Enhanced Recovery After Colorectal Surgery

Enhanced Recovery Clinical Trial

Official title:

Impact of the Introduction of a Multimodal Rehabilitation Programme for Colorectal Patients. A Prospective Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148394
• Other study ID #: FT-1
• Status: Completed
• Phase: N/A
• First received: June 21, 2010
• Last updated: June 21, 2010
• Start date: January 2009
• Est. completion date: June 2010

Study information

• 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

Clinical Trial Summary

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.

Description:

Materials y Methods: A prospective randomized trial was conducted which analyzed 119 patients who underwent elective colorectal surgery between 2009 and 2010. 58 patients were assigned to the traditional group and 61 patients to the MMR group. MMR included preoperative education, early feeding and mobilisation.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enhanced Recovery
• Fast Track

Intervention

Other:
• Multimodal rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative stay		18 months	No
Secondary	Postoperative complications		18 months	Yes