Bowel function Digestive System
Conditions
Interventions
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
Sponsors
Third Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Outcome results
None listed