NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01056913

First Posted: January 26, 2010

Last Update Posted: January 29, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

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

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 Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

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

Primary Outcome Measures:

Anastomotic Leakage [ Time Frame: 4-8 weeks ]

Secondary Outcome Measures:

Clinical Relevant Stenosis [ Time Frame: six months ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted:	January 24, 2010
First Posted:	January 26, 2010
Results First Submitted:	December 11, 2013
Results First Posted:	January 29, 2014
Last Update Posted:	January 29, 2014
Last Verified:	December 2013

Keywords provided by Bernhard Dauser, MD, St John of God Hospital, Vienna:


anastomotic leakage bleeding from the anastomotic region anastomotic stenosis

Additional relevant MeSH terms:


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

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