Change search
ReferencesLink to record
Permanent link

Direct link
Randomised multicentre trial of circular stapling devices
Department of Surgery, Uppsala University Hospital, 751 85, Uppsala, Sweden .
Sheffield Teaching Hospitals, Sheffield, UK .
Centre of Surgical Gastroenterology, Karolinska University Hospital, Huddinge and Karolinska Institute, Stockholm, Sweden.
Department of Surgery, Uppsala University Hospital, 751 85, Uppsala, Sweden .
2012 (English)In: International Journal of Colorectal Disease, ISSN 0179-1958, E-ISSN 1432-1262, Vol. 27, no 2, 227-232 p.Article in journal (Refereed) Published
Abstract [en]

PURPOSE: In a register study, the risk of anastomotic leakage correlated to the choice of circular stapling device with a 4% difference between the two brands used. Based on those data, a randomised multicentre study was started to explore the risk of an anastomotic leakage based upon the surgical device.

METHODS: Patients above 18 years with a rectal cancer, able to give informed consent, and scheduled for an anterior resection were eligible for the study. Perioperative randomisation was to Ethicon™ PROXIMATE™ ILS™ or Autosuture™ Premium Plus CEEA™. Anastomotic leakage was defined as a clinically manifest leak.

RESULTS: Five hundred twenty-nine patients were randomised (58% male). A leak occurred in 8.3%. The anastomoses created by PROXIMATE™ ILS™ leaked in 25/265 (9.4%) anastomoses, and the Premium Plus CEEA™ leaked in 19/260 (7.3%), p = .419.

CONCLUSION: No difference in the leak rate could be revealed. Several centres replaced one of the staplers by a new product, and the study was ended before the stipulated number of patients was reached. In the future, surgical devices may have to prove superiority in randomised trials or be monitored in quality registers before they can be introduced into day to day surgical practice. The study was registered at NCT00399009.

Place, publisher, year, edition, pages
Springer, 2012. Vol. 27, no 2, 227-232 p.
National Category
URN: urn:nbn:se:umu:diva-83423DOI: 10.1007/s00384-011-1307-4PubMedID: 21909698OAI: diva2:667105
Available from: 2013-11-25 Created: 2013-11-25 Last updated: 2014-08-14

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Gunnarsson, Ulf
In the same journal
International Journal of Colorectal Disease

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 15 hits
ReferencesLink to record
Permanent link

Direct link