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This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM group | Experimental | Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine. |
|
| Control group | Placebo Comparator | Rectal cancer patients randomized to this group will have acupoint application with placebo . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupoint with TCM | Combination Product | The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Rates of the complications after curative surgery | from operation to 30 days after operation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Chen, M.D.;Ph.D | Contact | +86 18911956939 | chennanpku@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Aiwen Wu, M.D. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Xiaoqiang Jia, M.D.;Ph.D | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D015669 | Acupuncture Points |
| ID | Term |
|---|---|
| D016740 | Meridians |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Patients enrolled are randomized into acupoint application group and placebo acupoint application group
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| acupoint with placebo | Combination Product | 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. |
|
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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |