Enhanced Recovery After Colorectal Surgery

Not Applicable

Completed

• Conditions: Fast Track; Enhanced Recovery
• Interventions: Other: Multimodal rehabilitation

• Registration Number: NCT01148394
• Lead Sponsor: University of Valencia

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-03
• Status Verified: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Last Update Submitted: 2010-06-21
• Study First Posted: 2010-06-22
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional	Multimodal rehabilitation	Involves traditional management of patients with preoperative mechanical bowel preparation, no preoperative education, nasogastric tube, delayed feeding and mobilisation, use of drains
Multimodal rehabilitation	Multimodal rehabilitation	Involves preoperative patient education, no preoperative mechanical bowel preparation, no nasogastric tube, early oral feeding and mobilisation, physiotherapy

Primary Outcome Measures

Name	Time	Method
Postoperative stay	18 months

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	18 months