a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma, Rectal Prolapse, Intestinal Polyposis, Lymphoma, Endometriosis, Intestinal Volvulus
Both
Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma, Rectal Prolapse, Intestinal Polyposis, Lymphoma, Endometriosis, Intestinal Volvulus
Trial Information
a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
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.
Type of Study:
Observational
Study Design:
Time Perspective: Retrospective
Outcome Measure:
Rate of anastomotic leakage
Outcome Description:
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.
Outcome Time Frame:
2-mo post-op
Safety Issue:
Yes
Principal Investigator
Eran Choman, Msc
Investigator Role:
Study Director
Investigator Affiliation:
novoGI
Authority:
United States: Institutional Review Board
Study ID:
RETROPRESS
NCT ID:
NCT01301417
Start Date:
February 2011
Completion Date:
August 2011
Related Keywords:
- Diverticulum, Colon
- Colorectal Neoplasms
- Crohn Disease
- Colitis, Ulcerative
- Colostomy
- Ileostomy - Stoma
- Rectal Prolapse
- Intestinal Polyposis
- Lymphoma
- Endometriosis
- Intestinal Volvulus
- Compression Anastomosis
- Neoplasms
- Colitis
- Colitis, Ulcerative
- Colorectal Neoplasms
- Crohn Disease
- Diverticulum, Colon
- Diverticulum
- Endometriosis
- Lymphoma
- Prolapse
- Rectal Prolapse
- Ulcer
- Intestinal Volvulus
- Intestinal Polyposis
Name | Location |
|---|---|
| Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
