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Completed

NCT Number: NCT01451008

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

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.

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Key information

Conditions

Cancer Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp Polyps

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Skåne University Hospital

Malmö, Skåne County, 20502, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: The rings are called RapAn

Primary outcomes

  1. Complications, including anastomotic leakage, problems with ring evacuation

    Time frame: Up to 14 days after operation

Secondary outcomes

  1. Time to evacuation of the CARP device

    Time frame: 1-2 week after operation

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Carponovum AB

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 13, 2011
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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