Cold Snare,Hot Snare and APC Polypectomy for the Complete Removal of Small Left Sided Colon Polyps

Study Overview
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Brief Summary
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Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare cold snare vs hot snare vs argon plasma coagulation for the compete removal of colonic polyps of the left colon up to a diameter of 0.8cm.

Detailed Description
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Adenomatous polyps are the most common neoplastic findings discovered in subjects who undergo colonoscopy either for colorectal screening or during a diagnostic work-up for symptoms. Currently small polyps 0.3-0.8cm are removed using hot snare polypectomy (HSP) cold snare polypectomy (CSP) while argon plasma coagulation (APC) has been proposed for the cauterization of bigger polyps (Melt Effect) Endoscopic polypectomy is associated with potential complications, i.e. perforation and bleeding while some polyps may recur after polypectomy. Given the limited existing data regarding the advantages and limitations of the existing techniques in the removal of colonic polyps the investigators designed a prospective study in order to compare the above mentioned methods for the compete removal of colonic polyps 0,3-0,8 cm from the left side colon. METHODS The study will be conducted in the endoscopy unit of Evangelismos Hospital and in D Surgical clinic of the University Hospital Attikon.All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm will be prospectively randomized to three groups. CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP. HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function. APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min. All polyps will be elevated by submucosal injection of normal saline (1ml) and consequently a special dye (1ml) containing carbon particles (Spot) before applying any of the three removal techniques. The injection solution protects from thermal injury of deeper layers during the application of current and APC,also the injection of the dye (tattoo) at the polypectomy, ensures that the endoscopist will detect the point of polypectomy in the follow up colonoscopy after 3-6 months. Spot (GI supply,Camp Hill,PA) is the only commercially available suspension for endoscopic tattooing approved by the Food and Drug Association (FDA). It contains prediluted sterile syrings that are filled with highly purified fine carbon particles ready for endoscopic use. The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD). Statistical analysis showed that the sample required to give medium (W = 0.3) the difference between the three groups is 108 patients, with significance level of 5% and validity of the study 80% All patients included in the study will undergo a repeat colonoscopy in a 3-6 month time period. The endoscopist based on tattoos have been received on the first endoscopy during polypectomy will receive multiple biopsies from the point, which will be sent for histological examination.The pathologist will then examine the tissue sample and will define whereas the polyp has been completely eradicated or recurred.

Official Title
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Cold Snare Polypectomy vs Hot Snare Polypectomy vs APC for the Complete Removal of Left Sided Colon Polyps. A Prospective,Randomized Trial

Conditions
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Colonic Polyps

Intervention / Treatment
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* Procedure: polypectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive patients with colorectal polyps of the left colon (up to the splenic flexure) with a diameter of 0.3-0.8cm. Exclusion Criteria: The study excluded patients with a history of familial polyposis (FAP), Gardner's syndrome, Peutz-Jeghers syndrome, patients with colon Cancer as well as patients with idiopathic inflammatory bowel disease (IBD).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cold snare polypectomy<br>CSP: In this group polyps will be removed with the cold snare polypectomy technique, as a single piece. Additionally, a 1-2mm of normal tissue around the small polyp will also be ensnared in the CSP. | Procedure: polypectomy<br>* Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.<br>* Other names: colonoscopy;|
| hot snare polypectomy<br>HSP: In this group polyps will be removed with the hot snare polypectomy technique as a single piece with a electrosurgical snare and monopolar current with a setting of 30-35 W in the endocut function. | Procedure: polypectomy<br>* Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.<br>* Other names: colonoscopy;|
| APC polyp destruction-polypectomy<br>APC: In APC group polyps will be cauterized by application of high power argon plasma coagulation on small waves at 50-60W and flow at 2lt/min,as result the polyp destruction. | Procedure: polypectomy<br>* Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.<br>* Other names: colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete removal of colonic polyps | The resections margin of the polyp was isolated from the rest of the polyp,stained with black and examined through multiple histological sections in order to certify that no dysplastic cells were traced upon the resection margin.Since all adenoma cases exhibited low grade epithelial dysplasia, as positive margin was considered the presence of dysplastic cell exactly upon the resection margin/black ink. | at 6 months after polypectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APC, cold snare polypectomy, hot snare polypectomy