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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
Open (Enrolling)
Both
Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma, Rectal Prolapse, Intestinal Polyposis, Lymphoma, Endometriosis, Intestinal Volvulus

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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 SurgeryAtlamonte Springs, Florida  32701
18308 Murdock Circle, Suite 108Port Charlotte, Florida  
CoxHealth Hospital, Colorectal DepartmentSpringfield, Missouri  65807