Condition category
Surgery
Date applied
25/05/2019
Date assigned
07/06/2019
Last edited
29/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Perioperative use of epidural analgesia reduces the 36-month postoperative mortality rate. This effect may be due to systemic effects of local anaesthetics or to a reduced stress response caused by the thoracic epidural analgesia itself.

Who can participate?
Patients scheduled to undergo elective open colon cancer surgery.

What does the study involve?
Patients records are followed up over a 4 year period following surgery.

What are the possible benefits and risks of participating?
None.

Where is the study run from?
Marienhospital Vechta gGmbH, Germany.

When is the study starting and how long is it expected to run for?
January 1997 to December 2015

Who is funding the study?
The study is funded by the investigator.

Who is the main contact?
Dr Christian Hönemann,
c.honemann@icloud.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christian Hönemann

ORCID ID

http://orcid.org/0000-0002-9658-253X

Contact details

arienstraße 6-8
Vechta
49377
Germany
+4915208961106
christian.hoenemann@kh-vec.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MarienVEC_12

Study information

Scientific title

Epidural anaesthesia reduces mortality after colon cancer surgery

Acronym

EARMAC

Study hypothesis

Epidural anaesthesia reduces mortality after colon cancer surgery

Ethics approval

Approved DATE, Ethikkommission der Aerztekammer Niedersachsen (Ethical Committee of the Aerztekammer Niedersachsen, ÄKN Ethikkommission, Berliner Allee 20, 30175 Hannover, Germany; 05113802208; ethikkommission@aekn.de), ref:

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Patients with elective colon cancer surgery

Intervention

Patient records were used to follow-up on outcomes over 4 years for patients who had undergone elective colon cancer surgery with or without thoracic epidural anesthesia/analgesia.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Mortality, measured by review of patient charts and a database of a local cancer database in Oldenburg, Germany

Secondary outcome measures

1. Perioperative complications
2. Stroke
3. Myocardial infarction
4. Blood transfusion
5. Duration of stay
All measured by review of patient charts and a database of a local cancer database in Oldenburg, Germany

Overall trial start date

01/01/2003

Overall trial end date

31/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Scheduled to undergo elective open colon cancer surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Non elective surgery
2. Laparoscopic surgery

Recruitment start date

01/01/1997

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Marienhospital Vechta gGmbH
Marienstraße 6-8
Vechhta
49377
Germany

Sponsor information

Organisation

Marienhospital Vechta gGmbH

Sponsor details

Marienstraße 6-8
Vechta
49377
Germany
+494441992933
christian.hoenemann@kh-vec.de

Sponsor type

Hospital/treatment centre

Website

www.marienhospital-vechta.de

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in BMC Anesthesiology

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/08/2019: Internal review. 06/06/2019: Trial’s existence confirmed by Aerztekammer Niedersachsen.