Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps
Authors: Akeel Halai
Benjamin Chebaa
Leon Kundrotas
Ranjan Mascarenhas
William V Harford
Stuart J Spechler
Daisha J Cipher
Andrew D Smith
Tisha Lunsford
Daniel Kim
Kerry B Dunbar
Suneetha Duttala
John Vizuete
Miriam Mara
Rabia Meghani
Linda A Feagins
Journal: Gastroenterology (2019)
Discipline: CLINICAL MEDICINE
Keywords: Colonoscopy; Gastrointestinal Hemorrhage; Polypectomy.
Affiliations: Department of Medicine, Veterans Affairs North Texas Healthcare System, Dallas, Texas; Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: ., Department of Medicine, Veterans Affairs North Texas Healthcare System, Dallas, Texas., Department of Medicine, South Texas Veterans Healthcare System, San Antonio, Texas; Department of Medicine, University of Texas San Antonio Health Sciences Center, San Antonio, Texas., Department of Medicine, South Texas Veterans Healthcare System, San Antonio, Texas., Department of Medicine, Central Texas Veterans Healthcare System, Austin Outpatient Clinic, Austin, Texas; Department of Medicine, Dell Medical School, The University of Texas at Austin, Austin, Texas., Department of Medicine, Central Texas Veterans Healthcare System, Austin Outpatient Clinic, Austin, Texas., Department of Medicine, Veterans Affairs North Texas Healthcare System, Dallas, Texas; Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas., The College of Nursing and Health Innovation, University of Texas at Arlington, Arlington, Texas., Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.

Abstract:  Background &amp; 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. 

Retracted: No

PubPeer comments:
 Post-polypetomy bleeding (PPB) is a common complication after endoscopic resection of large colonic polyps. In [German guidelines ] , a prophylactic hemostasis procedure after polypectomy is recommended in individual cases, depending on the individual risk constellation. However, it has not been conclusively clarified whether routine closure of the ablation sites by endoscopically placed clips can effectively reduce the risk of PPB. Feagins et al. now conducted a randomized controlled multicenter study (RCT) in a total of 1,098 patients with elective colonoscopy and resection of at least one large polyp (u22651 cm), which compared prophylactic clipping with a procedure without clip placement. Interestingly, the allocation to the treatment arms took place immediately after polypectomy. This was intended to minimise the bias of the treating physician. For the primary endpoint of a delayed PPB within 30 days after polypectomy there was no statistically significant difference between the intervention group and the control group. The results remained constant even after control of possible confounders such as anticoagulant use, polyp localization (proximal vs. distal), polyp size (u22652 cm), polyp morphology (stalked vs. sessile) and resection technique. In contrast to this, [the RCT by Pohl et al.] , also recently published in *Gastroenterology*, compared the clipping procedure with a procedure without clip placement on 919 patients with polyps u22652 cm. The total PPB rate was reduced from 7.1% to 3.5% by clipping. However, this effect was mainly seen in right colonic localization of the polyp. Furthermore, no tests were performed for confounding by the intake of anticoagulants or platelet aggregation inhibitors, which were taken more frequently by the patients of the control group. Complete closure of the resection site by clip was only possible in about 2 3 of the cases. The mean number of used clips per polyp was 4 (IQR 3-6). ,