Postoperative IleusNCT04008667
The Effect of Acupoint Application on Postoperative Ileus
A study testing Acupoint application and Fake acupoint application in people with Postoperative Ileus, run by li xiong at 1 site in China.
Trial summary
This study aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Acupoint application and Fake acupoint application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- Jul 2019to Jul 2021
- 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
- 1. Patients are scheduled to undergo elective abdominal surgery;
- 2. Patients age between 20 to 80 years old;
- 3. Umbilical skin condition is good;
- 4. Written informed consent provided to participate in the study.
Who cannot join
- 1.Patients don't match the inclusion criteria;
- 2. Patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ;
- 3.Patients with mental disorder;
- 4. Patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc;
- 5. Patients received ostomy operation, such as jejunostomy;
- 6.Patients who have history of abdominal surgery or history of bowel obstruction;
Show all 9Show fewer
- 7. Patients who receive other treatments to improve the gastrointestinal mobility or/and to relieve POI related symptoms , such as gastrointestinal prokinetic drugs, enema, etc.
- 8. Patients who are allergic to the acupoint applicaton;
- 9.Patients who are unsuitable for study inclusion as determined by the investigator. (eg: patients with severe operation related complications)
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410016
Xiong Li, M.D, lixionghn@163.com
About this study
Official title: The Effect of Acupoint Application on Postoperative Ileus: a Randomized Controlled Trial
This study aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.
Read the detailed description
Postoperative ileus (POI) is a common disorder of gastrointestinal motility characterized by abdominal distension, nausea, vomiting and delayed passage of flatus or stool, which develops after every abdominal surgical procedure. POI increases risk of developing postoperative complications, decreases the bed turnover rate and prolongs the average duration of hospitalization, increasing the expense of both patients and hospitals. Although the Pathophysiological mechanism of POI remains unclear, recent researches suggests the inflammatory responses after surgery might be responsible for the gastrointestinal motility disorder. Acupoint application is a traditional chinese intervention which has been used in treating gastrointestinal motility disorder resulted from other causes. In this study, we aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.
- Conditions
- Postoperative Ileus
- Being tested
- Acupoint application, Fake acupoint application
- Keywords
- Postoperative ileus, acupoint, ERAS, Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupoint applicationOther
Acupoint application: The patients start using the acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
Fake acupoint applicationOther
Fake acupoint application: The patients start using the fake acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Receiving the acupoint application and optimal supports.
The patients start using the acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc. Receives: Other: Acupoint application |
| Placebo arm | Placebo comparator | Receiving the fake acupoint application and optimal supports.
The fake acupoint is
The patients start using the fake acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc. Receives: Other: Fake acupoint application |
| Control arm | No intervention | Receiving the optimal supports. All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to defecate and tolerate for food (TF+D)
Defined as the first time that the patient could both defecate and tolerate orally taking food after surgery.
Measured: End of surgery to time to defecate and tolerate for food(from 5 to 7 days)
Secondary outcomes (4)
time to return of bowel sounds
Defined as the first time hear the bowel sound after surgery.
Measured: End of surgery to the first bowel sound (from 1 to 5 days)
time to report of first flatus
Defined as the first time flatus happens.
Measured: End of surgery to the first flatus (from 1 to 5 days)
time to report of first defecation
Defined as the first time defecation happens.
Measured: End of surgery to the first defecation. (from 1 to 7 days)
length of postoperative hospitalization
Defined as the length hospitalization after surgery
Measured: End of surgery to hospital discharge. (from 5 to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies 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
- Model description
- Intervention arm：receiving acupoint application and regular therapy; Placebo arm: receiving fake acupoint application and regular therapy; control arm: receiving regular therapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- li xiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, li xiong, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008667
- Sponsor's protocol ID
- lxiong
- Status last verified
- Jul 2019
- First submitted
- 29 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupoint Application on Postoperative Ileus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04008667
- Acronym / sponsor ID
- lxiong
- Conditions
- Postoperative Ileus
- Keywords
- Postoperative ileus, acupoint, ERAS, Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- li xiongUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 5 Jul 2019 (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 study aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.
Detailed description
Postoperative ileus (POI) is a common disorder of gastrointestinal motility characterized by abdominal distension, nausea, vomiting and delayed passage of flatus or stool, which develops after every abdominal surgical procedure. POI increases risk of developing postoperative complications, decreases the bed turnover rate and prolongs the average duration of hospitalization, increasing the expense of both patients and hospitals. Although the Pathophysiological mechanism of POI remains unclear, recent researches suggests the inflammatory responses after surgery might be responsible for the gastrointestinal motility disorder. Acupoint application is a traditional chinese intervention which has been used in treating gastrointestinal motility disorder resulted from other causes. In this study, we aims to verify the therapeutical effect and mechanism of acupoint application on postoperative ileus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Intervention arm：receiving acupoint application and regular therapy; Placebo arm: receiving fake acupoint application and regular therapy; control arm: receiving regular therapy.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Acupoint applicationReceiving the acupoint application and optimal supports. The patients start using the acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days. All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc. |
| Placebo arm | Placebo comparator | Other: Fake acupoint applicationReceiving the fake acupoint application and optimal supports. The fake acupoint is The patients start using the fake acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days. All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc. |
| Control arm | No intervention | –Receiving the optimal supports. All patients will receive optimal supports during the observation period, including preoperative gastrointestinal preparation, inserting gastric tube, postoperative fasting, necessary antibiotic use, rational fluid management, detaining drainage tube, etc. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients are scheduled to undergo elective abdominal surgery;
- 2. Patients age between 20 to 80 years old;
- 3. Umbilical skin condition is good;
- 4. Written informed consent provided to participate in the study.
Key exclusion criteria (9 listed)
- 1.Patients don't match the inclusion criteria;
- 2. Patients with severe comorbidity such as cardiac disease, liver disease, pulmonary disease or renal disease ;
- 3.Patients with mental disorder;
- 4. Patients have gastrointestinal mobility disorder resulted from clear causes, such as ankylenteron, ascites, etc;
- 5. Patients received ostomy operation, such as jejunostomy;
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 |
|---|---|---|
| Acupoint applicationAcupoint application: The patients start using the acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days. | Other | Intervention arm |
| Fake acupoint applicationFake acupoint application: The patients start using the fake acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days. | Other | Placebo arm |
Primary outcome
time to defecate and tolerate for food (TF+D)
Time frame: End of surgery to time to defecate and tolerate for food(from 5 to 7 days)
Defined as the first time that the patient could both defecate and tolerate orally taking food after surgery.
4 secondary outcomes
time to return of bowel sounds
Time frame: End of surgery to the first bowel sound (from 1 to 5 days)
time to report of first flatus
Time frame: End of surgery to the first flatus (from 1 to 5 days)
time to report of first defecation
Time frame: End of surgery to the first defecation. (from 1 to 7 days)
length of postoperative hospitalization
Time frame: End of surgery to hospital discharge. (from 5 to 7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Postoperative Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
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 study testing Acupoint application and Fake acupoint application in people with Postoperative Ileus, run by li xiong 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 4 inclusion and 9 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 Jul 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiong Li, M.D (+86-13787782059, lixionghn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to defecate and tolerate for food (TF+D) (time frame: End of surgery to time to defecate and tolerate for food(from 5 to 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 5 Jul 2019.