NCT02715310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

March 7, 2016

Last Update Submit

March 22, 2016

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Postoperative Complications

    General Complications e.g. affecting lung, cardiovascular system, kidneys

    1 week

Secondary Outcomes (1)

  • Transplant Survival via Clinical Examination

    One week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Technische Universität München

Munich, Bavaria, 81675, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood parameters

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Denys Loeffelbein, PhD, MD, DDS

    Technical University Muncih

    STUDY CHAIR

Central Study Contacts

Thomas Mücke, PhD, MD, DDS

CONTACT

00494140thomas.muecke@tum.de

Florian Guell, MD

CONTACT

00494140florian.guell@tum.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 22, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

DE(1)