Colorectal Polyp, Colorectal Neoplasms
Conditions
Keywords
colorectal polyp, underwater endoscopic mucosal resection, conventional endoscopic mucosal resection
Brief summary
A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps
Detailed description
* Patients are undergone colonoscopy at the Endoscopy department of Ho Chi Minh City University Medical Center. * Randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Underwater endoscopic mucosal resection (UEMR) and (2) Group 2: Conventional endoscopic mucosal resection (CEMR). * The time of local recurrence assessment depends on the histopathology of polyps. Polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months. * Collecting variables which consist of primary and secodary outcomes.
Interventions
PROCEDUREEndoscopic resection
Group 1: Polyps are resected by UEMR Group 2: Polyps are resected by CEMR
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Non-pedunculated polyps of 10 mm or more in size * Type 1 or 2 according to NBI International Colorectal Endoscopy (NICE) classification * Patients must sign an informed consent form prior to registration in study
Exclusion criteria
* Lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive non-lifting sign) * Type 3 according to NICE classification * Colorectal cancer * Patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease) * Hemostasis disorder (INR \> 1.5; platelets \< 100000/mm3)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| en bloc resection | immediately after the procedure | Rate of en bloc resection for non-pedunculated colorectal polyps of 10 mm or more |
| Curative rate | through study completion, an average of 6 months | Curative rate for non-pedunculated colorectal polyps of 10 mm or more |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | up to 2 weeks | Rate of complications including bleeding, perforation |
| Local recurrence rate | 6 months | Rate of local recurrence |
| Procedure time | during the procedure | Time for complete resection of polyps |
Countries
Vietnam
Outcome results
None listed