UEMR Versus HSP in the Treatment of Pedunculated Colorectal Polyps Less Than 10mm in Size

N/ANot Yet RecruitingNCT06996522

Fudan University338 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

338

Conditions

Pedunculated Colorectal Polyp

Interventions

underwater endoscopic mucosal resectionPROCEDURE

The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by UEMR

Hot snare polypectomyPROCEDURE

The Pedunculated colorectal polyps less than 10mm in size in this group will be treated by HSP

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Huadong hospital affiliated to Fudan university

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Post-polypectomy Bleeding

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).

Time frame: 2 weeks after the procedure

Secondary Outcomes

postoperative electrocoagulation syndrome

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).

Time frame: 2 weeks after the procedure

en bloc resection

Rate of en bloc resection rate

Time frame: immediately after the procedure

R0 resection

Rate of R0 resection

Time frame: 2 weeks after the procedure

Delayed perforation

Rate of delayed perforation

Time frame: 2 weeks after the procedure