Enhanced Recovery After Colorectal Surgery

NCT ID: NCT01148394

Last Updated: 2010-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Fast Track Enhanced Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional

Involves traditional management of patients with preoperative mechanical bowel preparation, no preoperative education, nasogastric tube, delayed feeding and mobilisation, use of drains

Group Type NO_INTERVENTION

Multimodal rehabilitation

Intervention Type OTHER

Multimodal rehabilitation

Involves preoperative patient education, no preoperative mechanical bowel preparation, no nasogastric tube, early oral feeding and mobilisation, physiotherapy

Group Type ACTIVE_COMPARATOR

Multimodal rehabilitation

Intervention Type OTHER

Interventions

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Multimodal rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinico Universitario, Valencia

Principal Investigators

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Stephanie A Garcia Botello, MBChB

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico Universitario Valencia

Eduardo Garcia-Granero, MD

Role: STUDY_CHAIR

Hospital Clinico Universitario, Valencia

References

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Garcia-Botello S, Canovas de Lucas R, Tornero C, Escamilla B, Espi-Macias A, Esclapez-Valero P, Flor-Lorente B, Garcia-Granero E. [Implementation of a perioperative multimodal rehabilitation protocol in elective colorectal surgery. A prospective randomised controlled study]. Cir Esp. 2011 Mar;89(3):159-66. doi: 10.1016/j.ciresp.2010.12.004. Epub 2011 Feb 22. Spanish.

Reference Type DERIVED
PMID: 21345423 (View on PubMed)

Other Identifiers

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FT-1

Identifier Type: -

Identifier Source: org_study_id

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