Beneficial effects of thoracic epidural anaesthesia on mortality after surgery for colon cancer
| ISRCTN | ISRCTN10994336 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10994336 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | MarienVEC_12 |
| Sponsor | Marienhospital Vechta gGmbH |
| Funder | Investigator initiated and funded |
- Submission date
- 25/05/2019
- Registration date
- 07/06/2019
- Last edited
- 29/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
arienstraße 6-8
Vechta
49377
Germany
 ORCID ID |
0000-0002-9658-253X |
|---|---|
| Phone | +4915208961106 |
| christian.hoenemann@kh-vec.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Epidural anaesthesia reduces mortality after colon cancer surgery |
| Study acronym | EARMAC |
| Study objectives | Epidural anaesthesia reduces mortality after colon cancer surgery |
| Ethics approval(s) | 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: |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Mortality, measured by review of patient charts and a database of a local cancer database in Oldenburg, Germany |
| Key secondary outcome measure(s) |
1. Perioperative complications |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 240 |
| Key inclusion criteria | Scheduled to undergo elective open colon cancer surgery |
| Key exclusion criteria | 1. Non elective surgery 2. Laparoscopic surgery |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Vechhta
49377
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/08/2019: Internal review.
06/06/2019: Trial’s existence confirmed by Aerztekammer Niedersachsen.
