Prehabilitation for patients undergoing major abdominal surgery
| ISRCTN | ISRCTN21151716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21151716 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/11/2014
- Registration date
- 04/12/2014
- Last edited
- 25/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
When people have surgery, it is common practice for them to undergo postoperative rehabilitation to help them recover from the procedure and improve clinical outcome. However, it is possible that prehabilitation, a training programme to improve physical fitness before the surgery takes place, may be of more benefit. We want to see how possible it is to run a study from a number of different hospitals that compares the effects of a comprehensive prehabilitation programme with standard care (postoperative rehabilitation). We will look at how a prehabilitation programme helps patients recover from major abdominal surgery and whether it results in a better health-related quality of life, better physical fitness level, less pain and a shorter stay in hospital than patients that receive standard care.
Who can participate?
Adults scheduled for major abdominal surgery.
What does the study involve?
Participants are randomly allocated to attend a prehabilitation programme before their surgery or a standard rehabilitation programme after surgery.
What are the possible benefits and risks of participating?
We believe that patients would benefit from the prehabilitation intervention. No risk for any patient involved in the study is expected.
Where is the study run from?
1. University Hospital "Lozano Blesa" (Hospital Clinico Universitario de Zaragoza) (Spain)
2. University Hospital de Elche (Hospital Univeritario de Elche) (Spain)
3. University Hospital Infanta Leonor (Hospital Infanta Leonor) (Spain)
4. University Hospital Fundación Jiménez Díaz (Fundacion Jimenez Diaz) (Spain)
5. Hospital de la Ribera (Spain)
6. Hospital La Mancha Centro (Spain)
When is the study starting and how long is it expected to run for?
March 2013 to July 2020
Who is funding the study?
Investigator initiated and funded (Spain)
Who is the main contact?
Professor Jose-M Ramirez
Contact information
Scientific
Department of Surgery
University Hospital
Zaragoza
50009
Spain
 ORCID ID |
0000-0001-7964-1166 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prehabilitation for patients undergoing major abdominal surgery with an enhanced recovery surgical protocol compared to traditional rehabilitation |
| Study objectives | Prehabilitation (the process of enhancing an individual’s functional capacity before scheduled surgery, aimed at improving the patient’s tolerance to surgical stress) increases functional capacity compared to traditional postoperative rehabilitation. This preoperative improvement will lead to earlier recovery and less morbidity |
| Ethics approval(s) | Ethical committee of Clinical Research, 01/01/ 2014. ref: CP.-CI. PI13/0167 |
| Health condition(s) or problem(s) studied | Patient scheduled for major abdominal surgery for benign or malignant conditions |
| Intervention | Prehabilitation program initiated before surgery against a rehabilitation program (traditional care) initiated after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Functional capacity as measured by the 6 minutes walking test (6MWT) |
| Secondary outcome measures | 1. Post-operative morbidity 2. Hospital Stay 3. Quality of life |
| Overall study start date | 01/03/2013 |
| Completion date | 01/07/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Patient scheduled for major abdominal surgery |
| Key exclusion criteria | Patient classified as ASA IV with severe systemic disease that is a constant threat to life |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 01/07/2019 |
Locations
Countries of recruitment
- Spain
Study participating centres
Zaragoza
15 50009
Spain
Spain
Spain
Spain
Spain
Spain
Sponsor information
University/education
San Juan Bosco 15
Zaragoza
50009
Spain
Government
Avda. San Juan Bosco 13
Zaragoza
50009
Spain
| Website | www.iacs.aragon.es |
|---|
Not defined
| Website | http://www.unizar.es/ |
|---|---|
"ROR" |
https://ror.org/012a91z28 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To be confirmed at a later date. |
| IPD sharing plan |
Editorial Notes
25/01/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2016 to 01/07/2019.
2. The overall trial end date was changed from 31/12/2016 to 01/07/2020.
