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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451008
• Other study ID #: CARP-002
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2011
• Last updated: July 5, 2013
• Start date: June 2009
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Polyp

Intervention

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.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Carponovum AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications, including anastomotic leakage, problems with ring evacuation		Up to 14 days after operation	Yes
Secondary	Time to evacuation of the CARP device		1-2 week after operation	Yes