title: Identification of clinical outcome measures for recovery of gastrointestinal motility in postoperative ileus.
abstract: OBJECTIVE
  To identify clinical hallmarks associated with recovery of gastrointestinal transit.
  
  
  BACKGROUND
  Impaired gastrointestinal transit or postoperative ileus largely determines clinical recovery after abdominal surgery. However, validated clinical hallmarks of gastrointestinal recovery to evaluate new treatments and readiness for discharge from the hospital are lacking.
  
  
  METHODS
  Gastric emptying and colonic transit were scintigraphically assessed from postoperative day 1 to 3 in 84 patients requiring elective colonic surgery and were compared with clinical parameters. The clinical hallmark that best reflected recovery of gastrointestinal transit was validated using data from a multicenter trial of 320 segmental colectomy patients.
  
  
  RESULTS
  Seven of 84 patients developed a major complication with paralytic ileus characterized by total inhibition of gastrointestinal motility and were excluded from further analysis. In the remaining patients, recovery of colonic transit (defined as geometric center of radioactivity ≥2 on day 3), but not gastric emptying, was significantly correlated with clinical recovery (ρ = -0.59, P < 0.001). Conversely, the combined outcome measure of tolerance of solid food and having had defecation (SF + D) (area under the curve = 0.9, SE = 0.04, 95% CI = 0.79-0.95, P < 0.001), but not time to first flatus, best indicated recovery of gastrointestinal transit with a positive predictive value of 93% (95% CI = 78-99). Also in the main clinical trial, multiple regression analysis revealed that SF + D best predicted the duration of hospital stay.
  
  
  CONCLUSIONS
  Our data indicate that the time to SF + D best reflects recovery of gastrointestinal transit and therefore should be considered as primary outcome measure in future clinical trials on postoperative ileus.(Netherlands National Trial Register, number NTR1884 and NTR222).
authors: Departments of *Gastroenterology †Surgery ‡Anesthesiology §Clinical Epidemiology and Biostatistics ¶Nuclear Medicine, Academic Medical Center, Amsterdam, the Netherlands ‖Department of Gastroenterology, University Hospital Leuven, Catholic University of Leuven, Leuven, Belgium.
authors: Sjoerd H W
authors: SH
authors: van Bree
authors: Willem A
authors: WA
authors: Bemelman
authors: Markus W
authors: MW
authors: Hollmann
authors: Aeilko H
authors: AH
authors: Zwinderman
authors: Gianluca
authors: G
authors: Matteoli
authors: Shaima
authors: S
authors: El Temna
authors: Frans O
authors: FO
authors: The
authors: Malaika S
authors: MS
authors: Vlug
authors: Roelof J
authors: RJ
authors: Bennink
authors: Guy E E
authors: GE
authors: Boeckxstaens
mesh_terms: D000368:Aged; D003082:Colectomy / Q000379:methods; D003106:Colon / Q000502:physiology / Q000601:surgery; D003110:Colonic Neoplasms / Q000601:surgery; D003672:Defecation; D004435:Eating; D017558:Elective Surgical Procedures; D005260:Female; D005746:Gastric Emptying; D005769:Gastrointestinal Motility; D005772:Gastrointestinal Transit; D006801:Humans; D045823:Ileus / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000209:etiology; D053208:Kaplan-Meier Estimate; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010351:Patient Discharge / Q000592:standards; D011183:Postoperative Complications / Q000175:diagnosis* / Q000000981:diagnostic imaging; D011184:Postoperative Period; D012372:ROC Curve; D011877:Radionuclide Imaging; D020127:Recovery of Function