A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

NCT01880918 | Unknown

• 1 other identifier: RETROPRESS, CLPR-43-11-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

Compression Anastomosis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks after the procedure

Secondary Outcomes (1)

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

  6 weeks after the procedure.

Study Arms (1)

ColonRing

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent a laparoscopic or open Low Anterior resection with the creation of an anastomosis using the ColonRing in routine clinical practice.

You may qualify if:

• Patient was \> 18 years old at time of procedure
• Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
• Patient treated in routine clinical practice
• Patient underwent his/her first follow-up visit within two months post-surgery

Sponsors & Collaborators

• novoGI: lead

Study Sites (3)

Florida Hospital, Center for Colon & Rectal Surgery

Atlamonte Springs, Florida, 32701, United States

RECRUITING

18308 Murdock Circle, Suite 108

Port Charlotte, Florida, United States

RECRUITING

CoxHealth Hospital, Colorectal Department

Springfield, Missouri, 65807, United States

RECRUITING

MeSH Terms

Conditions

Diverticulum, Colon; Colorectal Neoplasms; Crohn Disease; Colitis, Ulcerative; Rectal Prolapse; Intestinal Polyposis; Lymphoma; Endometriosis; Intestinal Volvulus

Condition Hierarchy (Ancestors)

Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Inflammatory Bowel Diseases; Colitis; Pelvic Organ Prolapse; Prolapse; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Obstruction; Torsion Abnormality

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2013
• First Posted: June 19, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (3)