06
• Last Update Posted: 2018-04-06
• Primary Completion: 2019-03
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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 ).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modified-WIM colonoscopy in RLP	modified- WIM colonoscopy	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.
modified-WIM colonoscopy in LLP	modified- WIM colonoscopy	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.

Primary Outcome Measures

Name	Time	Method
Abdominal discomfort score	during the study	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.

Secondary Outcome Measures

Name	Time	Method
Cecal Intubation rate	during the study	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
Time needs to pass rectosigmoid	during the study	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.
Difficulties during colonoscope insertion	during the study	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)
Cecal intubation time	during the study	Time need to insert from the anus to the cecum

Trial Locations

Locations (1)

Endoscopy Room of Dr Sardjito General Hospital; 🇮🇩 Yogyakarta, Special Province Of Yogyakarta, Indonesia