Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Acupressure

• Registration Number: NCT06118060
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Study Timeline

• Study First Submitted: 2023-10-16
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupressure group	Acupressure	After surgery, the patient is placed in a supine position, exposing both calves, and the operator sits on the edge of the bed and applies acupressure with the thumb or pressing tool (homemade).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.
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).
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)
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.
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).