title: Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial.
abstract: BACKGROUND
  Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet.
  
  
  METHODS
  A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer.The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol.
  
  
  CONCLUSIONS
  Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer.
  
  
  BACKGROUND
  German Clinical Trial Register Number: DRKS00000040.
authors.affiliation: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Löffler
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Seiler
authors.forename: Inga
authors.initials: I
authors.lastname: Rossion
authors.forename: Thomas
authors.initials: T
authors.lastname: Kijak
authors.forename: Oliver
authors.initials: O
authors.lastname: Thomusch
authors.forename: Renè
authors.initials: R
authors.lastname: Hodina
authors.forename: Matthias
authors.initials: M
authors.lastname: Krüger
authors.forename: Thomas
authors.initials: T
authors.lastname: Simon
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
authors.forename: Jürgen
authors.initials: J
authors.lastname: Weitz
mesh_terms: D005858:Germany; D006761:Hospitals; D006801:Humans; D007081:Ileostomy; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000601:surgery*; D012107:Research Design; D017792:Surgical Stapling; D013536:Suture Techniques; D013997:Time Factors; D016896:Treatment Outcome