Rectal Cancer
Conditions
Keywords
ERAS, Integrative medicine, Acupoint application, Compliance, Quality of life
Brief summary
This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
Detailed description
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.
Interventions
COMBINATION_PRODUCTacupoint with TCM
The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.
COMBINATION_PRODUCTacupoint with placebo
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.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Patients enrolled are randomized into acupoint application group and placebo acupoint application group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | from operation to 30 days after operation | Rates of the complications after curative surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recovery of urinary function | from removal of urinary catheter to 30 days after operation | The rates of urinary retention after removal of urinary catheter |
| Recovery of fart and bowel function | 7 days after operation | The time of the first tart and first defecation after operation in days |
| The European Organization of Quality of Life Questionnaire-colorectal-29 | 30 days after operation | Cancer Quality of Life Questionnaire-Colorectal-29, with scale from 1 to 4 for each items as QOL becomes poorer. |
| Changes of TCM symptoms | 30 days after operation | 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. |
| Length of hospital stay | 30 days after operation | Time of hospital stay in days |
Countries
China
Contacts
Primary ContactNan Chen, M.D.;Ph.D
Outcome results
None listed