Colorectal SurgeryERASNCT00498290
The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery
A study testing enhanced recovery after surgery (ERAS) protocol in people with Colorectal Surgery, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to determine whether ERAS is safe and can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- enhanced recovery after surgery (ERAS) protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Sep 2006to Mar 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal surgery patients
- Age 20～80
- Without comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction
Who cannot join
- Emergency
- Combined other organ resection
- Age > 80
- Comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai, 200032
jianmin xu, professor, 008613501984869, xujmin@yahoo.com.cn
yunshi zhong, doctor, 008613564623481, zhong780124@sina.com
About this study
The purpose of this study is to determine whether ERAS is safe and can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery.
Read the detailed description
The key factors that keep a patient in hospital after uncomplicated major colorectal surgery include the need for parenteral analgesia(persistent pain), intravenous fluids (persistent gut dysfunction), and bed rest (persistent lack of mobility). These factors often overlap and interact to delay return of function. Obviously, postoperative complications will also prolong the time until recovery and ultimately length of stay. A clinical pathway, called Enhanced Recovery After Surgery(ERAS), to accelerate recovery after colonic resection based on a multimodal programme with optimal pain relief, stress reduction with regional anaesthesia, early enteral nutrition and early mobilisation has demonstrated improvements in physical performance, pulmonary function, body composition and a marked reduction of length of stay.
Comparison(s): A total of 500 cases colorectal surgery were randomized to receive ERAS protocol or the traditional protocol, such as mechanical bowl preparation, intravenous fluids until bowl movement recovery and bed rest.
- Conditions
- Colorectal Surgery
- Being tested
- enhanced recovery after surgery (ERAS) protocol, control
- Keywords
- Enhanced Recovery After Surgery Protocol(ERAS), Colorectal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced recovery after surgery (ERAS) protocolProcedure or surgery
An integrated protocol aims to allow patients to recover more quickly from major surgery, avoid medium-term sequelae of conventional postoperative care (e.g. decline in nutritional status and fatigue) and reduce health care costs by reducing hospital stay
controlProcedure or surgery
normal recovery protocol as usually
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | received enhanced recovery after surgery (ERAS) protocol in colorectal surgery Receives: Procedure: enhanced recovery after surgery (ERAS) protocol |
| B | No intervention | normal recovery protocol in colorectal surgery Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery
Measured: perioperation and until 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionMar 2010 (estimated)
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 Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- jianmin xu, professor, Study chair, department of general surgery, zhongshan hospital, fudan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498290
- Sponsor's protocol ID
- 2006-51
- Acronym
- ERAS
- Status last verified
- Mar 2009
- First submitted
- 9 Jul 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ren L, Zhu D, Wei Y, Pan X, Liang L, Xu J, Zhong Y, Xue Z, Jin L, Zhan S, Niu W, Qin X, Wu Z, Wu Z. Enhanced Recovery After Surgery (ERAS) program attenuates stress and accelerates recovery in patients after radical resection for colorectal cancer: a prospective randomized controlled trial. World J Surg. 2012 Feb;36(2):407-14. doi: 10.1007/s00268-011-1348-4.
PubMed 22102090
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00498290
- Acronym / sponsor ID
- ERAS / 2006-51
- Conditions
- Colorectal Surgery
- Keywords
- Enhanced Recovery After Surgery Protocol(ERAS), Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2010 (estimated)
- First posted
- 10 Jul 2007 (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.
The purpose of this study is to determine whether ERAS is safe and can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery.
Detailed description
The key factors that keep a patient in hospital after uncomplicated major colorectal surgery include the need for parenteral analgesia(persistent pain), intravenous fluids (persistent gut dysfunction), and bed rest (persistent lack of mobility). These factors often overlap and interact to delay return of function. Obviously, postoperative complications will also prolong the time until recovery and ultimately length of stay. A clinical pathway, called Enhanced Recovery After Surgery(ERAS), to accelerate recovery after colonic resection based on a multimodal programme with optimal pain relief, stress reduction with regional anaesthesia, early enteral nutrition and early mobilisation has demonstrated improvements in physical performance, pulmonary function, body composition and a marked reduction of length of stay.
Comparison(s): A total of 500 cases colorectal surgery were randomized to receive ERAS protocol or the traditional protocol, such as mechanical bowl preparation, intravenous fluids until bowl movement recovery and bed rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: enhanced recovery after surgery (ERAS) protocolreceived enhanced recovery after surgery (ERAS) protocol in colorectal surgery |
| B | No intervention | Procedure: controlnormal recovery protocol in colorectal surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Colorectal surgery patients
- Age 20～80
- Without comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction
Key exclusion criteria (4 listed)
- Emergency
- Combined other organ resection
- Age > 80
- Comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction
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 |
|---|---|---|
| enhanced recovery after surgery (ERAS) protocolAn integrated protocol aims to allow patients to recover more quickly from major surgery, avoid medium-term sequelae of conventional postoperative care (e.g. decline in nutritional status and fatigue) and reduce health care costs by reducing hospital stay | Procedure or surgery | A |
| controlnormal recovery protocol as usually | Procedure or surgery | B |
Primary outcome
safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery
Time frame: perioperation and until 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
- Derived from this study: PubMed 22102090Ren L, Zhu D, Wei Y, Pan X, Liang L, Xu J, Zhong Y, Xue Z, Jin L, Zhan S, Niu W, Qin X, Wu Z, Wu Z. Enhanced Recovery After Surgery (ERAS) program attenuates stress and accelerates recovery in patients after radical resection for colorectal cancer: a prospective randomized controlled trial. World J Surg. 2012 Feb;36(2):407-14. doi: 10.1007/s00268-011-1348-4.
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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.
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai, China
jianmin xu, professor study chair
department of general surgery, zhongshan hospital, fudan university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced recovery after surgery (ERAS) protocol in people with Colorectal Surgery, run by Fudan University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery (time frame: perioperation and until 30 days after surgery). 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 NCT00498290, 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 25 Mar 2009.