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

NCT01451008 | Completed Phase 1 DMC

• 1 other identifier: CARP-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anastomosis; Compression; Colon

Outcome Measures

Primary Outcomes (1)

• Complications, including anastomotic leakage, problems with ring evacuation

  Up to 14 days after operation

Secondary Outcomes (1)

• Time to evacuation of the CARP device

  1-2 week after operation

Interventions

Compression anastomotic ring-locking procedure (CARP) DEVICE

The Compression anastomotic ring-locking procedure (CARP) device is based on a set of rings to make a compression anastomosis between the intestinal ends.

Also known as: The rings are called RapAn

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 - 90 years (male or female)
• Planned resection due to benign or malign disease in the left colon
• Cognitive ability to take part in the study and understand the information he/she receives about participating in the study

You may not qualify if:

• Urgent medical condition requiring immediate care
• Health condition classified as ASA IV
• Albumin level less than 25 g/l
• Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease)
• Disease that requires more than one anastomosis during the surgical procedure
• Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery
• Contraindications to general anaesthesia
• 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

Sponsors & Collaborators

• Region Skane: lead
• Carponovum AB: collaborator

Study Sites (1)

Skåne University Hospital

Malmo, Skåne County, 20502, Sweden

Location

MeSH Terms

Conditions

Neoplasms; Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: October 13, 2011
• Study Start: June 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

SE (1)