Clinical trial NCT06118060: Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery
Official title: The Mechanism of Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: acupressure
postoperative ileus
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart rate variability
timeFrame: 24 hours after the end of acupressure on day 5
Secondary outcomes:
measure: level of IL-6
timeFrame: Early morning on the day after the end of acupressure on day 5
measure: Level of C-reactive protein
timeFrame: Early morning on the day after the end of acupressure on day 5
measure: First postoperative exhaust time, defecation time, getting out of bed activity time, drinking time, eating time
timeFrame: Early morning on the day after surgery, up to 5 days
measure: Bowel motility
timeFrame: Early morning on the day after surgery, up to 5 days
measure: Postoperative nausea
timeFrame: Early morning on the day after surgery, up to 5 days
measure: Abdominal distension
timeFrame: Early morning on the day after surgery, up to 5 days
measure: Abdominal pain
timeFrame: Early morning on the day after surgery, up to 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yunhong Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.