Fast TrackNCT01148394
Enhanced Recovery After Colorectal Surgery
A study testing Multimodal rehabilitation in people with Fast Track and Enhanced Recovery, run by University of Valencia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fast Track, Enhanced Recovery
- What is being tested?
- Multimodal rehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent elective colorectal surgery between 2009 and 2010.
- Signed informed consent
- Live in Valencia metropolitan area
Who cannot join
- Emergency surgery
- No colonic resection
- Unable to continue follow-up
- Dependent on others for daily activities
About this study
Official title: Impact of the Introduction of a Multimodal Rehabilitation Programme for Colorectal Patients. A Prospective Randomized Trial.
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.
Read the 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.
- Conditions
- Fast Track, Enhanced Recovery
- Being tested
- Multimodal rehabilitation
- Keywords
- Colorectal surgery, multimodal rehabilitation, fast track, early feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Multimodal rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative stay
Measured: 18 months
Secondary outcomes (1)
Postoperative complications
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fast TrackStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Investigators
- Stephanie A Garcia Botello, MBChB, Principal investigator, Hospital Clinico Universitario ValenciaEduardo Garcia-Granero, MD, Study chair, Hospital Clinico Universitario, Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148394
- Sponsor's protocol ID
- FT-1
- Status last verified
- Jun 2010
- First submitted
- 21 Jun 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21345423
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Introduction of a Multimodal Rehabilitation Programme for Colorectal Patients. A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT01148394
- Acronym / sponsor ID
- FT-1
- Conditions
- Fast Track, Enhanced Recovery
- Keywords
- Colorectal surgery, multimodal rehabilitation, fast track, early feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | No intervention | Other: Multimodal rehabilitationInvolves traditional management of patients with preoperative mechanical bowel preparation, no preoperative education, nasogastric tube, delayed feeding and mobilisation, use of drains |
| Multimodal rehabilitation | Active comparator | Other: Multimodal rehabilitationInvolves preoperative patient education, no preoperative mechanical bowel preparation, no nasogastric tube, early oral feeding and mobilisation, physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent elective colorectal surgery between 2009 and 2010.
- Signed informed consent
- Live in Valencia metropolitan area
Key exclusion criteria (4 listed)
- Emergency surgery
- No colonic resection
- Unable to continue follow-up
- Dependent on others for daily activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal rehabilitation | Other | Multimodal rehabilitation, Traditional |
Primary outcome
Postoperative stay
Time frame: 18 months
1 secondary outcome
Postoperative complications
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Derived from this study: PubMed 21345423Garcia-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A Garcia Botello, MBChB principal investigator
Hospital Clinico Universitario Valencia
Eduardo Garcia-Granero, MD study chair
Hospital Clinico Universitario, Valencia
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal rehabilitation in people with Fast Track and Enhanced Recovery, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative stay (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.