Abstract | BACKGROUND & AIMS: The efficacy of prophylactic placement of hemoclips to prevent delayed bleeding after removal of large colonic polyps has not been established. We conducted a randomized equivalence study to determine whether prophylactic placement of hemoclips affects incidence of delayed post-polypectomy bleeding (PPB). METHODS: During elective colonoscopy performed at 4 Veterans Affairs Medical Centers, 1098 patients who had polyps ≥1 cm removed were randomly assigned to groups that received prophylactic hemoclips (n = 547) or no hemoclips (n = 551), from September 2011 through September 2018. Data on PPB (rectal bleeding resulting in hemoglobin decreases ≥2 g/dL, hemodynamic instability, colonoscopy, angiography, or surgery) within 30 days of colonoscopy (called delayed PPB) were collected during telephone interviews or hospital visits 7 and 30 days after colonoscopy. The primary outcome was the incidence of important post-polypectomy bleeding. RESULTS: Twelve patients in the hemoclip group (2.3%) and 15 patients in the no hemoclip group (2.9%) had important delayed PPB. There were no deaths, and no patients in either group required angiography or surgery. In intention-to-treat analysis, two 1-sided test's lower and upper confidence interval limits were -2.07 and 1.01, indicating that the data approached but did not meet equivalence criteria. On multiple logistic regression analysis, significant predictors of PPB included use of warfarin with bridging, thienopyridines, polyp size, and polyp location, but hemoclip placement did not associate with important delayed PPB. CONCLUSIONS: In a randomized trial, we found that prophylactic placement of hemoclips after removal of large colon polyps does not affect the proportion of important delayed PPB events, compared with no hemoclip placement. These findings call into question the widespread, expensive practice of routinely placing prophylactic hemoclips after polypectomy. ClinicalTrials.gov ID: NCT01647581.
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Authors | Linda A Feagins, Andrew D Smith, Daniel Kim, Akeel Halai, Suneetha Duttala, Benjamin Chebaa, Tisha Lunsford, John Vizuete, Miriam Mara, Ranjan Mascarenhas, Rabia Meghani, Leon Kundrotas, Kerry B Dunbar, Daisha J Cipher, William V Harford, Stuart J Spechler |
Journal | Gastroenterology
(Gastroenterology)
Vol. 157
Issue 4
Pg. 967-976.e1
(10 2019)
ISSN: 1528-0012 [Electronic] United States |
PMID | 31158369
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S.)
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Copyright | Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Topics |
- Colectomy
(adverse effects, methods)
- Colonic Polyps
(pathology, surgery)
- Colonoscopy
(adverse effects)
- Equipment Design
- Female
- Hemostatic Techniques
(adverse effects, instrumentation)
- Humans
- Male
- Middle Aged
- Postoperative Hemorrhage
(etiology, prevention & control)
- Prospective Studies
- Risk Factors
- Surgical Instruments
- Time Factors
- Treatment Outcome
- United States
- United States Department of Veterans Affairs
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