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

Creation of a circular Compression Anastomosis

ColonRing™

Eran Choman, Msc

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.

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

a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

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.

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)

novoGI

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.

Dr. Matthew Albert, MD

Leslee Cunnion

Dr. Domingo E. Galliano Jr., MD

Kathleen Lueck

Dr. Domingo E. Galiano Jr., MD

Dr. Jose Dominguez, MD

Kami Oster

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.

A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

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

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.

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")

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis	NCT01301417	Diverticulum, C... Colorectal Neop... Crohn Disease Colitis, Ulcera... Colostomy Ileostomy - Sto... Rectal Prolapse Intestinal Poly... Lymphoma Endometriosis Intestinal Volv...	ColonRing™	18 Years -	novoGI
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis	NCT01301417	Diverticulum, C... Colorectal Neop... Crohn Disease Colitis, Ulcera... Colostomy Ileostomy - Sto... Rectal Prolapse Intestinal Poly... Lymphoma Endometriosis Intestinal Volv...	ColonRing™	18 Years -	novoGI
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing	NCT01880918	Diverticulum, C... Colorectal Neop... Crohn Disease Colitis, Ulcera... Colostomy Ileostomy - Sto... Rectal Prolapse Intestinal Poly... Lymphoma Endometriosis Intestinal Volv...		18 Years -	novoGI

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