Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery

NCT06118060 | Unknown

• 1 other identifier: KYLL-202307-017
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

acupressure; postoperative ileus

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  The differential change of successive heartbeat cycles. Wear a multi-lead Holter (Lepu 12-lead ECG monitor) for 24 consecutive hours.

  24 hours after the end of acupressure on day 5

Secondary Outcomes (7)

• level of IL-6

  Early morning on the day after the end of acupressure on day 5

• Level of C-reactive protein

  Early morning on the day after the end of acupressure on day 5

• 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

• Bowel motility

  Early morning on the day after surgery, up to 5 days

• Postoperative nausea

  Early morning on the day after surgery, up to 5 days

Study Arms (2)

acupressure group

EXPERIMENTAL

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

control group

NO INTERVENTION

usual care group

Interventions

Acupressure 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.

acupressure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathological diagnosis of colorectal cancer;
• Adult patients (age ≥ 18 years);
• Patients undergoing elective surgery, including open surgery, laparoscopic and combined surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Related Publications (11)

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  PMID: 22196657 BACKGROUND

• 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.

  PMID: 26818619 BACKGROUND

• 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.

  PMID: 24954767 BACKGROUND

• 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.

  PMID: 23448746 BACKGROUND

• 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.

  PMID: 26151048 BACKGROUND

• 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.

  PMID: 27073081 BACKGROUND

• 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.

  PMID: 26625831 BACKGROUND

• 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.

  PMID: 28097305 BACKGROUND

• 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.

  PMID: 30035814 BACKGROUND

• 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.

  PMID: 27253694 BACKGROUND

• 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.

  PMID: 25503902 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yunhong Liu, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunhong Liu, PhD

CONTACT

+86-0531-82169031; yunhongyt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to yunhongyt@163.com.