title: Development and clinical implementation of a hemostatic balloon device for rectal cancer surgery.
abstract: BACKGROUND
  Surgery for locally advanced and recurrent rectal carcinoma can be associated with major blood loss.
  
  
  OBJECTIVE
  We developed a promising technique using a hemostatic balloon to stop uncontrollable bleeding.
  
  
  METHODS
  Models were developed using pelvic magnetic resonance imaging scans, and these models were tested in a cadaveric study. Eventually a model was tested in a clinical setting. The Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred.
  
  
  METHODS
  A tertiary referral hospital for locally advanced and recurrent rectal cancer.
  
  
  METHODS
  Patients receiving multimodality treatment for primary or recurrent locally advanced rectal carcinomas.
  
  
  METHODS
  First the developed prototypes were tested in a cadaveric study where the developing pressure on the pelvic wall was measured. Second, the Hemostatic Balloon Device was placed in patients in whom during surgery uncontrollable bleeding from the venous presacral plexus occurred.
  
  
  RESULTS
  The balloon was used in 9 patients. Median volume of blood loss was 7500 mL. In 8 patients treatment with the hemostatic balloon was successful. In 1 patient the balloon was dislocated cranially and the pelvis was packed with surgical gauzes.
  
  
  CONCLUSIONS
  These first results are promising but further research is needed to evaluate how effective the balloon is in controlling massive bleeding during rectal cancer surgery. Future perspectives include a possibly thinner silicon rubber that can be stretched more easily with a lower inflated volume.
  
  
  CONCLUSIONS
  The hemostatic balloon is a new and promising technique for accomplishing hemostasis with controllable pressure on the pelvic cavity wall and can be removed without the need for a second laparotomy.
authors.affiliation: St Elisabeth Hospital, Tilburg, Netherlands.
authors.forename: Fabian A
authors.initials: FA
authors.lastname: Holman
authors.affiliation: Delft University of Technology, Delft, Netherlands.
authors.forename: Noortje
authors.initials: N
authors.lastname: van der Pant
authors.affiliation: Catharina Hospital, Eindhoven, Netherlands.
authors.forename: Ignace H J T
authors.initials: IH
authors.lastname: de Hingh
authors.affiliation: Catharina Hospital, Eindhoven, Netherlands.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Martijnse
authors.affiliation: Catharina Hospital, Eindhoven, Netherlands.
authors.forename: Jack
authors.initials: J
authors.lastname: Jakimowicz
authors.affiliation: Catharina Hospital, Eindhoven, Netherlands Harm.Rutten@cze.nl.
authors.forename: Harm J
authors.initials: HJ
authors.lastname: Rutten
authors.affiliation: Delft University of Technology, Delft, Netherlands Erasmus Medical Center, Rotterdam, Netherlands.
authors.forename: Richard H M
authors.initials: RH
authors.lastname: Goossens
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control; D015331:Cohort Studies; D004867:Equipment Design; D005260:Female; D006488:Hemostasis, Surgical / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D059351:Organ Sparing Treatments; D012004:Rectal Neoplasms / Q000601:surgery*
keywords: colorectal surgery; surgical education; surgical oncology