NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

NCT ID: NCT01056913

Last Updated: 2014-01-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Neoplasms Rectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Rectal Prolapse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NITI CAR27 (ColonRing)

Group Type OTHER

Compression Anastomosis Device

Intervention Type DEVICE

Restoring intestinal continuity using the NITI CAR27 device

follow-up colonoscopy

Intervention Type OTHER

endoscopic exploration of anastomosis after complete healing

Interventions

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Compression Anastomosis Device

Restoring intestinal continuity using the NITI CAR27 device

Intervention Type DEVICE

follow-up colonoscopy

endoscopic exploration of anastomosis after complete healing

Intervention Type OTHER

Other Intervention Names

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ColonRing BioDynamix Anastomosis

Eligibility Criteria

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Inclusion Criteria

* benign and malign lesions of the colon and rectum

Exclusion Criteria

* advanced peritonitis (putrid, feculent)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St John of God Hospital, Vienna

OTHER

Sponsor Role lead

Responsible Party

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Bernhard Dauser, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Friedrich Herbst, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

St John of God Hospital, Vienna

References

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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.

Reference Type DERIVED
PMID: 21541799 (View on PubMed)

Related Links

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http://www.nitisurgical.com

About BioDynamix Anastomosis

Other Identifiers

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CT2

Identifier Type: -

Identifier Source: org_study_id

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