Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01148394
Other study ID # FT-1
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02583711 - The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
Recruiting NCT05231473 - Impact Of The Nurse Enhanced Recovery After Surgery Coordinator On The Compliance In Colorectal Surgery (nursERAS-BCN) N/A
Withdrawn NCT04348981 - Preventing Cardiac Surgery Readmission With Patient Activity Tracking Technology N/A
Completed NCT06026475 - Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Oncosurgeries N/A
Recruiting NCT05503004 - Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial N/A
Completed NCT04360382 - Enhanced Recovery Versus Conventional Care After Cesarean Section
Not yet recruiting NCT05476003 - Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery N/A
Recruiting NCT03958825 - Open Versus Laparoscopic Left Hepatic Sectionectomy N/A