A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

Lymphoma Clinical Trial

Official title:

Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01880918
• Other study ID #: RETROPRESS, CLPR-43-11-01
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2013
• Last updated: June 16, 2013
• Start date: October 2012
• Est. completion date: July 2013

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Locations

Country	Name	City	State
United States	Florida Hospital, Center for Colon & Rectal Surgery	Atlamonte Springs	Florida
United States	18308 Murdock Circle, Suite 108	Port Charlotte	Florida
United States	CoxHealth Hospital, Colorectal Department	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
novoGI

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Rate of other device related complications and measures during hospitalization and post procedure.	The Following complications will be examined: 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); The following post operative measures will be reported: Hospitalization duration (two dates will be recorded: ready for discharge and discharge). The latter noting where the patient was discharged to - e.g. nursing home or home. First day to first postoperative flatus. First day to first postoperative bowel movements. First day of first postoperative toleration of liquids and solids (time to "keeping them down")	6 weeks after the procedure.	Yes