title: Risk factors to predict the incidence of surgical adverse events following open or laparoscopic surgery for apparent early stage endometrial cancer: results from a randomised controlled trial.
abstract: OBJECTIVE
  To identify risk factors for major adverse events (AEs) and to develop a nomogram to predict the probability of such AEs in patients who have surgery for apparent early stage endometrial cancer.
  
  
  METHODS
  We used data from 753 patients who were randomised to either total laparoscopic hysterectomy or total abdominal hysterectomy in the LACE trial. Serious adverse events that prolonged hospital stay or postoperative adverse events (using common terminology criteria 3+, CTCAE V3) were considered major AEs. We analysed pre-surgical characteristics that were associated with the risk of developing major AEs by multivariate logistic regression. We identified a parsimonious model by backward stepwise logistic regression. The six most significant or clinically important variables were included in the nomogram to predict the risk of major AEs within 6weeks of surgery and the nomogram was internally validated.
  
  
  RESULTS
  Overall, 132 (17.5%) patients had at least one major AE. An open surgical approach (laparotomy), higher Charlson's medical co-morbidities score, moderately differentiated tumours on curettings, higher baseline Eastern Cooperative Oncology Group (ECOG) score, higher body mass index and low haemoglobin levels were associated with AE and were used in the nomogram. The bootstrap corrected concordance index of the nomogram was 0.63 and it showed good calibration.
  
  
  CONCLUSIONS
  Six pre-surgical factors independently predicted the risk of major AEs. This research might form the basis to develop risk reduction strategies to minimise the risk of AEs among patients undergoing surgery for apparent early stage endometrial cancer.
authors.affiliation: University of Queensland, School of Medicine, QLD, Australia.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Kondalsamy-Chennakesavan
authors.forename: Monika
authors.initials: M
authors.lastname: Janda
authors.forename: Val
authors.initials: V
authors.lastname: Gebski
authors.forename: Jannah
authors.initials: J
authors.lastname: Baker
authors.forename: Alison
authors.initials: A
authors.lastname: Brand
authors.forename: Russell
authors.initials: R
authors.lastname: Hogg
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Jobling
authors.forename: Russell
authors.initials: R
authors.lastname: Land
authors.forename: Tom
authors.initials: T
authors.lastname: Manolitsas
authors.forename: Marcelo
authors.initials: M
authors.lastname: Nascimento
authors.forename: Deborah
authors.initials: D
authors.lastname: Neesham
authors.forename: James L
authors.initials: JL
authors.lastname: Nicklin
authors.forename: Martin K
authors.initials: MK
authors.lastname: Oehler
authors.forename: Geoff
authors.initials: G
authors.lastname: Otton
authors.forename: Lewis
authors.initials: L
authors.lastname: Perrin
authors.forename: Stuart
authors.initials: S
authors.lastname: Salfinger
authors.forename: Ian
authors.initials: I
authors.lastname: Hammond
authors.forename: Yee
authors.initials: Y
authors.lastname: Leung
authors.forename: Peter
authors.initials: P
authors.lastname: Sykes
authors.forename: Hextan
authors.initials: H
authors.lastname: Ngan
authors.forename: Andrea
authors.initials: A
authors.lastname: Garrett
authors.forename: Michael
authors.initials: M
authors.lastname: Laney
authors.forename: Tong Yow
authors.initials: TY
authors.lastname: Ng
authors.forename: Karfai
authors.initials: K
authors.lastname: Tam
authors.forename: Karen
authors.initials: K
authors.lastname: Chan
authors.forename: David H
authors.initials: DH
authors.lastname: Wrede
authors.forename: Selvan
authors.initials: S
authors.lastname: Pather
authors.forename: Bryony
authors.initials: B
authors.lastname: Simcock
authors.forename: Rhonda
authors.initials: R
authors.lastname: Farrell
authors.forename: Gregory
authors.initials: G
authors.lastname: Robertson
authors.forename: Graeme
authors.initials: G
authors.lastname: Walker
authors.forename: Anthony
authors.initials: A
authors.lastname: McCartney
authors.forename: Andreas
authors.initials: A
authors.lastname: Obermair
mesh_terms: D000465:Algorithms; D001315:Australia / Q000453:epidemiology; D003661:Decision Support Techniques; D016889:Endometrial Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects* / Q000379:methods; D015994:Incidence; D010535:Laparoscopy / Q000009:adverse effects*; D007902:Length of Stay; D016015:Logistic Models; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D049451:Nomograms; D016017:Odds Ratio; D011183:Postoperative Complications / Q000453:epidemiology* / Q000628:therapy; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome