Postoperative RecoveryARCONCT02921529
TEAS Enhanced Recovery After Laparoscopic Colon Surgery
A study testing TEAS and false stimulation in people with Postoperative Recovery, run by Zhihong LU at 3 sites in China.
Trial summary
The purpose of this study is to observe the effects of transcutaneous electrical acupoint stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Recovery
- What is being tested?
- TEAS and false stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2016to Apr 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 75 years old；
- ASA I-III；
- Scheduled for elective laparoscopic colon surgery under general anesthesia；
- BMI between 18 and 30；
- Informed consented.
Who cannot join
- Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints；
- Patients with difficulty in communication；
- Emergency surgery；
- Patients who are with distant metastasis;
- Patients who are with history of myocardial infarction or cerebral infarction in the past six months；
- Patients who are with long history of taking NSAIDS，hormone or immunosuppressive agents；
- Patients who are recruited in other clinical trials in the last 3 months；
- Other situations researcher think shouldn't be included.
Trial locations and contacts
3 sites in 1 country.
China3 sites
First Afiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Tongji Hospital
Wuhan, Hubei
Xijing Hospital
Xi'an, Shaanxi, 710032
About this study
Official title: Perioperative Transcutaneous Electrical Acupoint Stimulation for Enhanced Recovery After Laparoscopic Colon Surgery:a Multi-center Randomized Controlled Clinical Trial
The purpose of this study is to observe the effects of transcutaneous electrical acupoint stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery.
Read the detailed description
Patients were randomly assigned to two groups, receiving TEAS andno stimulation respectively. Interventions were given 30min before anesthesia and 1, 2 , 3 day after surgery, lasted 30min each time . The acupoints of TEAS group are bilateral ST36/SP6 combined with PC6/LI4, and the control group only attach electrodes without electric current. The frequency of TEAS is set to 2/10 Hz. After surgery, the time of meeting discharge criteria, first flatus and defecation were recorded. Score of PONV, life quality, sleep quality and VAS of pain were evaluated 24, 48 and 72h after surgery. The postoperative complications, re-exploration, cost of hospitalization and adverse events were also recorded.
- Conditions
- Postoperative Recovery
- Being tested
- TEAS, false stimulation
- Keywords
- Postoperative recovery, colon surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASOther
Also called Acupuncture, Electric stimulation
Electric stimulation was given through electrode attached to specific acupoints
false stimulationOther
Also called sham stimulation
Electrodes were attached to specific acupoints without electric current
| Study group | Role | What they receive |
|---|---|---|
| TEAS | Experimental | Patients were given 30min of TEAS(transcutaneous electrical acupoint stimulation) before anesthesia and 1,2,3 day after surgery Receives: Other: TEAS |
| false stimulation | Sham comparator | Attach electrodes without electric current Receives: Other: false stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to meeting discharge criteria
Measured: end of the surgery to discharge,with an average of 7 days
Secondary outcomes (9)
Time to first flatus
Measured: end of the surgery to discharge,with an average of 7 days
Time to first defecation
Measured: end of the surgery to discharge,with an average of 7 days
Incidence of postoperative complications
Measured: end of the surgery to discharge,with an average of 7 days
Time to first oral intake of water
Measured: end of the surgery to discharge,with an average of 7 days
visual analogue scale
0 is for no pain, 10 is for pain that can not be tolerated
Measured: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
incidence of nausea and vomiting
Measured: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
quality of sleeping score
0 is for totally insomnia, 10 is for perfect sleep
Measured: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
quality of recovery
using a questionaire including 15 items that covering postoperative recovery
Measured: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
expense
patients' cost after surgery
Measured: end of the surgery to discharge,with an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative RecoveryStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921529
- Sponsor's protocol ID
- XJH-A-2016-09-01
- Acronym
- ARCO
- Status last verified
- Jun 2018
- First submitted
- 28 Sep 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Transcutaneous Electrical Acupoint Stimulation for Enhanced Recovery After Laparoscopic Colon Surgery:a Multi-center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02921529
- Acronym / sponsor ID
- ARCO / XJH-A-2016-09-01
- Conditions
- Postoperative Recovery
- Keywords
- Postoperative recovery, colon surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 3 Oct 2016 (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 observe the effects of transcutaneous electrical acupoint stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery.
Detailed description
Patients were randomly assigned to two groups, receiving TEAS andno stimulation respectively. Interventions were given 30min before anesthesia and 1, 2 , 3 day after surgery, lasted 30min each time . The acupoints of TEAS group are bilateral ST36/SP6 combined with PC6/LI4, and the control group only attach electrodes without electric current. The frequency of TEAS is set to 2/10 Hz. After surgery, the time of meeting discharge criteria, first flatus and defecation were recorded. Score of PONV, life quality, sleep quality and VAS of pain were evaluated 24, 48 and 72h after surgery. The postoperative complications, re-exploration, cost of hospitalization and adverse events were also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS | Experimental | Other: TEASPatients were given 30min of TEAS(transcutaneous electrical acupoint stimulation) before anesthesia and 1,2,3 day after surgery |
| false stimulation | Sham comparator | Other: false stimulationAttach electrodes without electric current |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 to 75 years old；
- ASA I-III；
- Scheduled for elective laparoscopic colon surgery under general anesthesia；
- BMI between 18 and 30；
- Informed consented.
Key exclusion criteria (8 listed)
- Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints；
- Patients with difficulty in communication；
- Emergency surgery；
- Patients who are with distant metastasis;
- Patients who are with history of myocardial infarction or cerebral infarction in the past six months；
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 |
|---|---|---|
| TEASAlso: Acupuncture, Electric stimulationElectric stimulation was given through electrode attached to specific acupoints | Other | TEAS |
| false stimulationAlso: sham stimulationElectrodes were attached to specific acupoints without electric current | Other | false stimulation |
Primary outcome
Time to meeting discharge criteria
Time frame: end of the surgery to discharge,with an average of 7 days
9 secondary outcomes
Time to first flatus
Time frame: end of the surgery to discharge,with an average of 7 days
Time to first defecation
Time frame: end of the surgery to discharge,with an average of 7 days
Incidence of postoperative complications
Time frame: end of the surgery to discharge,with an average of 7 days
Time to first oral intake of water
Time frame: end of the surgery to discharge,with an average of 7 days
visual analogue scale
Time frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
incidence of nausea and vomiting
Time frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
quality of sleeping score
Time frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
quality of recovery
Time frame: end of surgery to 24 hours, 48 hours, and 72 hours after surgery
expense
Time frame: end of the surgery to discharge,with an average of 7 days
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 6 Jun 2018.
- Individual participant dataSharing planned: Yes
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS and false stimulation in people with Postoperative Recovery, run by Zhihong LU at 3 sites 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 5 inclusion and 8 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Time to meeting discharge criteria (time frame: end of the surgery to discharge,with an average of 7 days). 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 6 Jun 2018.