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NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

Primary Purpose

Colonic Neoplasms, Rectal Neoplasms, Diverticulitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Compression Anastomosis Device
follow-up colonoscopy
Sponsored by
St John of God Hospital, Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms focused on measuring anastomotic leakage, bleeding from the anastomotic region, anastomotic stenosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • benign and malign lesions of the colon and rectum

Exclusion Criteria:

  • advanced peritonitis (putrid, feculent)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    NITI CAR27 (ColonRing)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Anastomotic Leakage

    Secondary Outcome Measures

    Clinical Relevant Stenosis

    Full Information

    First Posted
    January 24, 2010
    Last Updated
    December 11, 2013
    Sponsor
    St John of God Hospital, Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01056913
    Brief Title
    NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
    Official Title
    Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St John of God Hospital, Vienna

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Neoplasms, Rectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Rectal Prolapse
    Keywords
    anastomotic leakage, bleeding from the anastomotic region, anastomotic stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NITI CAR27 (ColonRing)
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Compression Anastomosis Device
    Other Intervention Name(s)
    ColonRing, BioDynamix Anastomosis
    Intervention Description
    Restoring intestinal continuity using the NITI CAR27 device
    Intervention Type
    Other
    Intervention Name(s)
    follow-up colonoscopy
    Intervention Description
    endoscopic exploration of anastomosis after complete healing
    Primary Outcome Measure Information:
    Title
    Anastomotic Leakage
    Time Frame
    4-8 weeks
    Secondary Outcome Measure Information:
    Title
    Clinical Relevant Stenosis
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: benign and malign lesions of the colon and rectum Exclusion Criteria: advanced peritonitis (putrid, feculent)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Friedrich Herbst, MD, FRCS
    Organizational Affiliation
    St John of God Hospital, Vienna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21541799
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.nitisurgical.com
    Description
    About BioDynamix Anastomosis

    Learn more about this trial

    NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

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