Comparative Study of Circular Stapling Instruments
Summary
After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Anastomotic Leak
Intervention
AutoSuture Premium Plus CEEA/Ethicon Proximate ILS
Location
Uppsala University Hospital
Uppsala
Sweden
751 85
Status
Terminated
Source
Uppsala University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00399009
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Anastomotic Leak
Breakdown of the connection and subsequent leakage of digestive system fluid from a SURGICAL ANASTOMOSIS of digestive system structures. Most common leakages are from breakdown of the sutured lines in gastrointestinal or bowel anastomosis.
Capillary Leak Syndrome
A condition characterized by recurring episodes of fluid leaking from capillaries into extra-vascular compartments causing hematocrit to rise precipitously. If not treated, generalized vascular leak can lead to generalized EDEMA; SHOCK; cardiovascular collapse; and MULTIPLE ORGAN FAILURE.
Prepaid Health Plans
Contracts between an insurer and a subscriber or a group of subscribers whereby a specified set of health benefits is provided in return for a periodic premium.
Postgastrectomy Syndromes
Sequelae of gastrectomy from the second week after operation on. Include recurrent or anastomotic ulcer, postprandial syndromes (DUMPING SYNDROME and late postprandial hypoglycemia), disordered bowel action, and nutritional deficiencies.
Health Benefit Plans, Employee
Health insurance plans for employees, and generally including their dependents, usually on a cost-sharing basis with the employer paying a percentage of the premium.
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