Enhanced Recovery After SurgeryPhase 1NCT03271606
ERAS in Video-assisted Mediastinal Surgery
A Phase 1 study testing ERAS and Traditional measures in people with Enhanced Recovery After Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Enhanced Recovery After Surgery
- What is being tested?
- ERAS and Traditional measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2017to 23 Feb 2018
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients elective mediastinal surgery;
- BMI 18-30 kg/m2.
Who cannot join
- Patient refuse;
- ASA≥3;
- Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
chao liang, Ph.D, 15921679955, superwm226@aliyun.com
About this study
Official title: The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery
This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.
Read the detailed description
Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.
- Conditions
- Enhanced Recovery After Surgery
- Being tested
- ERAS, Traditional measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASCombination product
The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery
Traditional measuresCombination product
The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | The patients in this group receive enhanced measures perioperatively Receives: Combination Product: ERAS |
| Traditional group | Active comparator | The patients in this group receive traditional measures perioperatively Receives: Combination Product: Traditional measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
15-item quality of recovery scale (QoR-15)
This scale mainly reflects the patient's status
Measured: At preoperative vist
15-item quality of recovery scale (QoR-15)
This scale mainly reflects the patient's status
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start23 Aug 2017
- Primary completion23 Feb 2018 (estimated)
- Study completion23 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271606
- Sponsor's protocol ID
- zs2017822
- Status last verified
- Sep 2017
- First submitted
- 23 Aug 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery
- ClinicalTrials.gov ID
- NCT03271606
- Acronym / sponsor ID
- zs2017822
- Conditions
- Enhanced Recovery After Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 23 Feb 2018 (estimated)
- Study completion
- 23 Feb 2018 (estimated)
- First posted
- 5 Sep 2017 (actual)
- 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.
This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.
Detailed description
Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Combination Product: ERASThe patients in this group receive enhanced measures perioperatively |
| Traditional group | Active comparator | Combination Product: Traditional measuresThe patients in this group receive traditional measures perioperatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients elective mediastinal surgery;
- BMI 18-30 kg/m2.
Key exclusion criteria (3 listed)
- Patient refuse;
- ASA≥3;
- Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.
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 |
|---|---|---|
| ERASThe investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery | Combination product | ERAS group |
| Traditional measuresThe investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery | Combination product | Traditional group |
Primary outcome
15-item quality of recovery scale (QoR-15)
Time frame: At preoperative vist
This scale mainly reflects the patient's status
15-item quality of recovery scale (QoR-15)
Time frame: At 24 hours after surgery
This scale mainly reflects the patient's status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERAS and Traditional measures in people with Enhanced Recovery After Surgery, run by Shanghai Zhongshan Hospital 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 2 inclusion and 3 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 5 Sep 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
15-item quality of recovery scale (QoR-15) (time frame: At preoperative vist). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2017.