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Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial
Uppsala University, Sweden.
Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
Uppsala University, Sweden.
Uppsala University, Sweden.
2016 (English)In: Colorectal Disease, ISSN 1462-8910, E-ISSN 1463-1318, Vol. 18, no 3, 295-300 p.Article in journal (Refereed) PublishedText
Abstract [en]

AimAdhesions 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. MethodPatients 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. ResultsOf 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. ConclusionThe 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.

Place, publisher, year, edition, pages
WILEY-BLACKWELL , 2016. Vol. 18, no 3, 295-300 p.
Keyword [en]
Adhesions; small bowel obstruction; complications; colorectal cancer
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:liu:diva-127051DOI: 10.1111/codi.13095ISI: 000372036000014PubMedID: 26934850OAI: oai:DiVA.org:liu-127051DiVA: diva2:919392
Note

Funding Agencies|Makarna Edvin Erikssons Foundation; Swedish Cancer Foundation; ALF grants in Uppsala University

Available from: 2016-04-13 Created: 2016-04-13 Last updated: 2016-04-13

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Sjödahl, Rune
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Division of Clinical SciencesFaculty of Medicine and Health SciencesDepartment of Surgery in Linköping
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