NCT01451008

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Polyp

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-10-13
• Last updated: 2013-07-08

Locations

1 site across 1 country: Sweden