Does electroacupuncture reduce gut problems in patients treated with pain-relieving drugs after keyhole surgery to the lower bowel?
| ISRCTN | ISRCTN13146325 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13146325 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/04/2018
- Registration date
- 10/05/2018
- Last edited
- 08/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Bowel problems, abdominal pain and wound pain are common after-effects of laparoscopic (keyhole) surgery to the colon or rectum (lower part of the intestine). This can be a result of organs being pulled or squeezed during surgery, blood leakage and/or the use of anesthetics and other drugs. Recovery of normal gut function after abdominal surgery is an important part of the recovery period. Acupuncture has been identified as an effective method for the recovery of intestinal function. This study aims to recruit 160 patients to compare electroacupuncture treatment and conventional (usual) treatment to prevent gut problems after keyhole surgery of the colon and rectum.
Who can participate?
People at the age of 30-80 years old who undergo laparoscopic surgery to the colon or rectum.
What does the study involve?
Participants are randomly allocated to electroacupuncture group and conventional group. In the electroacupuncture group, they take electroacupuncture treatment as well as conventional treatment. In the conventional group, they accept conventional treatment alone.
What are the possible benefits and risks of participating?
All participants receive conventional treatment and the participants in intervention group additionally accept electroacupuncture treatment for free. Information obtained from this research might help patients in the future. By taking part in this study there are no risks of physical injury or harm.
Where is the study run from?
Guang' anmen Hospital and Xiyuan hospital, China Academy of Chinese Medical Sciences
When is the study starting and how long is it expected to run for?
March 2018 to December 2021
Who is funding the study?
The Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences (China)
Who is the main contact?
Dr Mingyue Gao
gmyaaa@126.com
Contact information
Scientific
16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing, China
Beijing
100700
China
Study information
| Study design | A prospective, randomized controlled and single blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | To observe the effect of gastrointestinal dysfunction in electroacupuncture versus conventional treatment for the patients with laparoscopic colorectal surgery |
| Study objectives | Electroacupuncture and conventional treatments might be superior to individual conventional treatment . |
| Ethics approval(s) | Ethics board of the Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, 18/01/2018, 2017-12-25-1-2 |
| Health condition(s) or problem(s) studied | Gastrointestinal dysfunction and intestinal infection are common symptoms after laparoscopic colorectal surgery, which will affect the operation effect and prolong postoperative recovery time. |
| Intervention | Intervention arm: Electroacupuncture combined with conventional treatment, which included 80 participants Control arm: Conventional treatment, which included 80 participants Electroacupuncture treatment group: Patients in the electroacupuncture group receive acupuncture with electrostimulation with stainless steel needles and a Hwato SDZ-II electroacupuncture device after surgery. After standard disinfection of the acupoints with 75% ethanol solution, the acupuncturist will position the disposable medical needles (0.30 mm diameter x 1.5 mm length) perpendicular to the skin at the subject’s acupoints and then needle them into the skin. Electroacupuncture is given for 30 minutes, once a day, starting 24 hours after surgery and lasting for 7 days. Acupoints are the following, which are known to promote gastrointestinal motility: ST36 (Zusanli), ST37 (Shangjuxu), LI4 (Hegu), LR3 (Taichong). After standard disinfection of the acupoints with 75% ethanol solution, the acupuncturist will position the disposable medical needles (0.30 mm diameter × 1.5 mm length) perpendicular to the skin at the subject’s acupoints and then needle them into the skin. Patients in conventional treatment group receive routine intravenous nutrition lasts for the patients discharge from hospital and analgesic pump lasts 3 days after surgery. Conventional treatment group: Routine intravenous nutrition lasts for the subjects out of hospital. The randomisation process: Patients will be assigned in a 1:1 ratio to either the electroacupuncture group or the conventional group using random numbers generated in EXCEL. The random numbers will be concealed inside sealed, opaque, serialized envelopes and only one assigned investigator can open them. When recruiters identify a subject who meets the criteria for participation, they will obtain a sequence number for that subject from the researcher in charge of the randomization numbers. Statisticians will be unaware of the group assignment. When the patients have incisional pain/abdominal pain, an analgesic pump will be used. According to the degree of pain and if the VAS score greater than 6 points, they can self-control the button of pump for pain relief. Flurbiprofen axetil Injection is administered intravenously at 50 mg at times when the pain is unbearable after 30 minutes of the analgesic pump being controlled by the patient. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to first flatus and defecation |
| Secondary outcome measures | 1. VAS score of postoperative incisional pain and abdominal pain 24 h, 2 days and 3 days after surgery 2. Quality of life: We will use the postoperative recovery quality score to evaluate the participants’ quality of life. 3. Hospital days |
| Overall study start date | 01/03/2018 |
| Completion date | 30/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 160 |
| Key inclusion criteria | Participant inclusion criteria as of 19/11/2018: 1. Participants must be aged 30–80 years; 2. The evaluation function of elderly mental state scale (MMSE) ≥ 27 points; 3. Colonic and rectal diseases have been diagnosed and colorectal cancer is not diffuse 4. TNM stage is less than stage 3; 5. Participants who have undergone laparoscopy; 6. Participants with colon or rectum disease who have undergone a laparotomy; 7. The ASA level of the American anesthesiologist is I-II; 8. Nutritional risk screening confirmed that NRS 2002 score ≥ 3 points in patients before operation; 9. Participants have signed informed consent. Previous participant inclusion criteria: 1. Participants must be aged 30–80 years; 2. The evaluation function of elderly mental state scale (MMSE) ≥ 27 points; 3. Colonic and rectal diseases have been diagnosed and colorectal cancer is not diffuse 4. TNM stage is less than stage 3; 5. Participants who have been treated by laparoscopy; 6. The ASA level of the American anesthesiologist is I-II; 7. Nutritional risk screening confirmed that NRS 2002 score ≥ 3 points in patients before operation; 8. Participants have signed informed consent. |
| Key exclusion criteria | 1. People who take sedatives and antidepressants for a long time; 2. People treated with acupuncture for nearly a month; 3. People with a history of abdominal surgery in the last three months; 4. People with mental disorders or difficulties in language communication can not finish the research; 5. People who can not receive electroacupuncture treatment. |
| Date of first enrolment | 01/04/2018 |
| Date of final enrolment | 30/07/2021 |
Locations
Countries of recruitment
- China
Study participating centres
China
China
Sponsor information
Not defined
16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing, China
Beijing
100700
China
"ROR" |
https://ror.org/042pgcv68 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan |
Editorial Notes
08/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/12/2020 to 30/07/2021.
2. The overall trial end date has been changed from 30/12/2020 to 30/12/2021.
3. The intention to publish date has been changed 30/05/2021 to 30/04/2022.
07/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 01/12/2019 to 01/12/2020.
2. The overall trial end date has been changed from 30/12/2019 to 30/12/2020.
3. The intention to publish date has been changed from 30/12/2020 to 30/05/2021.
19/11/2018: The participant inclusion criteria was updated.
