Enhanced Recovery Clinical Trial
Official title:
Impact of the Introduction of a Multimodal Rehabilitation Programme for Colorectal Patients. A Prospective Randomized Trial.
Verified date | June 2010 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Comité Ético de Investigación Clínica |
Study type | Interventional |
Introduction: Multimodal rehabilitation (MMR), combines various elements in the management
of the surgical patient which lead to a decrease in surgical stress and a more comfortable
and faster postoperative recovery.
Objective: To assess the introduction of MMR in a specialized Colorectal Unit and compare
the results with the traditional model assessing its´ efficacy as to recovery, and reduction
of hospital stay and costs.
Status | Completed |
Enrollment | 119 |
Est. completion date | June 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who underwent elective colorectal surgery between 2009 and 2010. - Signed informed consent - Live in Valencia metropolitan area Exclusion Criteria: - Emergency surgery - No colonic resection - Unable to continue follow-up - Dependent on others for daily activities |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Valencia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative stay | 18 months | No | |
Secondary | Postoperative complications | 18 months | Yes |
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