Clinical trial NCT03489824: Effectiveness of RL- vs LL-starting Position in Unsedated Water Immersion Colonoscopy
Official title: The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Colonoscopy With Modified-Water Immersion Method Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Water Immersion Method Colonoscopy in Unsedated Patients
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 ).

Primary outcomes:
measure: Abdominal discomfort score
timeFrame: during the study
Secondary outcomes:
measure: Cecal Intubation rate
timeFrame: during the study
measure: Cecal intubation time
timeFrame: during the study
measure: Time needs to pass rectosigmoid
timeFrame: during the study
measure: Difficulties during colonoscope insertion
timeFrame: during the study
Other outcomes:
measure: Willingness to repeat the colonoscopy examination
timeFrame: during the study
Locations:
city: Yogyakarta
country: Indonesia
facility: Endoscopy Room of Dr Sardjito General Hospital
state: Special Province Of Yogyakarta
Study officials:
References:
citation: 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.