Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShandong University

About this trial

This was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. The primary outcome was delayed postpolypectomy bleeding. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-80 years old, male and female

Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp

Disqualifiers

Contraindication to colonoscopy or polypectomy

Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy

Alarming signs and symptoms of colorectal cancer (blood in stool, black stool, unexplained anaemia and weight loss, abdominal mass, positive rectal examination; or imaging and laboratory tests highly suspicious for colorectal cancer) or endoscopic manifestations of polyps highly suspicious for high-grade intraepithelial neoplasia or carcinoma

Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • cold snare polypectomy

    Procedure/Surgery

    Cold snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.

  • hot snare polypectomy

    Procedure/Surgery

    Hot snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.

Treatment groups

196 Participants
are divided into 2 treatment groups
Group A: cold snare polypectomy groupExperimental treatment 1 intervention
Group B: hot snare polypectomy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

delayed postoperative bleeding

bleeding that developed within 2 weeks after the patient left the endoscopy unit

Time frame
interviewed by telephone on days 2 and 14 after polypectomy

Secondary outcomes

1

immediate postpolypectomy bleeding

Blood spray or persistent oozing for more than 60 seconds requiring endoscopic intervention

Time frame
during the polypectomy
2

procedure time

The duration from the appearance of the snare on the monitor to the time when the endoscope was withdrawn from the lesion

Time frame
during the polypectomy
3

en bloc resection

Removal of a polyp with a single cut and was assessed by the colonoscopist

Time frame
during the polypectomy
4

complete histologic resection

Clear resection margins, no polyp involvement

Time frame
during the polypectomy

Other outcomes

Sponsors and contacts

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