Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial View Full Text


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Article Info

DATE

2019-12

AUTHORS

Mike Ralf Langenbach, Dörthe Seidel

ABSTRACT

BACKGROUND: Symptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades after open hemorrhoidectomy to manage postoperative bleeding. The question of whether a tamponade is necessary and beneficial after hemorrhoidectomy has not yet been conclusively answered. A previously conducted single-center pilot trial included 100 patients after Milligan-Morgan hemorrhoidectomy. The data indicated that insertion of an anal tamponade after hemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. The findings of this pilot trial are now to be verified by means of a multicenter randomized clinical study called NoTamp. METHODS: We plan to include 953 patients after Milligan-Morgan or Parks hemorrhoidectomy in the NoTamp study. The aim is to demonstrate that using no tamponade dressing after open hemorrhoidectomy is not inferior to using tamponades with respect to postoperative bleeding, and that the patients report less pain. Primary endpoints of the trial are the maximum postoperative pain within 48 h and the incidence of severe postoperative bleeding that requires surgical revision within 7 days after the surgical procedure. Secondary endpoints of the study are the use of analgesics in the postoperative course, the lowest hemoglobin documented within 7 days, quality of life and patient satisfaction. Safety analysis includes all adverse and serious adverse events in relation to the study treatment. Further information can be found in the registration at the German Registry of Clinical Studies (DRKS00011590) and on the study webpage ( https://notamp.de/en-GB/trial/main/setLocale/en_GB/ ). The study is financed by the HELIOS research funding. DISCUSSION: The study received full ethics committee approval. The first patient was enrolled on 3 May 2017. This trial will finally answer the question whether the insertion of a tamponade after open hemorrhoidectomy is necessary and beneficial. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien (DRKS), DRKS00011590 . Registered on 12 April 2017. More... »

PAGES

188

References to SciGraph publications

  • 2012-02. The prevalence of hemorrhoids in adults in INTERNATIONAL JOURNAL OF COLORECTAL DISEASE
  • 2004-02. Die konservative Hämorrhoidenbehandlung in WIENER MEDIZINISCHE WOCHENSCHRIFT
  • 1991-07. Temporal changes in the occurrence of hemorrhoids in the United States and England in DISEASES OF THE COLON & RECTUM
  • 2013-08. Stadiengerechte Therapie des Hämorrhoidalleidens in COLOPROCTOLOGY
  • 1985-08. Edward Thomas Campbell Milligan 1886–1972 in DISEASES OF THE COLON & RECTUM
  • 1995-07. Comparison of hemorrhoidal treatment modalities in DISEASES OF THE COLON & RECTUM
  • 1993-08. Outcome of delayed hemorrhage following surgical hemorrhoidectomy in DISEASES OF THE COLON & RECTUM
  • 1959-03. Closed hemorrhoidectomy in DISEASES OF THE COLON & RECTUM
  • 2009-03. Stapled haemorrhoidopexy compared to Milligan–Morgan and Ferguson haemorrhoidectomy: a systematic review in INTERNATIONAL JOURNAL OF COLORECTAL DISEASE
  • 2014-03. Tamponade dressings may be unnecessary after haemorrhoidectomy: a randomised controlled clinical trial in INTERNATIONAL JOURNAL OF COLORECTAL DISEASE
  • 2002-08. Risk Factors Associated With Posthemorrhoidectomy Secondary Hemorrhage in DISEASES OF THE COLON & RECTUM
  • 1992-05. Symptomatic hemorrhoids: Current incidence and complications of operative therapy in DISEASES OF THE COLON & RECTUM
  • 2004-05. Topical Metronidazole (10 Percent) Decreases Posthemorrhoidectomy Pain and Improves Healing in DISEASES OF THE COLON & RECTUM
  • Journal

    TITLE

    Trials

    ISSUE

    1

    VOLUME

    20

    Author Affiliations

    Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-019-3280-0

    DOI

    http://dx.doi.org/10.1186/s13063-019-3280-0

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1113179540

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30940201


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