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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01451008
Enrollment
25
Registered
2011-10-13
Start date
2009-06-30
Completion date
2012-09-30
Last updated
2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Polyp

Keywords

Anastomosis, Compression, Colon

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.

Interventions

DEVICECompression 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.

Sponsors

Carponovum AB
CollaboratorINDUSTRY
Region Skane
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Complications, including anastomotic leakage, problems with ring evacuationUp to 14 days after operation

Secondary

MeasureTime frame
Time to evacuation of the CARP device1-2 week after operation

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026