{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T13:26:29Z","timestamp":1790774789425,"version":"4.1.0"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2022,5,27]],"date-time":"2022-05-27T00:00:00Z","timestamp":1653609600000},"content-version":"vor","delay-in-days":25,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Helios Center for Research and Innovation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Symptomatic haemorrhoids are a common anorectal disorder. The aim of the study was to investigate whether the omission of tamponade dressings after haemorrhoidectomy reduces postoperative pain without increasing the risk of severe bleeding.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Method<\/jats:title>\n                  <jats:p>This was an open-label, randomized clinical trial conducted at 14 German hospitals. All patients with third- or fourth-degree haemorrhoids undergoing haemorrhoidectomy were considered eligible for selection in the intervention (no dressing) or control group (tamponade applied). Two co-primary outcomes were analysed by testing hierarchically ordered hypotheses. First, maximum pain intensity within 48\u2005h after surgery was compared between the groups (superiority). This was followed by an analysis of severe bleeding complications, defined as any bleeding requiring surgical re-intervention within 7 days (non-inferiority). Secondary outcomes included health-related quality of life, patient satisfaction, haemoglobin levels, and adverse events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Out of 950 patients screened, 754 were randomized and 725 received intervention (366 patients in the intervention and 359 patients in the control group). In the group with tamponade dressings, median pain intensity on the 0 to 10 scale was 6 (interquartile range (i.q.r.) 4\u20137). Patients without tamponade dressings reported significantly less pain (median 5 (i.q.r. 3\u20137), P\u2009&amp;lt;\u20090.001). In each group, five patients (1.4 per cent) experienced severe bleeding. The absolute difference for the severe bleeding rate was \u22120.03 per cent with the 90 per cent confidence interval ranging from \u22121.47 per cent to +1.41 per cent, in line with the non-inferiority aim. No significant between-group difference was found for secondary outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The practice of inserting tamponade dressings after haemorrhoidectomy correlates with increased postoperative pain and does not provide benefits in terms of reduced postoperative bleeding.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Registration number<\/jats:title>\n                  <jats:p>DRKS00011590<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjsopen\/zrac070","type":"journal-article","created":{"date-parts":[[2022,4,17]],"date-time":"2022-04-17T11:06:30Z","timestamp":1650193590000},"source":"Crossref","is-referenced-by-count":7,"title":["Tamponade dressing versus no dressing after haemorrhoidectomy: multicentre, randomized clinical trial"],"prefix":"10.1093","volume":"6","author":[{"given":"Mike Ralf","family":"Langenbach","sequence":"first","affiliation":[{"name":"Ev. Krankenhaus Lippstadt, Department of Surgery II, University of Witten\/Herdecke , Lippstadt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Razvan-Valentin","family":"Florescu","sequence":"additional","affiliation":[{"name":"Helios St. Elisabeth Klinik Oberhausen, Department of Surgery II, University of Witten\/Herdecke , Oberhausen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"K\u00f6hler","sequence":"additional","affiliation":[{"name":"Helios Klinikum Duisburg , Duisburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Barkus","sequence":"additional","affiliation":[{"name":"Helios Klinikum Niederberg , Velbert, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg-Peter","family":"Ritz","sequence":"additional","affiliation":[{"name":"Helios Klinikum Schwerin , Schwerin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduart","family":"Quemalli","sequence":"additional","affiliation":[{"name":"Helios Klinikum Schwerin , Schwerin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1259-2379","authenticated-orcid":false,"given":"Robert","family":"Siegel","sequence":"additional","affiliation":[{"name":"Helios Klinikum Berlin-Buch , Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubert","family":"Zirngibl","sequence":"additional","affiliation":[{"name":"Helios Klinikum Wuppertal, Department of Surgery II, University of Witten\/Herdecke , Wuppertal, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0141-1747","authenticated-orcid":false,"given":"Rolf","family":"Lefering","sequence":"additional","affiliation":[{"name":"Institute for Research in Operative Medicine (IFOM), University of Witten\/Herdecke , Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"B\u00f6nicke","sequence":"additional","affiliation":[{"name":"Helios Klinikum Wuppertal, Department of Surgery II, University of Witten\/Herdecke , Wuppertal, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,5,27]]},"reference":[{"key":"2023020212562861500_zrac070-B1","doi-asserted-by":"crossref","first-page":"188","DOI":"10.1186\/s13063-019-3280-0","article-title":"Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial","volume":"20","author":"Langenbach","year":"2019","journal-title":"Trials"},{"key":"2023020212562861500_zrac070-B2","doi-asserted-by":"crossref","first-page":"215","DOI":"10.1007\/s00384-011-1316-3","article-title":"The prevalence of hemorrhoids in adults","volume":"27","author":"Riss","year":"2012","journal-title":"Int J Colorectal Dis"},{"key":"2023020212562861500_zrac070-B3","doi-asserted-by":"crossref","first-page":"e0139100","DOI":"10.1371\/journal.pone.0139100","article-title":"Risk factors for hemorrhoids on screening colonoscopy","volume":"10","author":"Peery","year":"2015","journal-title":"PLoS ONE"},{"key":"2023020212562861500_zrac070-B4","doi-asserted-by":"crossref","first-page":"2041","DOI":"10.1007\/s00384-021-03953-3","article-title":"An update on surgical treatment of hemorrhoidal disease: a systematic review and meta-analysis","volume":"36","author":"Aibuedefe","year":"2021","journal-title":"Int J Colorectal Dis"},{"key":"2023020212562861500_zrac070-B5","doi-asserted-by":"crossref","first-page":"650","DOI":"10.1111\/codi.14975","article-title":"European Society of ColoProctology: guideline for haemorrhoidal disease","volume":"22","author":"van Tol","year":"2020","journal-title":"Colorectal Dis"},{"key":"2023020212562861500_zrac070-B6","doi-asserted-by":"crossref","first-page":"944","DOI":"10.1056\/NEJMcp1204188","article-title":"Clinical practice. Hemorrhoids","volume":"371","author":"Jacobs","year":"2014","journal-title":"N Engl J Med"},{"key":"2023020212562861500_zrac070-B7","doi-asserted-by":"crossref","first-page":"1439","DOI":"10.1007\/s00384-013-1729-2","article-title":"Efficacy and safety of sclerotherapy with polidocanol foam in comparison with fluid sclerosant in the treatment of first-grade haemorrhoidal disease: a randomised, controlled, single-blind, multicentre trial","volume":"28","author":"Moser","year":"2013","journal-title":"Int J Colorectal Dis"},{"key":"2023020212562861500_zrac070-B8","doi-asserted-by":"crossref","first-page":"743","DOI":"10.1007\/BF02048364","article-title":"Outcome of delayed hemorrhage following surgical hemorrhoidectomy","volume":"36","author":"Rosen","year":"1993","journal-title":"Dis Colon Rectum"},{"key":"2023020212562861500_zrac070-B9","doi-asserted-by":"crossref","first-page":"1119","DOI":"10.1016\/S0140-6736(00)88465-2","article-title":"Surgical anatomy of the anal canal, and the operative treatment of haemorrhoids","volume":"2","author":"Milligan","year":"1937","journal-title":"Lancet"},{"key":"2023020212562861500_zrac070-B10","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1007\/s00384-018-3019-5","article-title":"A national evaluation of the management practices of hemorrhoidal disease in the Netherlands","volume":"33","author":"van Tol","year":"2018","journal-title":"Int J Colorectal Dis"},{"key":"2023020212562861500_zrac070-B11","doi-asserted-by":"crossref","first-page":"1509","DOI":"10.1007\/s00268-016-3419-z","article-title":"Milligan-Morgan (open) versus Ferguson haemorrhoidectomy (closed): a systematic review and meta-analysis of published randomized, controlled trials","volume":"40","author":"Bhatti","year":"2016","journal-title":"World J Surg"},{"key":"2023020212562861500_zrac070-B12","doi-asserted-by":"crossref","first-page":"687","DOI":"10.1007\/BF02048023","article-title":"Comparison of hemorrhoidal treatment modalities: a meta-analysis","volume":"38","author":"MacRae","year":"1995","journal-title":"Dis Colon Rectum"},{"key":"2023020212562861500_zrac070-B13","doi-asserted-by":"crossref","first-page":"335","DOI":"10.1007\/s00384-008-0611-0","article-title":"Stapled haemorrhoidopexy compared to Milligan\u2013Morgan and Ferguson haemorrhoidectomy: a systematic review","volume":"24","author":"Laughlan","year":"2009","journal-title":"Int J Colorectal Dis"},{"key":"2023020212562861500_zrac070-B14","first-page":"CD005393","article-title":"Stapled versus conventional surgery for hemorrhoids","volume":"2006","author":"Jayaraman","year":"2006","journal-title":"Cochrane Database Syst Rev"},{"key":"2023020212562861500_zrac070-B15","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1046\/j.1463-1318.2001.00189.x","article-title":"Evidence-based practice in haemorrhoidectomy","volume":"3","author":"Cheetham","year":"2001","journal-title":"Colorectal Dis"},{"key":"2023020212562861500_zrac070-B16","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/j.gcb.2010.10.001","article-title":"Prospective survey of secondary bleeding following anorectal surgery in a consecutive series of 1269 patients","volume":"35","author":"Pigot","year":"2011","journal-title":"Clin Res Hepatol Gastroenterol"},{"key":"2023020212562861500_zrac070-B17","doi-asserted-by":"crossref","first-page":"719","DOI":"10.1111\/codi.12090","article-title":"One-year outcome of haemorrhoidectomy: a prospective multicentre French study","volume":"15","author":"Bouchard","year":"2013","journal-title":"Colorectal Dis"},{"key":"2023020212562861500_zrac070-B18","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1007\/s10350-003-0129-z","article-title":"Topical metronidazole (10 percent) decreases posthemorrhoidectomy pain and improves healing","volume":"47","author":"Nicholson","year":"2004","journal-title":"Dis Colon Rectum"},{"key":"2023020212562861500_zrac070-B19","doi-asserted-by":"crossref","first-page":"1096","DOI":"10.1007\/s10350-004-6366-y","article-title":"Risk factors associated with posthemorrhoidectomy secondary hemorrhage: a single-institution prospective study of 4880 consecutive closed hemorrhoidectomies","volume":"45","author":"Chen","year":"2002","journal-title":"Dis Colon Rectum"},{"key":"2023020212562861500_zrac070-B20","doi-asserted-by":"crossref","first-page":"477","DOI":"10.1007\/BF02049406","article-title":"Symptomatic hemorrhoids: current incidence and complications of operative therapy","volume":"35","author":"Bleday","year":"1992","journal-title":"Dis Colon Rectum"},{"key":"2023020212562861500_zrac070-B21","doi-asserted-by":"crossref","first-page":"1385","DOI":"10.1002\/bjs.1800810948","article-title":"Simple non-adherent dressing versus gelatin foam sponge plug after haemorrhoidectomy: a prospective randomized trial","volume":"81","author":"Myles","year":"1994","journal-title":"Br J Surg"},{"key":"2023020212562861500_zrac070-B22","first-page":"308","article-title":"A prospective randomized study of calcium alginate (Sorbsan) versus standard gauze packing following haemorrhoidectomy","volume":"43","author":"Ingram","year":"1998","journal-title":"J R Coll Surg Edinb"},{"key":"2023020212562861500_zrac070-B23","doi-asserted-by":"crossref","first-page":"395","DOI":"10.1007\/s00384-013-1800-z","article-title":"Tamponade dressings may be unnecessary after haemorrhoidectomy: a randomised controlled clinical trial","volume":"29","author":"Langenbach","year":"2014","journal-title":"Int J Colorectal Dis"},{"key":"2023020212562861500_zrac070-B24","first-page":"13","author":"Claes","year":"1999","journal-title":"EuroQol Plenary Meeting, 1\u20132 October 1998. Discussion Papers"},{"key":"2023020212562861500_zrac070-B25","volume-title":"Der K\u00f6lner Patientenfragebogen (KPF): Entwicklung und Validierung eines Fragebogens zur Erfassung der Einbindung des Patienten als Kotherapeuten","author":"Pfaff","year":"2003"},{"key":"2023020212562861500_zrac070-B26","doi-asserted-by":"crossref","first-page":"693","DOI":"10.1002\/sim.5974","article-title":"Advanced multiplicity adjustment methods in clinical trials","volume":"33","author":"Alosh","year":"2014","journal-title":"Stat Med"},{"key":"2023020212562861500_zrac070-B27","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1007\/s00384-018-3176-6","article-title":"Risk of delayed bleeding after hemorrhoidectomy","volume":"34","author":"Ko-Chao","year":"2019","journal-title":"Int J Colorectal Dis"},{"key":"2023020212562861500_zrac070-B28","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1055\/s-0035-1568145","article-title":"Complications following anorectal surgery","volume":"29","author":"Kunitake","year":"2016","journal-title":"Clin Colon Rectal Surg"},{"key":"2023020212562861500_zrac070-B29","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1093\/bja\/aew466","article-title":"Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state","volume":"118","author":"Myles","year":"2017","journal-title":"Br J Anaesth"},{"key":"2023020212562861500_zrac070-B30","doi-asserted-by":"crossref","first-page":"1641","DOI":"10.1016\/j.ajem.2019.158489","article-title":"How much change in pain score does really matter to patients?","volume":"38","author":"Bahreini","year":"2020","journal-title":"Am J Emerg Med"},{"key":"2023020212562861500_zrac070-B31","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1186\/s13063-021-05750-3","article-title":"Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial","volume":"22","author":"Xue","year":"2021","journal-title":"Trials"}],"container-title":["BJS Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/bjsopen\/article-pdf\/6\/3\/zrac070\/49056878\/zrac070.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjsopen\/article-pdf\/6\/3\/zrac070\/49056878\/zrac070.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,2]],"date-time":"2023-02-02T15:23:20Z","timestamp":1675351400000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/bjsopen\/article\/doi\/10.1093\/bjsopen\/zrac070\/6594076"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,2]]},"references-count":31,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,5,2]]}},"URL":"https:\/\/doi.org\/10.1093\/bjsopen\/zrac070","relation":{},"ISSN":["2474-9842"],"issn-type":[{"value":"2474-9842","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2022,6,1]]},"published":{"date-parts":[[2022,5,2]]},"article-number":"zrac070"}}