A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

novoGI

Status: Unknown

Conditions: Colitis, Ulcerative; Rectal Prolapse; Ileostomy - Stoma; Colostomy; Diverticulum, Colon; Intestinal Volvulus; Endometriosis; Intestinal Polyposis; Lymphoma; Colorectal Neoplasms; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01880918

RETROPRESS, CLPR-43-11-01

Details and patient eligibility

About

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 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

ColonRing

Description:

The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.