Complication of Surgical and Medical Care.NCT01400711
Enhanced Recovery After Surgery in Major Intrabdominal Procedures.
A study testing ERAS perioperative care and Traditional in people with Complication of Surgical and Medical Care., run by St. Andrew's General Hospital, Patras, Greece at 1 site in Greece.
Trial summary
Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating the stress response to surgery and enabling rapid recovery. There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative… Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Complication of Surgical and Medical Care.
- What is being tested?
- ERAS perioperative care and Traditional
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2010to Apr 2011
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery
- ASA grade < 4
Who cannot join
- Emergency surgery
- ASA grade > 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery (ERAS) Versus Conventional Postoperative Care in Patients Undergoing Major Intra-abdominal Surgery.
Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating the stress response to surgery and enabling rapid recovery. There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of traditional treatment. However, few studies exist about the implication of ERAS programs in major upper abdominal surgery patients.
The aim of this study was to compare morbidity, mortality and length of stay in patients undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving either conventional postoperative care or an ERAS program.
- Being tested
- ERAS perioperative care, Traditional
- Keywords
- Fast-tract surgery, Enhanced recovery after surgery, multimodal surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS perioperative careOther
Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.
TraditionalOther
Nasogastric tube until bowel function, late oral eating, opioid analgesics.
| Study group | Role | What they receive |
|---|---|---|
| ERAS patients | Active comparator | Patients planned to undergoing major intrabdominal surgery, following the ERAS perioperative care. Receives: Other: ERAS perioperative care |
| Control patients | Active comparator | Patients planned to undergo major intrabdominal surgery, following the conventional perioperative care. Receives: Other: Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity.
Measured: 30 days after surgery
Secondary outcomes (1)
Mortality.
Measured: 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 posted22 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionApr 2011
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 Complication of Surgical and Medical Care.Studies of the same condition, open and under way.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Andrew's General Hospital, Patras, Greece
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400711
- Sponsor's protocol ID
- 1VA
- Status last verified
- Aug 2010
- First submitted
- 20 Jun 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
PubMed 19841366
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery (ERAS) Versus Conventional Postoperative Care in Patients Undergoing Major Intra-abdominal Surgery.
- ClinicalTrials.gov ID
- NCT01400711
- Acronym / sponsor ID
- 1VA
- Keywords
- Fast-tract surgery, Enhanced recovery after surgery, multimodal surgery.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- St. Andrew's General Hospital, Patras, GreeceUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Jul 2011 (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.
Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating the stress response to surgery and enabling rapid recovery. There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of traditional treatment. However, few studies exist about the implication of ERAS programs in major upper abdominal surgery patients.
The aim of this study was to compare morbidity, mortality and length of stay in patients undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving either conventional postoperative care or an ERAS program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS patients | Active comparator | Other: ERAS perioperative carePatients planned to undergoing major intrabdominal surgery, following the ERAS perioperative care. |
| Control patients | Active comparator | Other: TraditionalPatients planned to undergo major intrabdominal surgery, following the conventional perioperative care. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective surgery
- ASA grade < 4
Key exclusion criteria (2 listed)
- Emergency surgery
- ASA grade > 3
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 |
|---|---|---|
| ERAS perioperative carePatient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics. | Other | ERAS patients |
| TraditionalNasogastric tube until bowel function, late oral eating, opioid analgesics. | Other | Control patients |
Primary outcome
Morbidity.
Time frame: 30 days after surgery
1 secondary outcome
Mortality.
Time frame: 30 days after surgery
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 Jul 2011.
- Results publication: PubMed 19841366Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS perioperative care and Traditional in people with Complication of Surgical and Medical Care., run by St. Andrew's General Hospital, Patras, Greece at 1 site in Greece.
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 2 inclusion and 2 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 Jul 2011. 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 Greece. 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?
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?
Morbidity. (time frame: 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 NCT01400711, 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 Jul 2011.