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Safety Study of Compression Anastomotic Ring-locking Procedure (CARP) in Patients Undergoing Colonic Resection


Phase 1
18 Years
90 Years
Open (Enrolling)
Both
Cancer, Polyp

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Trial Information

Safety Study of Compression Anastomotic Ring-locking Procedure (CARP) in Patients Undergoing Colonic Resection


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complications, including anastomotic leakage, problems with ring evacuation

Outcome Time Frame:

Up to 14 days after operation

Safety Issue:

Yes

Authority:

Sweden: Regional Ethical Review Board

Study ID:

CARP-002

NCT ID:

NCT01451008

Start Date:

June 2009

Completion Date:

September 2012

Related Keywords:

  • Cancer
  • Polyp
  • Anastomosis
  • Compression
  • Colon

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