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

Lymphoma Clinical Trial

— RETROPRESS  

Official title:

a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301417
• Other study ID #: RETROPRESS
• Status: Completed
• Phase: N/A
• First received: February 20, 2011
• Last updated: June 4, 2013
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: June 2013
• Source: novoGI
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Device:
• ColonRing™
Creation of a circular Compression Anastomosis

Locations

Country	Name	City	State
United States	Southern Regional Medical Center	Riverdale	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
novoGI

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Rate of other device related complications and measures during hospitalization and post procedure:	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)	2-mo post-op	Yes