Clinical application of acupuncture in the treatment of low anterior resection syndrome after rectal cancer surgery
| ISRCTN | ISRCTN12537763 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12537763 |
| Secondary identifying numbers | CFH2022-4-7046 |
- Submission date
- 12/08/2022
- Registration date
- 16/08/2022
- Last edited
- 09/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Low anterior resection syndrome (LARS) is a collection of symptoms that people who have undergone a partial or total resection of the rectum might have. These symptoms include, for example, faecal incontinence or leakage, frequency or urgency of stools, loose stools, incomplete bowel movement, or tenesmus.
Through the patient-reported symptom scale and anorectal pressure test, the effectiveness of acupuncture in the treatment of low anterior resection syndrome for rectal cancer will be preliminarily evaluated, the details of the electroacupuncture intervention plan will be determined, and the onset time will be clarified.
This study will explore the feasibility of acupuncture treatment of low anterior resection syndrome for rectal cancer, and the attitudes, experiences, feelings and acceptance of different patients.
Who can participate?
Patients 18-75 years old who have undergone a partial or total resection of the rectum for cancer treatment.
What does the study involve?
Acupuncture at Baliao point 3 times a week for 4 weeks, a total of 12 times. In addition to acupuncture at Baliao point, the acupoints can be selected according to the patient's syndrome differentiation. For example, Shangjuxu and Xiajuxu will be selected for participants who have received radiotherapy. Also, Baihui and Changqiang will be selected for those who have had diarrhea for a long time.
After completing at least 4 weeks of treatment, 20 patients who are willing to cooperate with the interviews will be selected for semi-structured qualitative interviews.
What are the possible benefits and risks of participating?
Benefit: The patients will receive electroacupuncture treatment and routine blood and urine routine, liver and kidney function, anorectal pressure (needed by some patients) examination for free, and a 300 yuan transportation subsidy will be given to the subjects after completing the trial. It can improve the symptoms of low anterior resection syndrome to some extent, including improvement in unpredictable bowel function, emptying difficulties, altered stool consistency, urgency, increased stool frequency, incontinence, and repeated painful stool soiling.
Potential risks: needle breakage after acupuncture, fainting, local skin infection, bleeding, hematoma, other systemic discomfort after acupuncture, etc.
Where is the study run from?
Third Affiliated Hospital of Beijing University of Chinese Medicine (China)
When is the study starting and how long is it expected to run for?
March 2022 to June 2025
Who is funding the study?
Beijing Municipal Health Commission (China)
Who is the main contact?
Dr Ming Yang
yangming@bucm.edu.cn
Contact information
Scientific
Floor 4,Comprehensive building
No.51, Andingmen Outer Street
Chaoyang District
Beijing
100029
China
 ORCID ID |
0000-0002-2954-7435 |
|---|---|
| Phone | +8613671273351 |
| yangming@bucm.edu.cn |
Study information
| Study design | Mixed methods research including interventional single-arm clinical trial and semi-structured interviews |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Clinical application of acupuncture in the treatment of low anterior resection syndrome after rectal cancer: an exploratory mixed methods research |
| Study acronym | AFLARS |
| Study objectives | To preliminarily evaluate the efficacy and the feasibility of acupuncture in the treatment of low anterior resection syndrome (LARS) for rectal cancer, and try to find a more convenient and effective treatment for LARS. |
| Ethics approval(s) | Approved 22/07/2022, IRB of the Third Hospital Affiliated to Beijing University of Chinese Medicine (no. 51, Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, 100029, China; no telephone number provided; zydsyec@126.com), ref: BZYSY-2022KYKTPJ-07 |
| Health condition(s) or problem(s) studied | Bowel function |
| Intervention | Current interventions, as of 09/05/2023: This study is a mixed method study that includes an interventional single-arm clinical trial and semi-structured interviews. A 30 minutes electroacupuncture intervention at Baliao acupoints (BL31, BL 32, BL 33, BL 34) will be provided to participants three times per week for 4 weeks. Semi-structured interviews will be conducted with 20 participants to understand patients' experience and feelings.The follow-up time points are 1, 3, and 6 months after the end of the 4-week treatment period. ____ Previous interventions: This study is a mixed method study that includes an interventional single-arm clinical trial and semi-structured interviews. A 30 minutes electroacupuncture intervention at Baliao acupoints (BL31, BL 32, BL 33, BL 34) will be provided to participants two times per week for 8 weeks. The follow-up time points are 1, 3, and 6 months after the end of the 8-week treatment period. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measure as of 09/05/2023: Intestinal function is measured using a low anterior resection syndrome (LARS) score at baseline and once a week, 5 times in total. (Low anterior resection syndrome (LARS) scale: refer to LARS scale, scoring the severity of urgency, frequency, clustering, incontinence for flatus and incontinence for liquid stool, 0-20 is classified as no LARS, 21-29 as mild, and 30-42 as severe) ______ Previous primary outcome measure: Intestinal function is measured using a low anterior resection syndrome (LARS) score at baseline and once a week, 9 times in total. (Low anterior resection syndrome (LARS) scale: refer to LARS scale, scoring the severity of urgency, frequency, clustering, incontinence for flatus and incontinence for liquid stool, 0-20 is classified as no LARS, 21-29 as mild, and 30-42 as severe) |
| Secondary outcome measures | Current secondary outcome measures as of 09/05/2023: 1. Intestinal function is measured using an MSKCC Bowel Function Instrument at baseline, and once a week, 5 times in total 2. Bowel functions are measured using anorectal manometry at baseline and after 12 acupuncture treatments 3. Quality of life is measured using an EQ-5D-5L instrument at baseline and every 2 weeks, 3 times in total 4. Quality of life is measured using an EORTC-QLQ-C30 instrument at baseline and every 4 weeks, twice in total _____ Previous secondary outcome measures: 1. Intestinal function is measured using an MSKCC Bowel Function Instrument at baseline, and once a week, 9 times in total 2. Bowel functions are measured using anorectal manometry at baseline and after 16 acupuncture treatments 3. Quality of life is measured using an EQ-5D-5L instrument at baseline and every 2 weeks, 5 times in total 4. Quality of life is measured using an EORTC-QLQ-C30 instrument at baseline and every 4 weeks, 3 times in total |
| Overall study start date | 10/03/2022 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Current inclusion criteria as of 09/05/2023: Patients who are admitted to the outpatient or inpatient Department of Acupuncture, Moxibustion and Minimally Invasive Oncology, The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine, meet the following conditions: 1. Age 18-75 years old 2. Meet the LARS diagnostic criteria, and the LARS score is greater than 20 3. KPS score over 60 points, the expected survival time is more than 3 months 4. Have good communication and understanding skills, and be able to independently report outcome indicators and conduct qualitative interviews 5. Agree to participate in this study and sign the informed consent _____ Previous inclusion criteria: Patients who are admitted to the Outpatient Department of Acupuncture, Moxibustion and Minimally Invasive Oncology, The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine, meet the following conditions: 1. Age 18-75 years old 2. Meet the LARS diagnostic criteria, and the LARS score is greater than 20 3. KPS score over 60 points, the expected survival time is more than 3 months 4. Have good communication and understanding skills, and be able to independently report outcome indicators and conduct qualitative interviews 5. Agree to participate in this study and sign the informed consent |
| Key exclusion criteria | Current exclusion criteria as of 09/05/2023: 1. Those who have a history of other anorectal surgery or trauma affecting bowel movements in the past; those who have a history of spinal cord, brain, and, other nerve damage, who cannot control defecation; those who have experienced serious complications, allergic reactions, or adverse events during acupuncture treatment in the past, who cannot cooperate or refuse to Those who tolerate acupuncture treatment 2. Patients with other intestinal or anorectal diseases; patients with postoperative complications such as anastomotic leakage, anastomotic bleeding, anastomotic stenosis, and intestinal puncture 3. Those who are receiving other acupuncture treatments 4. Sacral deformity caused by any reason, those who cannot accurately locate the acupoints 5. Patients with serious primary diseases such as cardiovascular, liver, kidney, and hematopoietic system and mental illness; 6. Participating in other clinical investigators _____ Previous exclusion criteria: 1. Those who have a history of other anorectal surgery or trauma in the past; those who have a history of spinal cord, brain, and, other nerve damage, who cannot control defecation; those who have experienced serious complications, allergic reactions, or adverse events during acupuncture treatment in the past, who cannot cooperate or refuse to Those who tolerate acupuncture treatment 2. Patients with other intestinal or anorectal diseases; patients with postoperative complications such as anastomotic leakage, anastomotic bleeding, anastomotic stenosis, and intestinal puncture 3. Those who are receiving other acupuncture treatments 4. Sacral deformity caused by any reason, those who cannot accurately locate the acupoints 5. Patients with serious primary diseases such as cardiovascular, liver, kidney, and hematopoietic system and mental illness; 6. Participating in other clinical investigators |
| Date of first enrolment | 10/03/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
No.51, Andingmen Outer Street
Chaoyang District
Beijing
100029
China
Sponsor information
Hospital/treatment centre
No. 51, Xiaoguan Street
Andingmenwai
Chaoyang District
Beijing
100029
China
| Phone | +86 10-84980751 |
|---|---|
| zydsyec@126.com | |
| Website | http://wjw.beijing.gov.cn |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- 北京市卫生健康委员会, Beijing Municipal Bureau of Health, Commission municipale de la Santé de Beijing, BMHB
- Location
- China
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact journal. |
| IPD sharing plan | The participant-level data will not be available as it is not covered in the informed consent for participants. The research data will apply the Research Electronic Data Capture (REDCap) for data collection and management. |
Editorial Notes
09/05/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 22/08/2022 to 10/03/2023.
2. The recruitment end date was changed from 22/06/2024 to 31/12/2024.
3. The overall start date was changed from 22/07/2022 to 10/03/2022.
4. The overall end date was changed from 31/12/2024 to 30/06/2025.
5. The intention to publish date was changed from 01/12/2024 to 01/12/2025.
6. The interventions were changed.
7. The primary outcome measure was changed.
8. The secondary outcome measures were changed.
9. The inclusion criteria were changed.
10. The exclusion criteria were changed.
11. The plain English summary was updated to reflect these changes.
15/08/2022: Trial's existence confirmed by the IRB of the Third Hospital Affiliated to Beijing University of Chinese Medicine.
