Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01451008
• Date of registration: 26/09/2011
• Primary sponsor: Region Skane
• Public title: Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)
• Scientific title: Safety Study of Compression Anastomotic Ring-locking Procedure (CARP) in Patients Undergoing Colonic Resection
• Date of first enrolment: June 2009
• Target sample size: 25
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01451008
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Sweden

Contacts

• Name: Henrik Thorlacius, MD, PhD

• Name: Henrik Thorlacius, MD, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age between 18 - 90 years (male or female)

2. Planned resection due to benign or malign disease in the left colon

3. Cognitive ability to take part in the study and understand the information he/she
receives about participating in the study

Exclusion Criteria:

1. Urgent medical condition requiring immediate care

2. Health condition classified as ASA IV

3. Albumin level less than 25 g/l

4. Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease)

5. Disease that requires more than one anastomosis during the surgical procedure

6. Treatment with cortisone and/or other immunosuppressive medications less than one
month before surgery

7. Contraindications to general anaesthesia

8. 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Polyp

Intervention(s)

Device: Compression anastomotic ring-locking procedure (CARP)

Primary Outcome(s)

Complications, including anastomotic leakage, problems with ring evacuation [Time Frame: Up to 14 days after operation]

Secondary Outcome(s)

Time to evacuation of the CARP device [Time Frame: 1-2 week after operation]

Secondary ID(s)

CARP-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Carponovum