Condition category
Surgery
Date applied
20/11/2014
Date assigned
04/12/2014
Last edited
04/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 December 2016

Who is funding the study?
Investigator initiated and funded (Spain)

Who is the main contact?
Professor Jose-M Ramirez

Trial website

Contact information

Type

Scientific

Primary contact

Prof. Jose-M Ramirez

ORCID ID

http://orcid.org/0000-0001-7964-1166

Contact details

Department of Surgery
University Hospital
Zaragoza
50009
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prehabilitation for patients undergoing major abdominal surgery with an enhanced recovery surgical protocol compared to traditional rehabilitation

Acronym

Study hypothesis

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

Ethical committee of Clinical Research, 01/01/ 2014. ref: CP.-CI. PI13/0167

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2013

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patient scheduled for major abdominal surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Patient classified as ASA IV with severe systemic disease that is a constant threat to life

Recruitment start date

01/06/2013

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Spain

Trial participating centre

University Hospital "Lozano Blesa" (Hospital Clinico Universitario de Zaragoza)
Avda. San Juan Bosco
Zaragoza
15 50009
Spain

Trial participating centre

University Hospital de Elche (Hospital Univeritario de Elche)
Spain

Trial participating centre

University Hospital Infanta Leonor (Hospital Infanta Leonor)
Spain

Trial participating centre

University Hospital Fundación Jiménez Díaz (Fundacion Jimenez Diaz)
Spain

Trial participating centre

Hospital de la Ribera
Spain

Trial participating centre

Hospital La Mancha Centro
Spain

Sponsor information

Organisation

Department of Surgery, University Hospital of Zaragoza

Sponsor details

San Juan Bosco 15
Zaragoza
50009
Spain

Sponsor type

University/education

Website

Organisation

Biomedical Research Centre of Aragon (Grupo Español de Rehabilitación Multimodal (GERM))

Sponsor details

Avda. San Juan Bosco 13
Zaragoza
50009
Spain

Sponsor type

Government

Website

www.iacs.aragon.es

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes