Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
N/A
18 Years
N/A
18 Years
N/A
Open (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
Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
Inclusion Criteria:
1. Patient was > 18 years old at time of procedure
2. Patient underwent a technically successful open or laparoscopic colorectal, Low
Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
3. Patient treated in routine clinical practice
4. 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:
The rate of anastomotic leakage.
Outcome Description:
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:
6 weeks after the procedure
Safety Issue:
Yes
Authority:
United States: Institutional Review Board
Study ID:
RETROPRESS, CLPR-43-11-01
NCT ID:
NCT01880918
Start Date:
October 2012
Completion Date:
July 2013
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 |
|---|---|
| Florida Hospital, Center for Colon & Rectal Surgery | Atlamonte Springs, Florida 32701 |
| 18308 Murdock Circle, Suite 108 | Port Charlotte, Florida |
| CoxHealth Hospital, Colorectal Department | Springfield, Missouri 65807 |
