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

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

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.

Study Overview

• Status: Unknown
• Conditions: Water Immersion Method Colonoscopy in Unsedated Patients
• Intervention / Treatment: Procedure: modified- WIM colonoscopy

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 Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PUTUT BAYUPURNAMA, MD; Phone Number: +62274553119; Email: pututby@yahoo.com

Study Locations

• Indonesia
  • Special Province Of Yogyakarta
    • Yogyakarta, Special Province Of Yogyakarta, Indonesia, 55284
      • Recruiting
      • Endoscopy Room of Dr Sardjito General Hospital
      • Contact: Abror
      • Principal Investigator: Putut Bayupurnama, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified-WIM colonoscopy in RLP; 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; 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; Other Names: modified-water immersion method colonoscopy
Active Comparator: modified-WIM colonoscopy in LLP; 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; 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; Other Names: modified-water immersion method colonoscopy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Willingness to repeat the colonoscopy examination	0=No or 1=Yes, patient fill the questionnaire form by themselves	during the study

Collaborators and Investigators

• Sponsor: Gadjah Mada University

Publications and helpful links

General Publications

• Bayupurnama P, Ratnasari N, Indrarti F, Triwikatmani C, Maduseno S, Nurdjanah S, W Leung F. The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Diagnostic Colonoscopy with Modified-water Immersion Method: A Randomized Controlled Trial Study. Clin Exp Gastroenterol. 2020 Sep 24;13:369-375. doi: 10.2147/CEG.S270793. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PB-WC003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No