Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery

NCT ID: NCT06118060

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Acupressure

Intervention Type OTHER

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.

control group

usual care group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yunhong Liu, PhD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yunhong Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yunhong Liu, PhD

Role: CONTACT

+86-0531-82169031

References

Explore related publications, articles, or registry entries linked to this study.

Abodeely A, Schechter S, Klipfel A, Vrees M, Lagares-Garcia J. Does alvimopan enhance return of bowel function in laparoscopic right colectomy? Am Surg. 2011 Nov;77(11):1460-2.

Reference Type BACKGROUND
PMID: 22196657 (View on PubMed)

Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.

Reference Type BACKGROUND
PMID: 26818619 (View on PubMed)

Chan HY, Chui YY, Chan CW, Cheng KK, Shiu AT, So WK, Ho SS, Chan MM. Exploring the influence of Traditional Chinese Medicine on self-care among Chinese cancer patients. Eur J Oncol Nurs. 2014 Oct;18(5):445-51. doi: 10.1016/j.ejon.2014.05.005. Epub 2014 Jun 20.

Reference Type BACKGROUND
PMID: 24954767 (View on PubMed)

Chao HL, Miao SJ, Liu PF, Lee HH, Chen YM, Yao CT, Chou HL. The beneficial effect of ST-36 (Zusanli) acupressure on postoperative gastrointestinal function in patients with colorectal cancer. Oncol Nurs Forum. 2013 Mar;40(2):E61-8. doi: 10.1188/13.ONF.E61-E68.

Reference Type BACKGROUND
PMID: 23448746 (View on PubMed)

Cho S, Shin A, Park SK, Shin HR, Chang SH, Yoo KY. Alcohol Drinking, Cigarette Smoking and Risk of Colorectal Cancer in the Korean Multi-center Cancer Cohort. J Cancer Prev. 2015 Jun;20(2):147-52. doi: 10.15430/JCP.2015.20.2.147.

Reference Type BACKGROUND
PMID: 26151048 (View on PubMed)

Drake TM, Ward AE. Pharmacological management to prevent ileus in major abdominal surgery: a systematic review and meta-analysis. J Gastrointest Surg. 2016 Jun;20(6):1253-64. doi: 10.1007/s11605-016-3140-0. Epub 2016 Apr 12.

Reference Type BACKGROUND
PMID: 27073081 (View on PubMed)

Fang JY, Dong HL, Sang XJ, Xie B, Wu KS, Du PL, Xu ZX, Jia XY, Lin K. Colorectal Cancer Mortality Characteristics and Predictions in China, 1991-2011. Asian Pac J Cancer Prev. 2015;16(17):7991-5. doi: 10.7314/apjcp.2015.16.17.7991.

Reference Type BACKGROUND
PMID: 26625831 (View on PubMed)

Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

Reference Type BACKGROUND
PMID: 28097305 (View on PubMed)

Martin L, Gillis C, Atkins M, Gillam M, Sheppard C, Buhler S, Hammond CB, Nelson G, Gramlich L. Implementation of an Enhanced Recovery After Surgery Program Can Change Nutrition Care Practice: A Multicenter Experience in Elective Colorectal Surgery. JPEN J Parenter Enteral Nutr. 2019 Feb;43(2):206-219. doi: 10.1002/jpen.1417. Epub 2018 Jul 23.

Reference Type BACKGROUND
PMID: 30035814 (View on PubMed)

Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2.

Reference Type BACKGROUND
PMID: 27253694 (View on PubMed)

Wu Z, Boersema GS, Dereci A, Menon AG, Jeekel J, Lange JF. Clinical endpoint, early detection, and differential diagnosis of postoperative ileus: a systematic review of the literature. Eur Surg Res. 2015;54(3-4):127-38. doi: 10.1159/000369529. Epub 2014 Dec 10.

Reference Type BACKGROUND
PMID: 25503902 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KYLL-202307-017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.