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

NCT01301417 | Completed

• 1 other identifier: RETROPRESS
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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 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.

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)

• Rate of anastomotic leakage

  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.

  2-mo post-op

Secondary Outcomes (1)

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

  2-mo post-op

Study Arms (1)

ColonRing™

Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice

Device: ColonRing™

Interventions

ColonRing™ DEVICE

Creation of a circular Compression Anastomosis

Also known as: Compression Anaqstomosis Ring™(CAR™)27

ColonRing™

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 colorectal 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 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

Sponsors & Collaborators

• novoGI: lead

Study Sites (1)

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Location

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 Officials

• Eran Choman, Msc

  novoGI

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 20, 2011
• First Posted: February 23, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)