NCT01492946

Brief Summary

The aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. Elective surgical patients were screened with Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body composition. Outcome parameters were collected by patient chart review.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

December 14, 2011

Last Update Submit

January 20, 2017

Conditions

Nutritional Status

Keywords

MalnutritionPost-operative outcomePhase angleMUSTClavien Dindo classificationBioelectrical impedance analysis

Outcome Measures

Primary Outcomes (1)

  • Phase-angle

    preoperative

Secondary Outcomes (7)

  • body weight

    preoperative

  • body mass index (BMI)

    preoperative

  • preoperative weight loss

    3 month weight loss before operation

  • hip/waist ratio

    preoperative

  • Malnutrition Universal Screening Tool (MUST)

    preoperative

  • +2 more secondary outcomes

Study Arms (1)

Elective surgical patients

Elective surgical patients in the Charité University Berlin Campus Charité Mitte

Eligibility Criteria

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

Elective surgical patients

You may qualify if:

  • Elective surgical intervention
  • Patients must be 18 years or older
  • Ambulation
  • ASA-Score I-IV
  • bioelectrical impedance analysis to determine the phase angle

You may not qualify if:

  • Emergency surgery
  • Pregnancy
  • ASA Score V-VI
  • Amputated limbs
  • Pacemaker and defibrillators
  • Cerebrovascular events
  • Tattoos on the electrode locations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Claudia Spies, MD Prof.

    Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
study director

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 15, 2011

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

July 1, 2012

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

DE(1)