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Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis (RETROPRESS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
novoGI
ClinicalTrials.gov Identifier:
NCT01301417
First received: February 20, 2011
Last updated: June 4, 2013
Last verified: June 2013

February 20, 2011
June 4, 2013
February 2011
August 2011   (final data collection date for primary outcome measure)
Rate of anastomotic leakage [ Time Frame: 2-mo post-op ] [ Designated as safety issue: Yes ]
The primary study outcome is the rate of anastomotic leakage. Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
Same as current
Complete list of historical versions of study NCT01301417 on ClinicalTrials.gov Archive Site
Rate of other device related complications and measures during hospitalization and post procedure: [ Time Frame: 2-mo post-op ] [ Designated as safety issue: Yes ]

The following complications will be examined for relation to the device:

Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess).

Readmission, re-operation, death within two months of the procedure. Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)

Same as current
Not Provided
Not Provided
 
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice.

  • Diverticulum, Colon
  • Colorectal Neoplasms
  • Crohn Disease
  • Colitis, Ulcerative
  • Colostomy
  • Ileostomy - Stoma
  • Rectal Prolapse
  • Intestinal Polyposis
  • Lymphoma
  • Endometriosis
  • Intestinal Volvulus
Device: ColonRing™
Creation of a circular Compression Anastomosis
Other Name: Compression Anaqstomosis Ring™(CAR™)27
ColonRing™
Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice
Intervention: Device: ColonRing™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient was > 18 years old at time of procedure
  • Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™
  • Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use
  • Patient underwent his/her first follow-up visit within two months post-surgery

Exclusion Criteria:

  • No exclusion criteria have been defined for this data collection.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301417
RETROPRESS
No
novoGI
novoGI
Not Provided
Study Director: Eran Choman, Msc novoGI
novoGI
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP