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HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): Results of a Multicenter Randomized Trial (DRKS00000040)

Löffler, Thorsten*,†; Rossion, Inga; Bruckner, Thomas; Diener, Markus K.*,†; Koch, Moritz*; von Frankenberg, Moritz; Pochhammer, Julius; Thomusch, Oliver#; Kijak, Thomas**; Simon, Thomas††; Mihaljevic, André L.‡‡; Krüger, Matthias§§; Stein, Erwin‖‖; Prechtl, Gerald¶¶; Hodina, René##; Michal, Walter***; Strunk, Roland†††; Henkel, Karl‡‡‡; Bunse, Jörg§§§; Jaschke, Gregor‖‖‖; Politt, Dirk¶¶¶; Heistermann, Hans Peter###; Fuer, Mathis****ß; Lange, Claas††††; Stamm, Achim‡‡‡‡; Vosschulte, Andreas§§§§; Holzer, Ralf‖‖‖‖; Partecke, Lars Ivo¶¶¶¶; Burdzik, Emanuel####; Hug, Hubert M.*****; Luntz, Steffen P.§; Kieser, Meinhard; Büchler, Markus W.*,†; Weitz, Jürgen MD*; the HASTA Trial Group

Annals of Surgery:
doi: 10.1097/SLA.0b013e318272df97
Original Articles From the ESA Proceedings
Abstract

Objectives: The objective of the HASTA trial was to compare hand suture versus stapling loop ileostomy closure in a randomized controlled trial.

Background: Bowel 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.

Methods: HASTA 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.

Results: A 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.

Conclusions: Hand-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.

In Brief

The objective of the HASTA trial was to compare hand suture versus stapling loop ileostomy closure in a randomized controlled trial in 334 patients with the primary endpoint bowel obstruction. The overall rate of postoperative ileus after ileostomy closure was 12% with no difference between groups.

Author Information

*Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany

Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany

Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

§Coordination Centre for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany

Department of General, Visceral and Minimal Invasive Surgery, Salem Hospital, Heidelberg, Germany

Marien Hospital, Stuttgart, Germany

#Department of General and Visceral Surgery, University of Freiburg, Freiburg, Germany

**Department of General and Visceral Surgery, Robert Bosch Hospital, Stuttgart, Germany

††Department of General and Visceral Surgery, GRN-Klinik Sinsheim, Germany

‡‡Department of General Surgery, Technische Universität München and CHIR-Net Munich, Germany

§§Department of General, Visceral and Vascular Surgery, Klinikum Magdeburg gGmbH, Germany

‖‖Department of Surgery, St.-Josefs Hospital, Dortmund, Germany

¶¶Department of Surgery, Klinikum Landkreis Neumarkt in der Oberpfalz, Germany

##Department of General, Visceral and Thoracic Surgery, Klinik am Steinenberg, Reutlingen, Germany

***Department of Surgery, Krankenhaus St. Marienwörth, Bad Kreuznach, Germany

†††Department of Surgery, St. Marien Krankenhaus Siegen gGmbH, Germany

‡‡‡Department of Surgery, Romed Klinik Prien am Chiemsee, Germany

§§§Department of General and Visceral Surgery, Sana Klinikum Lichtenberg, Berlin, Germany;

‖‖‖Department of General and Visceral Surgery, Krankenhaus Porz am Rhein gGmbH, Köln, Germany

¶¶¶Department of General, Visceral, Vascular, and Thoracic Surgery, Kreiskrankenhaus Gummersbach, Germany

###Department of General and Visceral Surgery, Heilig Geist-Krankenhaus, Köln, Germany

****Department of General and Visceral Surgery, Diakonissen-Stiftungs-Krankenhaus Speyer, Germany

††††Department of Surgery, Schlosspark Klinik Berlin, Germany

‡‡‡‡Department of General and Visceral Surgery, Caritas Krankenhaus Dillingen, Germany

§§§§Department of General Surgery, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany

‖‖‖‖Department of General, Visceral and Thoracic Surgery, Klinikum Rosenheim, Germany

¶¶¶¶Department of General, Visceral, Thoracic and Vascular Surgery, Universitätsklinikum Greifswald, Germany

####Department of General and Visceral Surgery, St. Josefs-Hospital, Bochum-Linden, Germany

*****Department of General and Visceral Surgery, Kliniken Landkreis Sigmaringen GmbH, Germany.

Reprints: Jürgen Weitz, MD, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. E-mail: juergen.weitz@med.uni-heidelberg.de.

Disclosure: The Study Center of the German Surgical Society is supported by a grant from the German Ministry of Education and Research [Bundesministerium für Bildung und Forschung (BMBF); 01GH0702] and the German Surgical Society [Deutsche Gesellschaft für Chirurgie (DGCH)]. Additional industrial funding for the infrastructure has been provided by Covidien Healthcare Deutschland GmbH, Neustadt, Germany. The trial itself is supported by a grant from Johnson & Johnson Medical GmbH, Norderstedt, Germany. Sponsor had no role regarding data acquisition, analysis, or interpretation. There are no restrictions on publications. There is no conflict of interest. Industrial funders and trial management are independent.

© 2012 Lippincott Williams & Wilkins, Inc.