Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis

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.

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Key information

Conditions

Diverticulum, Colon Colitis Colitis, Ulcerative Colonic Diseases Colorectal Neoplasms Colostomy Crohn Disease Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulum Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Hemic and Lymphatic Diseases Ileostomy - Stoma Immune System Diseases Immunoproliferative Disorders Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Intestinal Obstruction Intestinal Polyposis Intestinal Volvulus Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases Rectal Prolapse Torsion Abnormality Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ColonRing™

Device

Creation of a circular Compression Anastomosis

Other names: Compression Anaqstomosis Ring™(CAR™)27

Primary outcomes

Rate of anastomotic leakage

Time frame: 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 outcomes

Rate of other device related complications and measures during hospitalization and post procedure:

Time frame: 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)

Sponsors and collaborators

Lead sponsor

novoGI

Industry

Registry information

Official study title

a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

Acronym: RETROPRESS

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Feb 23, 2011
Registry last updated: Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed