Enhanced recovery in colorectal surgery: a multicentre study from the Spanish Working group
| ISRCTN | ISRCTN16397735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16397735 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/09/2010
- Registration date
- 06/10/2010
- Last edited
- 06/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Ramirez
Scientific
Scientific
Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
Zaragoza
50009
Spain
Study information
| Study design | Observational non-randomised study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact ard-fast-track@googlegroups.com to request a patient information sheet |
| Scientific title | A multicentre prospective interventional study from the Spanish Working group into enhanced recovery in colorectal surgery |
| Study objectives | The implementation of an enhanced recovery after surgery protocol in major colorectal surgery reduces postoperative complications and hospital stays. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | Colorectal disease |
| Intervention | Colorectal surgery |
| Intervention type | Other |
| Primary outcome measure | Morbi-mortality, measured from operation to two months after surgery |
| Secondary outcome measures | Hospital stay, measured from operation up to release from hospital |
| Overall study start date | 01/01/2008 |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/08/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Servicio de Cirugia
Zaragoza
50009
Spain
50009
Spain
Sponsor information
Spanish Working Group on Multimodal Rehabilitation (Grupo Español de Rehabilitacion Multimodal [GERM]) (Spain)
Research organisation
Research organisation
Servicio de Cirugia
Hospital Clinico Universitario
San Juan Bosco 15
Zaragoza
50009
Spain
| Website | http://ftsurgery.com/ |
|---|
Funders
Funder type
Other
Investigator initiated and funded (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
