Clinical trial NCT01451008: Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)
Official title: Safety Study of Compression Anastomotic Ring-locking Procedure (CARP) in Patients Undergoing Colonic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Polyp
Keywords: Anastomosis
Compression
Colon
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Carponovum AB
First posted: 2011-10-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Complications, including anastomotic leakage, problems with ring evacuation
timeFrame: Up to 14 days after operation
Secondary outcomes:
measure: Time to evacuation of the CARP device
timeFrame: 1-2 week after operation
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
state: Skåne
Study officials:
References: