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| Name | Class |
|---|---|
| St Vincent's Hospital | OTHER |
| Incheon St.Mary's Hospital | OTHER |
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The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hot snare polypectomy | Experimental | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique |
|
| Hot snare polypectomy(saline injection) | Experimental | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hot snare polypectomy | Procedure | hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Resection Rate | Complete resection was defined as the absence of residual polyp in the resection margin | 2 weeks after |
| Measure | Description | Time Frame |
|---|---|---|
| Lateral Margin | Observation of maring on a recsected specimen | 2 weeks after |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo-In Lee | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology; Seoul St. Mary's hospital | Seoul | 137-701 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29250580 | Background | Dwyer JP, Tan JYC, Urquhart P, Secomb R, Bunn C, Reynolds J, La Nauze R, Kemp W, Roberts S, Brown G. A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps. Endosc Int Open. 2017 Nov;5(11):E1062-E1068. doi: 10.1055/s-0043-113564. Epub 2017 Oct 27. | |
| 25708763 |
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Patients were excluded if they have (1) a bleeding tendency or ever taken antiplatelet or anticoagulation therapy within 1 week before undergoing the procedure, (2) An inflammatory bowel disease, (3) a polyposis syndrome, or (4) an inability to provide informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hot Snare Polypectomy | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps |
| FG001 | Hot Snare Polypectomy(Saline Injection) | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hot Snare Polypectomy | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps |
| BG001 | Hot Snare Polypectomy(Saline Injection) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Resection Rate | Complete resection was defined as the absence of residual polyp in the resection margin | Posted | Count of Participants | Participants | 2 weeks after |
|
2 weeks after polypectomy
Post-polypectomy bleeding was classified two categories, immediately bleeding defined as over 30 seconds continuous bleeding episode requiring any form of endoscopic hemostasis and delayed bleeding defined as between 24 hours and 2weeks after polypectomy requiring any form of endoscopic hemostasis (i.e. epinephrine injection, clipping or coagulation).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hot Snare Polypectomy | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique hot snare polypectomy: hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders | Systematic Assessment | Situations that require surgical treatment due to mucosal defects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immediate bleeding | Gastrointestinal disorders | Systematic Assessment | continuous bleeding over 30 seconds requiring any form of endoscopic hemostasis (epinephrine injection, clipping or coagulation) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bo-In Lee | Seoul ST. Mary's hospital | 821083671055 | gidoc4u@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2019 | Sep 20, 2019 | Prot_SAP_000.pdf |
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| hot snare polypectomy after saline injection | Procedure | hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps |
|
| Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048. |
| 28970290 | Background | Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28. |
| 32989532 | Derived | Kim SJ, Lee BI, Jung ES, Kim JS, Jun SY, Kim W, Ham H, Kim M, Lee SH, Lee HH, Park JM, Choi MG. Hot snare polypectomy versus endoscopic mucosal resection for small colorectal polyps: a randomized controlled trial. Surg Endosc. 2021 Sep;35(9):5096-5103. doi: 10.1007/s00464-020-07994-7. Epub 2020 Sep 28. |
Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
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| Secondary | Lateral Margin | Observation of maring on a recsected specimen | Posted | Count of Participants | Participants | 2 weeks after |
|
|
|
|
| 0 |
| 167 |
| 0 |
| 167 |
| 17 |
| 167 |
| EG001 | Hot Snare Polypectomy(Saline Injection) | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique hot snare polypectomy after saline injection: hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps | 0 | 155 | 0 | 155 | 13 | 155 |
|
|
| Delayed bleeding | Gastrointestinal disorders | Systematic Assessment | bleeding from the post-polypectomy site between 24 hours and 2 weeks after polypectomy |
|
| Post-polypectomy syndrome | Gastrointestinal disorders | Systematic Assessment |
|
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| Inconclusive |
|
| Other |