title: Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial.
abstract: OBJECTIVE
  Adhesions are the most common cause of small bowel obstruction (SBO). The costs of hospitalization and surgery for SBO are substantial for the health-care system. The adhesion-limiting potential of icodextrin has been shown in patients undergoing surgery for gynaecological diseases. A randomized, multicentre trial in colorectal cancer surgery started in 2009 with the aim of evaluating whether icodextrin could reduce the long-term risk of surgery for SBO. Because of some concerns about complications (especially anastomotic leakage) after icodextrin use, a preplanned interim analysis of morbidity and mortality was conducted.
  
  
  METHODS
  Patients with colorectal cancer without metastasis were randomized 1:1 to receive standard surgery, with or without instillation of icodextrin in the abdominal cavity. For the first 300 patients, the 30-day follow-up data were collected from the Swedish ColoRectal Cancer Registry (SCRCR). Pre-, per- and postoperative data, morbidity and mortality were analysed.
  
  
  RESULTS
  Of the 300 randomized patients, 288 had a data file in the SCRCR. Twelve patients did not have cancer and another five did not have a resection, leaving 283 for analysis. The authors were blinded to the randomization groups. Demographic data were similar in both groups. The overall complication rate was 24% in Group 1 and 23% in Group 2 (P = 0.89). Four cases of anastomotic leakage were reported in Group 1 and five were reported in Group 2 (P = 1.0). Mortality, intensive care unit (ICU) stay and re-operations did not differ between the groups.
  
  
  CONCLUSIONS
  The pre-planned safety analysis of the first 300 patients enrolled in this randomized trial did not show any differences in adverse effects related to the use of icodextrin. All data were gathered from the SCRCR, giving us a strong message that we can continue to include patients in the trial.
authors.affiliation: Department of Surgery, Gävle Hospital and Centre for Research and Development, Uppsala University/Count Council of Gävleborg, Gävleborg, Sweden.
authors.forename: T
authors.initials: T
authors.lastname: Sakari
authors.affiliation: Department of Surgery, University Hospital Linköping, Linköping, Sweden.
authors.forename: R
authors.initials: R
authors.lastname: Sjödahl
authors.affiliation: Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: L
authors.initials: L
authors.lastname: Påhlman
authors.affiliation: Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: U
authors.initials: U
authors.lastname: Karlbom
mesh_terms: D034841:Abdominal Cavity / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms / Q000601:surgery; D015314:Dialysis Solutions / Q000008:administration & dosage; D013505:Digestive System Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D005260:Female; D005936:Glucans / Q000008:administration & dosage*; D005947:Glucose / Q000008:administration & dosage*; D006801:Humans; D000077607:Icodextrin; D007415:Intestinal Obstruction / Q000209:etiology / Q000517:prevention & control*; D007421:Intestine, Small / Q000601:surgery; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011183:Postoperative Complications; D013548:Sweden; D000267:Tissue Adhesions / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D015314:Dialysis Solutions; D005936:Glucans; D000077607:Icodextrin; D005947:Glucose
keywords: Adhesions; colorectal cancer; complications; small bowel obstruction