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Trial record 29 of 25842 for:    Change | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03489824
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
PUTUT BAYUPURNAMA, 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.

Condition or disease Intervention/treatment Phase
Water Immersion Method Colonoscopy in Unsedated Patients Procedure: modified- WIM colonoscopy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Colonoscopy With Modified-Water Immersion Method Colonoscopy
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: modified-water immersion method colonoscopy




Primary Outcome Measures :
  1. Abdominal discomfort score [ Time Frame: 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 :
  1. Cecal Intubation rate [ Time Frame: 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

  2. Cecal intubation time [ Time Frame: during the study ]
    Time need to insert from the anus to the cecum

  3. Time needs to pass rectosigmoid [ Time Frame: 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.

  4. Difficulties during colonoscope insertion [ Time Frame: 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)


Other Outcome Measures:
  1. Willingness to repeat the colonoscopy examination [ Time Frame: during the study ]
    0=No or 1=Yes, patient fill the questionnaire form by themselves



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489824


Contacts
Contact: PUTUT BAYUPURNAMA, MD +62274553119 pututby@yahoo.com

Locations
Indonesia
Endoscopy Room of Dr Sardjito General Hospital Recruiting
Yogyakarta, Special Province Of Yogyakarta, Indonesia, 55284
Contact: Abror         
Principal Investigator: Putut Bayupurnama, MD         
Sponsors and Collaborators
Gadjah Mada University

Responsible Party: PUTUT BAYUPURNAMA, MD, Internist-Gastroenterohepatology Consultant, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT03489824     History of Changes
Other Study ID Numbers: PB-WC003
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No