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

This study has been completed.
Sponsor:
Collaborator:
Carponovum
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01451008
First received: September 26, 2011
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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 an anastomosis can cause serious consequences, such as abdominal infections and/or sepsis. Early detection of anastomotic leakage is the best way to avoid serious abdominal infections. The methods that are used today to detect leaks are unfortunately not very accurate. These methods include monitoring symptoms, temperature, and CRP-levels, and performing abdominal examinations and tomography scans. Because of the difficulties in objectively assessing these parameters, the anastomotic leaks are often diagnosed late. When reoperation is required, a permanent stoma may be made at the level of the sigmoid colon. The CARP system has been developed to achieve a safe anastomosis. The CARP is designed to providing an improved contact surface between the two intestinal ends and the ability to precisely investigate the anastomosis during and after surgery using the catheters of the CARP system. Standardized use of the CARP to anastomose the large intestine may provide significant advantages in the field of colorectal surgery.


Condition Intervention Phase
Cancer
Polyp
Device: Compression anastomotic ring-locking procedure (CARP)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study of Compression Anastomotic Ring-locking Procedure (CARP) in Patients Undergoing Colonic Resection

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Complications, including anastomotic leakage, problems with ring evacuation [ Time Frame: Up to 14 days after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to evacuation of the CARP device [ Time Frame: 1-2 week after operation ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Compression anastomotic ring-locking procedure (CARP)
    The Compression anastomotic ring-locking procedure (CARP) device is based on a set of rings to make a compression anastomosis between the intestinal ends.
    Other Name: The rings are called RapAn
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451008

Locations
Sweden
Skåne University Hospital
Malmö, Skåne, Sweden, 20502
Sponsors and Collaborators
Region Skane
Carponovum
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01451008     History of Changes
Other Study ID Numbers: CARP-002
Study First Received: September 26, 2011
Last Updated: July 5, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Anastomosis
Compression
Colon

ClinicalTrials.gov processed this record on August 26, 2014