Condition category
Digestive System
Date applied
19/09/2010
Date assigned
06/10/2010
Last edited
06/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Ramirez

ORCID ID

Contact details

Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
Zaragoza
50009
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A multicentre prospective interventional study from the Spanish Working group into enhanced recovery in colorectal surgery

Acronym

Study hypothesis

The implementation of an enhanced recovery after surgery protocol in major colorectal surgery reduces postoperative complications and hospital stays.

Ethics approval

No specific ethical requirements for this study; informed by Hospital Ethical Board that ethics approval was not required as this is an observational non-randomised study based on the best available evidence.

Study design

Observational non-randomised study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact ard-fast-track@googlegroups.com to request a patient information sheet

Condition

Colorectal disease

Intervention

Colorectal surgery

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Morbi-mortality, measured from operation to two months after surgery

Secondary outcome measures

Hospital stay, measured from operation up to release from hospital

Overall trial start date

01/01/2008

Overall trial end date

31/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over, either sex
2. Programmed for surgery for colorectal cancer without the need for a stoma or any further surgical procedure

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Need for emergency surgery
2. American Society of Anaesthesiologists (ASA) class IV
3. Need for a colostomy or ileostomy
4. Inability to provide informed consent
5. Diabetes
6. Slow evacuation previously documented by a digestive medicine unit

Recruitment start date

01/01/2008

Recruitment end date

31/08/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Servicio de Cirugia
Zaragoza
50009
Spain

Sponsor information

Organisation

Spanish Working Group on Multimodal Rehabilitation (Grupo Español de Rehabilitacion Multimodal [GERM]) (Spain)

Sponsor details

Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
Zaragoza
50009
Spain

Sponsor type

Research organisation

Website

http://ftsurgery.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes