NCT01148394

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

1.2 years

First QC Date

June 21, 2010

Last Update Submit

June 21, 2010

Conditions

Fast TrackEnhanced Recovery

Keywords

Colorectal surgerymultimodal rehabilitationfast trackearly feeding

Outcome Measures

Primary Outcomes (1)

  • Postoperative stay

    18 months

Secondary Outcomes (1)

  • Postoperative complications

    18 months

Study Arms (2)

Traditional

NO INTERVENTION

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

Other: Multimodal rehabilitation

Multimodal rehabilitation

ACTIVE COMPARATOR

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

Other: Multimodal rehabilitation

Interventions

Multimodal rehabilitationOTHER
Multimodal rehabilitationTraditional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent elective colorectal surgery between 2009 and 2010.
  • Signed informed consent
  • Live in Valencia metropolitan area

You may not qualify if:

  • Emergency surgery
  • No colonic resection
  • Unable to continue follow-up
  • Dependent on others for daily activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21345423DERIVED

Study Officials

  • Stephanie A Garcia Botello, MBChB

    Hospital Clinico Universitario Valencia

    PRINCIPAL INVESTIGATOR

  • Eduardo Garcia-Granero, MD

    Hospital Clinico Universitario, Valencia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

January 1, 2009

Primary Completion

March 1, 2010

Study Completion

June 1, 2010

Last Updated

June 22, 2010

Record last verified: 2010-06