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Haemodynamic Monitoring in Head and Neck Cancer Patients (HMHN)

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. Identifier: NCT02715310
Recruitment Status : Unknown
Verified March 2016 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : March 22, 2016
Last Update Posted : March 23, 2016
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
In order to estimate the effect of fluid management in regard to postoperative complications this observatory study will document every kind of fluid intervention peri- and intraoperatively.

Condition or disease
Postoperative Complications

Detailed Description:

The extend of mass transfusions is known to correlate with postoperative complications. However, also crystalloid and colloidal infusions are under suspicion to cause postoperative complications. This study will capture any kind of fluid intervention perioperatively as well as intraoperatively. Intraoperative fluid management will be documented and matched with the operation steps respectively. The extend of fluid therapy will be correlated with general postoperative complications and especially with the survival of microvascular transplants.

For this purpose, there will be four questionaires. After informed consent, the first questionaire will cover the patient's history, risk factors and previous operations. The second questionaire will cover intraoperative fluid management, documented with the actual operation step. Furthermore, it will also intraoperative complications, cardiovascular-active medication. For closer monitoring, data from Picco will also be included. The third questionaire will be complete in the ICU covering similar content as the second questionaire. The last questionaire will cover the patient's progress on the general ward. Fluid management and tube feeding, as well as general postoperative complication and flap specific complications will be noted.

This study aims for 50-80 patients.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : March 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Primary Outcome Measures :
  1. Postoperative Complications [ Time Frame: 1 week ]
    General Complications e.g. affecting lung, cardiovascular system, kidneys

Secondary Outcome Measures :
  1. Transplant Survival via Clinical Examination [ Time Frame: One week ]
    Transplant Survival via Clinical Examination/ Need for further microvascular Transplant

Biospecimen Retention:   Samples Without DNA
Blood parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Full grown, able to consent patients admitted for major head and neck surgery with planned microvascular transplants for reconstruction due to tumors in the head and neck region.

Inclusion Criteria:

  • 18 years old or older
  • admitted for head and neck surgery with microvascular transplantation due to head and neck tumors

Exclusion Criteria:

  • Pregnancy
  • underage
  • missing informed consent
  • revisions and relapse operations
  • non tumor-associated operations
  • surgery without microvascular transplants

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 identifier (NCT number): NCT02715310

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Contact: Thomas Mücke, PhD, MD, DDS 00494140 ext 5866
Contact: Florian Guell, MD 00494140 ext 4994

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Department of Oral and Maxillofacial Surgery, Technische Universität München Recruiting
Munich, Bavaria, Germany, 81675
Contact: Thomas Mücke, PhD, MD, DDS    00494140 ext 5866   
Contact: Florian Guell, MD    00494140 ext 4994   
Sponsors and Collaborators
Technische Universität München
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Study Chair: Denys Loeffelbein, PhD, MD, DDS Technical University Muncih
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Responsible Party: Technische Universität München Identifier: NCT02715310    
Other Study ID Numbers: MKG HN 1
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes