Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06118060

Collaborator

(none)

104

Enrollment

Arms

20.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Other: Acupressure	N/A

Detailed Description

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:

To shorten the length of hospital stay, and save medical resources in patients with colorectal cancer surgery;
To reveal the mechanism of acupressure, focusing on autonomic regulation and inflammatory response;
To explore the association of autonomic regulation with self-reported anxiety, depression, and stress.
Study plan 3.1 Design of experiments
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.
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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Mechanism of Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acupressure group 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).	Other: Acupressure 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.
No Intervention: control group usual care group

Arm

Intervention/Treatment

Experimental: acupressure group

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).

Other: Acupressure

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.

No Intervention: control group

usual care group

Outcome Measures

Primary Outcome Measures

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

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)
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.
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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Qilu Hospital of Shandong University

Investigators

Principal Investigator: Yunhong Liu, PhD, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Yunhong Liu, PhD, Assistant professor, Qilu Hospital of Shandong University

ClinicalTrials.gov Identifier:

NCT06118060

Other Study ID Numbers:

KYLL-202307-017

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yunhong Liu, PhD, Assistant professor, Qilu Hospital of Shandong University

acupressure

postoperative ileus

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Nov 7, 2023