The Role of TCM on ERAS of Rectal Cancer Patients

Study Overview
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Brief Summary
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This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.

Detailed Description
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The hypothesis is that TCM can decrease the postoperative complications for rectal cancer. So the study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients. Patients enrolled in this study will be randomized into two groups with TCM intervention or placebo. The intervention will be described below. Primary endpoint is postoperative complications.

Official Title
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The Role of Traditional Chinese Medicine on Enhanced Recovery After Surgery for Patients With Rectal Cancer Undergoing Curative Surgery: A Randomized Controlled Trial

Conditions
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Rectal Cancer

Intervention / Treatment
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* Combination Product: acupoint with TCM
* Combination Product: acupoint with placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written consent form; Age from 18 to 75 years old; Pathological diagnosis as rectal adenocarcinoma; undergo laparoscopic curative surgery; Patients' TCM syndrome accords with thoses of spleen deficiency syndrome; Exclusion Criteria: Patients undergo non-curative surgeries; Participants with skin allergy, skin ulceration and diabetes mellitus with poor glycemic control; Participants with severe dysfunction of heart, liver and kidney, who could not receive TCM treatment; Women who are pregnant or breastfeeding; Participants have mental illness or have difficulty in language communication and are unable to complete the study; Participants could not cooperate with this researcher for other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients enrolled are randomized into acupoint application group and placebo acupoint application group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM group<br>Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine. | Combination Product: acupoint with TCM<br>* The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.<br>|
| Placebo Comparator: Control group<br>Rectal cancer patients randomized to this group will have acupoint application with placebo . | Combination Product: acupoint with placebo<br>* The placebo acupoint application was made of black beans and honey, which shares the similar shape and smell of the experiment group, applied at the same acupoints.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Rates of the complications after curative surgery | from operation to 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery of urinary function | The rates of urinary retention after removal of urinary catheter | from removal of urinary catheter to 30 days after operation | 
| Recovery of fart and bowel function | The time of the first tart and first defecation after operation in days | 7 days after operation | 
| The European Organization of Quality of Life Questionnaire-colorectal-29 | Cancer Quality of Life Questionnaire-Colorectal-29, with scale from 1 to 4 for each items as QOL becomes poorer. | 30 days after operation | 
| Changes of TCM symptoms | Changes of traditional Chinese medicine symptoms: all symptoms were recorded by 10 simple questions and then will be categorized in 4 different groups. The aim of study tries to show the relationship with TCM application with the symptoms. | 30 days after operation | 
| Length of hospital stay | Time of hospital stay in days | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Integrative medicine, Acupoint application, Compliance, Quality of life