title: Laparoscopic versus conventional ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy (LapConPouch Trial)-a randomized controlled trial.
abstract: OBJECTIVE
  Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the standard surgical procedure for ulcerative colitis (UC) and familial adenomatous polyposis (FAP). While minimal invasive techniques have been applied increasingly, clear evidence of superiority for laparoscopic pouch procedures is not yet available. The aim of the LapConPouch Trial was to compare the effectiveness of laparoscopic (LAP) versus conventional (CON) ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy.
  
  
  METHODS
  The trial was designed as a single-centre, pre-operatively randomized, controlled trial using a two-group parallel superiority design. Eligible for participation were patients scheduled for restorative proctocolectomy either for FAP or for UC. Patients and outcome assessors were blinded to group assignment. The primary endpoint was defined as the amount of blood loss. Statistical analyses were explorative since the trial had to be stopped prematurely.
  
  
  RESULTS
  A total of 42 patients (21 LAP (50.0 %); 21 CON (50.0 %)) were randomized. The trial had to be stopped prematurely due to insufficient patient recruitment. There was no difference in the amount of blood loss between both groups: LAP 261.5 ± 195.4 ml, CON 228.1 ± 119.5 ml. Secondary endpoints differ in both groups. Laparoscopic surgery was superior regarding the length of skin incision; in contrast, the conventional approach was superior in duration of operation. There were no discrepancies in length of hospital stay, postoperative pain, bowel function, and quality of life between both approaches. The conversion rate from LAP to CON approach was 23.8 %.
  
  
  CONCLUSIONS
  There was no difference with respect to blood loss between the LAP and the CON group. The LAP approach is feasible for restorative proctocolectomy, and IPAA seems at least as safe as CON surgery. The most obvious advantage of the minimal invasive technique is the improved cosmesis.
authors.affiliation: Department of General, Visceral and Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.
authors.forename: Serin
authors.initials: S
authors.lastname: Schiessling
authors.forename: Christine
authors.initials: C
authors.lastname: Leowardi
authors.forename: Peter
authors.initials: P
authors.lastname: Kienle
authors.forename: Dalibor
authors.initials: D
authors.lastname: Antolovic
authors.forename: Phillip
authors.initials: P
authors.lastname: Knebel
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.forename: Martina
authors.initials: M
authors.lastname: Kadmon
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Seiler
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.forename: Alexis
authors.initials: A
authors.lastname: Ulrich
mesh_terms: D011125:Adenomatous Polyposis Coli / Q000175:diagnosis / Q000601:surgery; D000328:Adult; D016063:Blood Loss, Surgical; D016009:Chi-Square Distribution; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000601:surgery; D039021:Colonic Pouches; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D007813:Laparotomy / Q000009:adverse effects / Q000379:methods*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D018579:Patient Selection; D011183:Postoperative Complications / Q000503:physiopathology / Q000601:surgery; D016737:Proctocolectomy, Restorative / Q000009:adverse effects / Q000379:methods*; D011379:Prognosis; D011788:Quality of Life; D018570:Risk Assessment; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D055815:Young Adult