• Annals of surgery · Nov 2012

    Randomized Controlled Trial Multicenter Study Comparative Study

    HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040).

    • Thorsten Löffler, Inga Rossion, Thomas Bruckner, Markus K Diener, Moritz Koch, Moritz von Frankenberg, Julius Pochhammer, Oliver Thomusch, Thomas Kijak, Thomas Simon, André L Mihaljevic, Matthias Krüger, Erwin Stein, Gerald Prechtl, René Hodina, Walter Michal, Roland Strunk, Karl Henkel, Jörg Bunse, Gregor Jaschke, Dirk Politt, Hans Peter Heistermann, Mathis Fußer, Claas Lange, Achim Stamm, Andreas Vosschulte, Ralf Holzer, Lars Ivo Partecke, Emanuel Burdzik, Hubert M Hug, Steffen P Luntz, Meinhard Kieser, Markus W Büchler, Jürgen Weitz, and HASTA Trial Group.
    • Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, Heidelberg, Germany.
    • Ann. Surg.. 2012 Nov 1;256(5):828-35; discussion 835-6.

    ObjectivesThe objective of the HASTA trial was to compare hand suture versus stapling loop ileostomy closure in a randomized controlled trial.BackgroundBowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy after low anterior resection. The best surgical technique for closure of loop ileostomy has not been defined yet.MethodsHASTA trial is a multicenter pragmatic randomized controlled surgical trial with 2 parallel groups to compare hand suture versus stapling for closure of loop ileostomy. The primary endpoint was the rate of bowel obstruction within 30 days after ileostomy closure.ResultsA total of 337 randomized patients undergoing closure of loop ileostomy after low anterior resection because of rectal cancer in 27 centers were included. The overall rate of postoperative ileus after ileostomy closure was 13.4%. Seventeen of 165 (10.3%) patients in the stapler group and 27 of 163 (16.6%) in the hand suture group developed bowel obstruction within 30 days postoperatively [odds ratio (OR) = 1.72; 95% confidence interval (CI): 0.89-3.31 = 0.10]. Duration of surgical intervention was significantly shorter in the stapler group (15 minutes; P < 0.001). Multivariable analysis of potential risk factors did not reveal any significant correlation with development of postoperative ileus. Rate of anastomotic leakage (stapler: 3.0%, hand suture: 1.8%, P = 0.48) did not differ significantly as well as all other secondary endpoints.ConclusionsHand-sewn anastomosis versus stapler ileo-ileostomy for ileostomy closure are equally effective in terms of postoperative bowel obstruction, with stapler anastomosis leading to a shorter operation time. Postoperative ileus after ileostomy reversal remains a relevant complication.

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