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

Water Immersion Method Colonoscopy in Unsedated Patients Clinical Trial

— RLPvsLLP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03489824
• Other study ID #: PB-WC003
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2018
• Last updated: March 30, 2018
• Start date: February 20, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2018
• Source: Gadjah Mada University
• Contact: PUTUT BAYUPURNAMA, MD
• Phone: +62274553119
• Email: pututby[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: June 30, 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ).

Related Conditions & MeSH terms

• Water Immersion Method Colonoscopy in Unsedated Patients

Intervention

Procedure:
• modified- WIM colonoscopy
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

Locations

Country	Name	City	State
Indonesia	Endoscopy Room of Dr Sardjito General Hospital	Yogyakarta	Special Province Of Yogyakarta

Sponsors (1)

Lead Sponsor	Collaborator
Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Willingness to repeat the colonoscopy examination	0=No or 1=Yes, patient fill the questionnaire form by themselves	during the study
Primary	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	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
Secondary	Cecal intubation time	Time need to insert from the anus to the cecum	during the study
Secondary	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
Secondary	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