Colitis, Ulcerative, Colorectal Neoplasms, Colostomy, Crohn Disease, Diverticulum, Colon, Endometriosis, Ileostomy - Stoma, Intestinal Polyposis, Intestinal Volvulus, Lymphoma, Rectal Prolapse
Conditions
Keywords
Compression Anastomosis
Brief summary
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.
Interventions
DEVICEColonRing™
Creation of a circular Compression Anastomosis
Sponsors
novoGI
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of anastomotic leakage | 2-mo post-op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of other device related complications and measures during hospitalization and post procedure: | 2-mo post-op | 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) |
Countries
United States
Outcome results
None listed