Postoperative Intestinal ObstructionTAESRIOGSNCT03086304
Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery
A study testing transcutaneous acupoint electrical stimulation and no transcutaneous acupoint electrical stimulation in people with Postoperative Intestinal Obstruction, run by First Affiliated Hospital Xi'an Jiaotong University at 10 sites in China.
Trial summary
Postoperative intestinal obstruction (POI) is one of the most common complications in the gastrointestinal surgery. Compared with the conventional control group, transcutaneous acupoint electrical stimulation(TEAS) is possible to reduce the incidence of POI and accelerate the rapid recovery of the gastrointestinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Intestinal Obstruction
- What is being tested?
- transcutaneous acupoint electrical stimulation and no transcutaneous acupoint electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 10 sitesChina
- Study dates
- 28 May 2018to 30 Sep 2019
- 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
- All the patients signed the informed consent before treatment;
- Age ≥ 18 years old,American society of Anesthesiologists(ASA)grade are between I and III;
- Plan to perform elective colon and rectal tumor resection under general anesthesia;
- not involved in other clinical studies;
- no cognitive impairment, mental disorders,communication disorders.
Who cannot join
- Pregnancy, breast-feeding;
- The history of intestinal surgery;
- Test point skin injury, infection, allergies to tape;
- have undergone external enterostomy;
- Chief surgeon refuse to cooperate.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Ankang Central Hospital
Ankang, Shaanxi, 029725000
Ankang Hospital of Traditional Chinese Medicine
Ankang, Shaanxi, 029725000
Weinan Central Hospital
Weinan, Shaanxi, 029714000
Xi'an Central Hospital
Xi'an, Shaanxi, 029710003
Xi'an Hospital of traditional Chinese Medicine
Xi'an, Shaanxi, 029710021
Central Railway Group of Xi'an Central Hospital
Xi'an, Shaanxi, 029710054
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 029710061
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 029710068
Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
Xianyang, Shaanxi, 029712000
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, 029716000
About this study
Official title: Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery in Adults
Postoperative intestinal obstruction (POI) is one of the most common complications in the gastrointestinal surgery. Compared with the conventional control group, transcutaneous acupoint electrical stimulation(TEAS) is possible to reduce the incidence of POI and accelerate the rapid recovery of the gastrointestinal tract.
Read the detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive TEAS or Blank treatment (acupoints selection are same with the experimental group, connect stimulator for patients, but not don't give stimulus). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. TEAS will be performed in a series of time periods after operation. Time of first fart and food-taking ,time of have normal diet after the transplantation will be recorded. The participation of each patient is scheduled for 30 days.
- Conditions
- Postoperative Intestinal Obstruction
- Being tested
- transcutaneous acupoint electrical stimulation, no transcutaneous acupoint electrical stimulation
- Keywords
- postoperative intestinal obstruction;TEAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous acupoint electrical stimulationDevice
Transcutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points.
no transcutaneous acupoint electrical stimulationDevice
the choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | Choose several acupoints,give 2/10 hz dilatational wave stimulation.Complete the 30 minutes intervention after extubation and 1-3 days after surgery.Give a health education on the first postoperative day. Receives: Device: transcutaneous acupoint electrical stimulation |
| no TEAS group | Experimental | The choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation,the others steps are same with TEAS group. Receives: Device: no transcutaneous acupoint electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POI
Whether or not to exhaust in 72 hours after surgery
Measured: 72 hours after surgery
Secondary outcomes (5)
postoperative gastrointestinal function recovery
the time of postoperative exhaustion and defecation.
Measured: once a week for 30 days after surgery
recovery of bowel sounds
the recovery time of bowel sounds
Measured: 1-3 days after surgery
adverse reactions of digestive after surgery
the incidence and score of distention, abdominal pain, nausea and vomiting after surgery.
Measured: 1-3 days after surgery
surgery complications
wound infection ,pneumonia, anastomotic leakage,urethritis,uroschesis
Measured: once a week for 30 days after surgery
recovery index
the leaving bed time,normal diet recovery time,post-operative hospitalization duration
Measured: once a week for 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 Mar 2017
- Study start28 May 2018
- Primary completion3 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, Xi'an Central Hospital, Ankang Hospital of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Ankang Central Hospital, Weinan Central Hospital, Central Railway Group of Xi'an Central Hospital, Xi'an Hospital of Traditional Chinese Medicine, Yan'an University Affiliated Hospital
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, PHD, Study chair, First Affiliated Hospital of Xian JiaotongUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086304
- Sponsor's protocol ID
- XJTU1AF-CRF-2016-003
- Acronym
- TAESRIOGS
- Status last verified
- Nov 2019
- First submitted
- 3 Mar 2017
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Acupoint Electrical Stimulation on Intestinal Obstruction After Gastrointestinal Surgery in Adults
- ClinicalTrials.gov ID
- NCT03086304
- Acronym / sponsor ID
- TAESRIOGS / XJTU1AF-CRF-2016-003
- Conditions
- Postoperative Intestinal Obstruction
- Keywords
- postoperative intestinal obstruction;TEAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Shaanxi Provincial People's Hospital, Xi'an Central Hospital, Ankang Hospital of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Ankang Central Hospital, Weinan Central Hospital, Central Railway Group of Xi'an Central Hospital, Xi'an Hospital of Traditional Chinese Medicine, Yan'an University Affiliated Hospital
- Study start
- 28 May 2018 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 22 Mar 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.
Postoperative intestinal obstruction (POI) is one of the most common complications in the gastrointestinal surgery. Compared with the conventional control group, transcutaneous acupoint electrical stimulation(TEAS) is possible to reduce the incidence of POI and accelerate the rapid recovery of the gastrointestinal tract.
Detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive TEAS or Blank treatment (acupoints selection are same with the experimental group, connect stimulator for patients, but not don't give stimulus). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. TEAS will be performed in a series of time periods after operation. Time of first fart and food-taking ,time of have normal diet after the transplantation will be recorded. The participation of each patient is scheduled for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: transcutaneous acupoint electrical stimulationChoose several acupoints,give 2/10 hz dilatational wave stimulation.Complete the 30 minutes intervention after extubation and 1-3 days after surgery.Give a health education on the first postoperative day. |
| no TEAS group | Experimental | Device: no transcutaneous acupoint electrical stimulationThe choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation,the others steps are same with TEAS group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All the patients signed the informed consent before treatment;
- Age ≥ 18 years old,American society of Anesthesiologists(ASA)grade are between I and III;
- Plan to perform elective colon and rectal tumor resection under general anesthesia;
- not involved in other clinical studies;
- no cognitive impairment, mental disorders,communication disorders.
Key exclusion criteria (5 listed)
- Pregnancy, breast-feeding;
- The history of intestinal surgery;
- Test point skin injury, infection, allergies to tape;
- have undergone external enterostomy;
- Chief surgeon refuse to cooperate.
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 |
|---|---|---|
| transcutaneous acupoint electrical stimulationTranscutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points. | Device | TEAS group |
| no transcutaneous acupoint electrical stimulationthe choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation. | Device | no TEAS group |
Primary outcome
Incidence of POI
Time frame: 72 hours after surgery
Whether or not to exhaust in 72 hours after surgery
5 secondary outcomes
postoperative gastrointestinal function recovery
Time frame: once a week for 30 days after surgery
recovery of bowel sounds
Time frame: 1-3 days after surgery
adverse reactions of digestive after surgery
Time frame: 1-3 days after surgery
surgery complications
Time frame: once a week for 30 days after surgery
recovery index
Time frame: once a week for 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 19 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Intestinal Obstruction
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Recruiting
The Food Network Effect
Post Operative Patients
Not yet recruiting
Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery
Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief
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.
Qiang Wang, PHD study chair
First Affiliated Hospital of Xian JiaotongUniversity
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous acupoint electrical stimulation and no transcutaneous acupoint electrical stimulation in people with Postoperative Intestinal Obstruction, run by First Affiliated Hospital Xi'an Jiaotong University at 10 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 5 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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?
Incidence of POI (time frame: 72 hours after surgery). 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 19 Nov 2019.