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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03489824
• Date of registration: 30/03/2018
• Prospective Registration: No
• Primary sponsor: Gadjah Mada University
• Public title: Effectiveness of RL- vs LL-starting Position in Unsedated Water Immersion Colonoscopy RLPvsLLP
• Scientific title: The Effectiveness of Right- vs Left-lateral Starting Position in Unsedated Colonoscopy With Modified-Water Immersion Method Colonoscopy
• Date of first enrolment: February 20, 2018
• Target sample size: 142
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03489824
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Indonesia

Contacts

• Name: Abror

• Name: PUTUT BAYUPURNAMA, MD

Key inclusion & exclusion 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 ).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Water Immersion Method Colonoscopy in Unsedated Patients

Intervention(s)

Procedure: modified- WIM colonoscopy

Primary Outcome(s)

Abdominal discomfort score [Time Frame: during the study]

Secondary Outcome(s)

Cecal Intubation rate [Time Frame: during the study]

Cecal intubation time [Time Frame: during the study]

Difficulties during colonoscope insertion [Time Frame: during the study]

Time needs to pass rectosigmoid [Time Frame: during the study]

Secondary ID(s)

PB-WC003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors