An observational study in Diverticulum, Colon, Colorectal Neoplasms and Crohn Disease, sponsored by novoGI. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by novoGI · Observational
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 171 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →novoGI is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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™
Creation of a circular Compression Anastomosis
Also known as: Compression Anaqstomosis Ring™(CAR™)27
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.
Time frame: 2-mo post-op
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)
Time frame: 2-mo post-op
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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