Pedunculated Colorectal Polyp
Conditions
Keywords
Pedunculated colorectal polyp, Underwater endoscopic mucosal resection, Hot snare polypectomy
Brief summary
A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of underwater endoscopic mucosal resection (UEMR) and hot snare polypectomy (HSP) in treating Pedunculated colorectal polyps less than 10mm in size.
Detailed description
1. Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University. 2. Randomize patients with pedunculated colorectal polyps less than 10mm 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: Hot snare polypectomy (HSP). 3. Collecting variables which consist of primary and secodary outcomes.
Interventions
The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by UEMR
PROCEDUREHot snare polypectomy
The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by HSP
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 35 and 80 years * Pedunculated colorectal polyps less than 10mm in size in screening, surveillance or therapeutic colonoscopy * 0-Isp or 0-Ip according to Paris classification * Patients must sign an informed consent form prior to registration in study
Exclusion criteria
* Unsuitable for removal by UEMR or HSP * Suspected malignancy * History of inflammatory bowel disease or colorectal resection * Familial adenomatous polyposis or Lynch syndrome * Patients taking anticoagulant and antiplatelet agents before the examination * Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale score \< 6 * ASA \>=3 * Pregnancy or breastfeeding * Severe comorbid disease involving the heart, lungs, liver, or kidneys. * Concurrent serious conditions, including other active malignancies or severe infectious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-polypectomy Bleeding | 2 weeks after the procedure | Presence of Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB） or Clinically Significant Delayed Post-polypectomy Bleeding (CSDPB). CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis. CSDPB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative electrocoagulation syndrome | 2 weeks after the procedure | Postoperative electrocoagulation syndrome （PEECS）defined as localized abdominal tenderness plus at least one of the following: (1) body temperature \> 37.6 °C; (2) white-blood-cell count \> 10 × 10⁹ /L; or (3) C-reactive protein \> 0.5 mg/dL, after ruling out delayed postoperative perforation). |
| en bloc resection | immediately after the procedure | Rate of en bloc resection rate |
| R0 resection | 2 weeks after the procedure | Rate of R0 resection |
| Delayed perforation | 2 weeks after the procedure | Rate of delayed perforation |
Countries
China
Contacts
Primary ContactZhiyu Dong, M.D.
Backup ContactDanian Ji, M.D.
Outcome results
None listed