Colorectal Cancer
Conditions
Keywords
acupressure, postoperative ileus
Brief summary
The goal of this clinical trial is to learn about acupressure in patients with colorectal cancer surgery. The main questions it aims to answer are: * whether acupressure can improve the motility of vagus nerve in patients after colorectal cancer surgery * whether acupressure can reduce the inflammatory response of the body * whether acupressure can reduce the incidence of gastrointestinal paralysis in patients after colorectal cancer surgery Participants will receive acupressure at ST36 twice daily starting from the first day after surgery and lasting for five days. Researchers will compare usual care group to see if acupressure has those above effects.
Detailed description
2\. Purpose of the study 2.1 Main research objectives: To improve the gastrointestinal function of patients with colorectal cancer after surgery, with the design and implementation of acupressure as the intervention. Through clinical research, the effectiveness of acupressure in improving gastrointestinal function in patients with colorectal cancer surgery will be discussed, and the regulatory effect of acupressure on sympathetic and vagus nerves will be further revealed, and the mechanism affecting gastrointestinal function will be explored from the perspective of nerve and inflammatory response. 2.2 Secondary Research Objectives and Exploratory Research Objectives: 1. To shorten the length of hospital stay, and save medical resources in patients with colorectal cancer surgery; 2. To reveal the mechanism of acupressure, focusing on autonomic regulation and inflammatory response; 3. To explore the association of autonomic regulation with self-reported anxiety, depression, and stress. 3\. Study plan 3.1 Design of experiments 1. Investigate the general data and perioperative data of colorectal cancer surgery patients Investigators will independently design the questionnaire, including the following aspects: (1) general information: gender, age, height, weight, previous abdominal surgery history, preoperative radiotherapy and chemotherapy history, underlying diseases, etc.; (2) surgical conditions: surgical method, anesthesia method, duration of surgery, duration of anesthesia, intraoperative heat preservation measures and liquid input, etc.; (3) diet: drinking water, liquid diet, soft diet, ordinary diet time, etc.; (4) exercise: first time out of bed after surgery, etc.; (5) medication: antiemetics, Intramuscular analgesics, etc. 2. Design and implementation of acupressure intervention program On the basis of the previous clinical trial, the technique of acupressure at ST36 will be used to promote gastrointestinal movement compared with control group. The evidence-based basis is mainly derived from domestic and international guideline recommendations, Cochrane systematic review results, meta-analysis results, and large multi-centre randomized controlled trials. 3. Study on the mechanism of acupressure to promote gastrointestinal function By evaluating the 24-hour heart rate variability index of colorectal cancer surgery patients, the regulatory effect of acupressure on autonomic nerve will be evaluated, and the regulatory effect of acupressure on systemic inflammation will be revealed through the changes of postoperative inflammatory factors.
Interventions
OTHERAcupressure
In this study, the frequency of acupressure was twice a day (the interval between each acupressure was more than 6 hours, 6:00 to 9:00 in the morning and 1:00 to 4:00 in the afternoon); the acupressure was applied from the first day after surgery for a total of 5 days, that is, each patient received a total of 10 acupressure; the duration was 5 minutes, and the bilateral acupressure required 10 minutes.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with pathological diagnosis of colorectal cancer; * Adult patients (age ≥ 18 years); * Patients undergoing elective surgery, including open surgery, laparoscopic and combined surgery.
Exclusion criteria
* Inability to communicate due to language impairment or severe cognitive impairment; * Skin infection or defect of the lower extremities, which may hinder the localization of ST36 or worsen the infection; * Plan to perform more than one surgery during hospitalization; * There are coagulation disorders or peripheral vascular diseases or signs of impaired blood circulation in the lower extremities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | 24 hours after the end of acupressure on day 5 | The differential change of successive heartbeat cycles. Wear a multi-lead Holter (Lepu 12-lead ECG monitor) for 24 consecutive hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of C-reactive protein | Early morning on the day after the end of acupressure on day 5 | Inflammatory factor. Collect 3 ml of venous blood using a purple tube (Item: Blood Cell Analysis Five Classification (Vein) + C-Reactive Protein) |
| First postoperative exhaust time, defecation time, getting out of bed activity time, drinking time, eating time | Early morning on the day after surgery, up to 5 days | The time interval between the end of the procedure and the patient's first time of taking these activities. |
| Bowel motility | Early morning on the day after surgery, up to 5 days | The outcome assessors will assess the patients' bowel motility on abdominal auscultation by using a stethoscope for one full minute on the body surface above the ileocecal valve in the lower right corner of the abdomen. |
| level of IL-6 | Early morning on the day after the end of acupressure on day 5 | Inflammatory factor. Collect 3 ml of venous blood using a dark green heparin lithium anticoagulant long tube (Item: interleukin 6) |
| Abdominal distension | Early morning on the day after surgery, up to 5 days | The outcome assessors will directly asked patients perceived degree of abdominal distension by Numerical Rating Scale (NRS) from 0 to 10 (0 represents no bloating at all and 10 represents the most severe bloating that one can imagine). |
| Abdominal pain | Early morning on the day after surgery, up to 5 days | The outcome assessors will directly asked patients perceived degree of pain by Numerical Rating Scale (NRS) from 0 to 10 (0 represents no pain at all and 10 represents the most severe pain that one can imagine). |
| Postoperative nausea | Early morning on the day after surgery, up to 5 days | The outcome assessors will directly asked patients perceived degree of nausea by Numerical Rating Scale (NRS) from 0 to 10 (0 represents no nausea at all and 10 represents the most severe nausea that one can imagine). |
Contacts
Primary ContactYunhong Liu, PhD
Outcome results
None listed