title: Complications after end-to-end vs. side-to-side anastomosis in ileocecal Crohn's disease--early postoperative results from a randomized controlled multi-center trial (ISRCTN-45665492).
abstract: BACKGROUND
  Recurrent Crohn's disease activity at the site of anastomosis after ileocecal resection is of great surgical importance. This prospective randomized multi-center trial with an estimated case number of 224 patients was initially planned to investigate whether stapled side-to-side anastomosis, compared to hand-sewn end-to-end anastomosis, results in a decreased recurrence of Crohn's disease following ileocolic resection (primary endpoint). The secondary endpoint was to focus on the early postoperative results comparing both surgical methods. The study was terminated early due to insufficient patient recruitment and because another large study investigated the same question, while our trial was ongoing.
  
  
  METHODS
  Patients with stenosing ileitis terminalis in Crohn's disease who underwent an ileocolic resection were randomized to side-to-side or end-to-end anastomosis. Due to its early discontinuation, our study only investigated the secondary endpoints, the early postoperative results (complications: bleeding, wound infection, anastomotic leakage, first postoperative stool, duration of hospital stay).
  
  
  RESULTS
  From February 2006 until June 2010, 67 patients were enrolled in nine participating centers. The two treatment groups were comparable to their demographic and pre-operative data. BMI and Crohn's Disease Activity Index were 22.2 (± 4.47) and 200.5 (± 73.66), respectively, in the side-to-side group compared with 23.3 (± 4.99) and 219.6 (± 89.03) in the end-to-end group. The duration of surgery was 126.7 (± 42.8) min in the side-to-side anastomosis group and 137.4 (± 51.9) min in the end-to-end anastomosis group. Two patients in the end-to-end anastomosis group developed an anastomotic leakage (6.5%). Impaired wound healing was found in 13.9% of the side-to-side anastomosis group, while 6.5% of the end-to-end anastomosis group developed this complication. The duration of hospital stay was comparable in both groups with 9.9 (± 3.93) and 10.4 (± 3.26) days, respectively.
  
  
  CONCLUSIONS
  Because of the early discontinuation of the study, it is not possible to provide a statement about the perianastomotic recurrence rates regarding the primary endpoint. With regard to the early postoperative outcome, we observed no difference between the two types of anastomosis.
authors.affiliation: Department of General, Vascular and Thoracic Surgery, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.urte.zurbuchen@charite.de
authors.forename: Urte
authors.initials: U
authors.lastname: Zurbuchen
authors.forename: Anton J
authors.initials: AJ
authors.lastname: Kroesen
authors.forename: Philipp
authors.initials: P
authors.lastname: Knebel
authors.forename: Michael-Hans
authors.initials: MH
authors.lastname: Betzler
authors.forename: Heinz
authors.initials: H
authors.lastname: Becker
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Bruch
authors.forename: Norbert
authors.initials: N
authors.lastname: Senninger
authors.forename: Stefan
authors.initials: S
authors.lastname: Post
authors.forename: Heinz J
authors.initials: HJ
authors.lastname: Buhr
authors.forename: Jörg-Peter
authors.initials: JP
authors.lastname: Ritz
mesh_terms: D000328:Adult; D000714:Anastomosis, Surgical / Q000009:adverse effects / Q000379:methods; D057868:Anastomotic Leak / Q000175:diagnosis* / Q000453:epidemiology; D003082:Colectomy / Q000379:methods; D003106:Colon / Q000601:surgery*; D003424:Crohn Disease / Q000175:diagnosis* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007082:Ileum / Q000601:surgery*; D015994:Incidence; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D019106:Postoperative Hemorrhage / Q000175:diagnosis* / Q000453:epidemiology; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult