TCTR20230411007CompletedPhase 3
Combination Lubiprostone and Split-Dose PEG-ELS Vs Split-Dose PEG-ELS alone for bowel preparation before colonoscopy in constipated patients: A prospective, endoscopist-blinded, randomized controlled trial
Dr. Kawin Tangvoraphonkchai0 sites68 target enrollmentStarted: April 11, 2023Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 68
Study Overview
Brief Summary
The rate of adequate bowel cleaning was comparable between PEG-ELS plus Lubiprostone group and PEG-ELS alone group (50% vs 52.9% respectively p-value 0.81) with relative risk 1.13 (95% CI 0.43 - 2.91). There was no significant difference in adenoma detection rate (41.2 % vs 35.3 % respectively, p-value 0.62), adverse events, acceptance, compliance, and patient satisfaction between the 2 groups.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •18-75 years of age patients that are indicated for colonoscopy with constipation (Compatible with ROME IV diagnostic criteria for chronic constipation or history of Bristol stool form scale 1-2).
Exclusion Criteria
- •Suspected bowel obstruction or perforation, uncontrolled condition e.g. congestive heart failure, unstable angina pectoris, unstable hypertension, cardiac arrhythmia, liver failure, acute kidney injury, uncontrolled blood glucose, hypo-hyperthyroid state, cannot stop warfarin for 3 days, cannot stop antiplatelet for 7 days, history of colectomy, pregnancy or breastfeeding, history of drug allergy for PEG-ELS or Lubiprostone, coagulopathy(INR > 1.5), and thrombocytopenia (< 50000 /ul).
Investigators
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