Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007820

Trial Description

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Title

Clinical feasibility trial of endoscopic techniques in coronary bypass surgery

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Trial Acronym

nrTECAB

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study investigates the feasability of total endoscopic coronary bypass grafting without the help of a telemanipulator ("robot"). Patients with coronary artery disease in need for a single graft to the front side of the heart are included. Three to four access tubes (ports) are introduced via small skin incisions (about 1-1,5 cm each) at the left side of the chest. Through these ports, camera and working instruments are introduced. Under exclusive vision of a special camera system the inner chest wall artery is harvested and then sutured as a bypass to the blocked vessel on the front side of the heart. During the suturing, cardiopulmonary bypass is connected to the body through the artery and vein of the groin.

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Brief Summary in Scientific Language

The feasibility of non-robotic total endoscopic coronary bypass grafting (nrTECAB) is investigated in 20 patients. Under exclusive vision with an endoscopic camera system, the left internal mammary artery (LIMA) is harvested. Cardiopulmonary bypass is established via groin vessels. The ascending aorta is blocked with a balloon and cardioplegia is given into the aortic root. In cardioplegic arrest and with exclusive vision via endoscopic camera, LIMA is grafted to the left anterior descending coronary artery (LAD) with a running suture.

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Organizational Data

  •   DRKS00007820
  •   2015/02/24
  •   [---]*
  •   yes
  •   Approved
  •   82/14, Ethik-Kommission der Universität Ulm
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I25.9 -  Chronic ischaemic heart disease, unspecified
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Interventions/Observational Groups

  •   Interventional feasibility study operating on a group of patients for coronary artery disease. The coronary bypass operation is performed in total endoscopic technique.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Performance of operation without opening of the chest, performance of all intrathoracic parts of the operation exclusively with endoscopic vision

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Secondary Outcome

postoperative myocardial infarction, stroke, intubation time, time up to discharge

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/06/24
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

1. Stable coronary artery disease and
2. Stenosis > 75% or occlusion of the left anterior descending artery and
3. Other coronary arteries are free of disease or with no relevant disease or disease without interventional or surgical options or with disease which can be treated interventionally, what has to be confirmed by the consulting cardiologist and
4. any anticoagulation stopped at least three days before surgery

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Exclusion Criteria

1. Emergency operation
2. Coagulation disorder of any reason (inborn or aquired)
3. Contraindication for postoperative platelet inhibiting medication
4. left ventricular function < 35%
5. Age < 18 years, > 85 years,
6. Anatomy of the chest (e.g. deformity) hampering endoscopic access
7. Severely impaired lung function (FEV1 < 50% of normal value or < 1 liter/sec)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Herz-, Thorax- und GefäßchirurgieUniversitätsklinik
    • Mr.  Dr. med.  Hagen  Gorki 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Univeristät UlmKlinik für Herz-, Thorax- und Gefäßchirurgie
    • Mr.  Dr. med.  Hagen  Gorki 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Univeristät UlmKlinik für Herz-, Thorax- und Gefäßchirurgie
    • Mr.  Dr. med.  Hagen  Gorki 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
    end of 1:1-Block address public-contact
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Sources of Monetary or Material Support

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    • Univeristät UlmKlinik für Herz-, Thorax- und Gefäßchirurgie
    • Mr.  Dr. med.  Hagen  Gorki 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.