title: Similar early complication rate in simultaneous pancreas and kidney recipients on tacrolimus/mycophenolate mofetil versus tacrolimus/sirolimus immunosuppressive regimens.
abstract: BACKGROUND
  We compared the incidence of severe complications among 123 consecutive simultaneous pancreas and kidney (SPK) recipients randomized for treatment either with tacrolimus plus mycophenolate mofetil (MMF) or tacrolimus plus sirolimus during their initial postoperative hospital stay.
  
  
  METHODS
  Patients with type 1 diabetes mellitus (T1DM) and renal failure with no age limit who underwent SPK were randomly assigned to tacrolimus/sirolimus or tacrolimus/MMF immunosuppressive protocols. We analyzed the rate of adverse events that led to death, graft loss, operative revision, or prolonged hospital stay.
  
  
  RESULTS
  From 2002 to 2009, 62 recipients were included in the MMF and 61 in the Rapamycin (Rapa) groups. More than 2/3 of recipients suffered from at least 1 complication: 74% MMF and 77 % Rapa group (P > .05). No patient died in the MMF and 3 in the Rapa group (P = .11). Pancreas graftectomy was performed in 13% of the MMF group and in 5% of the Rapa group (P = .20). Ten of 62 recipients in the MMF and 13/61 in the Rapa group required operative treatment of wound infections (P = .49). There were no differences in the rates of gastrointestinal bleeding (11% and 8%), kidney lymphocele (6% and 5%), ileus (1.6% both), pancreatic leak (1.6% both), or ureteral leak (0 and 3%) between the groups.
  
  
  CONCLUSIONS
  We did not observe a difference in the rate of severe postoperative complications between groups. With the use of extraperitoneal placement of the pancreatic graft, fluid collections and wound infections remain the most frequent albeit curable postoperative complications.
authors.affiliation: Diabetes Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. pegi@ikem.cz
authors.forename: P
authors.initials: P
authors.lastname: Girman
authors.forename: K
authors.initials: K
authors.lastname: Lipar
authors.forename: R
authors.initials: R
authors.lastname: Koznarova
authors.forename: P
authors.initials: P
authors.lastname: Boucek
authors.forename: J
authors.initials: J
authors.lastname: Kriz
authors.forename: M
authors.initials: M
authors.lastname: Kocik
authors.forename: T
authors.initials: T
authors.lastname: Havrdova
authors.forename: M
authors.initials: M
authors.lastname: Adamec
authors.forename: F
authors.initials: F
authors.lastname: Saudek
mesh_terms: D001926:Brain Death; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D003928:Diabetic Nephropathies / Q000601:surgery; D006760:Hospitalization; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007676:Kidney Failure, Chronic / Q000601:surgery*; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000276:immunology; D007902:Length of Stay; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D016035:Pancreas Transplantation / Q000009:adverse effects* / Q000276:immunology; D011183:Postoperative Complications / Q000453:epidemiology*; D020123:Sirolimus / Q000009:adverse effects*; D016559:Tacrolimus / Q000009:adverse effects*; D014019:Tissue Donors
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus