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Clinical application of acupuncture in the treatment of low anterior resection syndrome after rectal cancer surgery

Not Applicable
Conditions
Bowel function
Digestive System
Registration Number
ISRCTN12537763
Lead Sponsor
Third Hospital Affiliated to Beijing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
60
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Current primary outcome measure as of 09/05/2023: <br><br>Intestinal function is measured using a low anterior resection syndrome (LARS) score at baseline and once a week, 5 times in total.<br>(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)<br><br>______<br><br>Previous primary outcome measure:<br><br>Intestinal function is measured using a low anterior resection syndrome (LARS) score at baseline and once a week, 9 times in total.<br>(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
NameTimeMethod
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