NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bernhard Dauser, MD, St John of God Hospital, Vienna

ClinicalTrials.gov Identifier:

NCT01056913

First received: January 24, 2010

Last updated: December 11, 2013

Last verified: December 2013

History of Changes

Purpose

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.

Condition	Intervention	Phase
Colonic Neoplasms Rectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Rectal Prolapse	Device: Compression Anastomosis Device Other: follow-up colonoscopy	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diverticulosis and Diverticulitis Pelvic Support Problems

Genetic and Rare Diseases Information Center resources: Rectal Neoplasm

U.S. FDA Resources

Further study details as provided by St John of God Hospital, Vienna:

Primary Outcome Measures:

Anastomotic Leakage [ Time Frame: 4-8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical Relevant Stenosis [ Time Frame: six months ] [ Designated as safety issue: No ]


Enrollment:	62
Study Start Date:	October 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NITI CAR27 (ColonRing)	Device: Compression Anastomosis Device Restoring intestinal continuity using the NITI CAR27 device Other Names: ColonRing BioDynamix Anastomosis Other: follow-up colonoscopy endoscopic exploration of anastomosis after complete healing

Eligibility


Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

benign and malign lesions of the colon and rectum

Exclusion Criteria:

advanced peritonitis (putrid, feculent)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056913

Sponsors and Collaborators

St John of God Hospital, Vienna

Investigators


Principal Investigator:	Friedrich Herbst, MD, FRCS	St John of God Hospital, Vienna

More Information

Additional Information:

About BioDynamix Anastomosis This link exits the ClinicalTrials.gov site

No publications provided by St John of God Hospital, Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2.


Responsible Party:	Bernhard Dauser, MD, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier:	NCT01056913 History of Changes
Other Study ID Numbers:	CT2
Study First Received:	January 24, 2010
Results First Received:	December 11, 2013
Last Updated:	December 11, 2013
Health Authority:	Austria: Ethikkommission

Keywords provided by St John of God Hospital, Vienna:


anastomotic leakage bleeding from the anastomotic region anastomotic stenosis

Additional relevant MeSH terms:


Colonic Neoplasms Diverticulitis Inflammatory Bowel Diseases Intestinal Diseases Neoplasms Rectal Neoplasms Rectal Prolapse Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms	Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Infection Intestinal Neoplasms Intraabdominal Infections Neoplasms by Site Pathological Conditions, Anatomical Pelvic Organ Prolapse Prolapse Rectal Diseases

ClinicalTrials.gov processed this record on February 25, 2015

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