Status:
COMPLETED
Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Carponovum AB
Conditions:
Cancer
Polyp
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The intestinal ends must be rejoined after colonic resection. Conventional methods include sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic surgery. The leakage of ...
Eligibility Criteria
Inclusion
- Age between 18 - 90 years (male or female)
- Planned resection due to benign or malign disease in the left colon
- Cognitive ability to take part in the study and understand the information he/she receives about participating in the study
Exclusion
- Urgent medical condition requiring immediate care
- Health condition classified as ASA IV
- Albumin level less than 25 g/l
- Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease)
- Disease that requires more than one anastomosis during the surgical procedure
- Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery
- Contraindications to general anaesthesia
- Cognitive ability that limits the patient's ability to take part in the study and understand the information he/she received about participating in the study, or the patient does not agree to join the study
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01451008
Start Date
June 1 2009
End Date
September 1 2012
Last Update
July 8 2013
Active Locations (1)
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1
Skåne University Hospital
Malmo, Skåne County, Sweden, 20502