Colorectal CancerNCT06118060
Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery
A study testing Acupressure in people with Colorectal Cancer, run by Qilu Hospital of Shandong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathological diagnosis of colorectal cancer;
- Adult patients (age ≥ 18 years);
- Patients undergoing elective surgery, including open surgery, laparoscopic and combined surgery.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Mechanism of Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Acupressure
- Keywords
- acupressure, postoperative ileus
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Acupressure |
| control group | No intervention | usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
The differential change of successive heartbeat cycles. Wear a multi-lead Holter (Lepu 12-lead ECG monitor) for 24 consecutive hours.
Measured: 24 hours after the end of acupressure on day 5
Secondary outcomes (7)
level of IL-6
Inflammatory factor. Collect 3 ml of venous blood using a dark green heparin lithium anticoagulant long tube (Item: interleukin 6)
Measured: Early morning on the day after the end of acupressure on day 5
Level of C-reactive protein
Inflammatory factor. Collect 3 ml of venous blood using a purple tube (Item: Blood Cell Analysis Five Classification (Vein) + C-Reactive Protein)
Measured: 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
The time interval between the end of the procedure and the patient's first time of taking these activities.
Measured: Early morning on the day after surgery, up to 5 days
Bowel motility
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.
Measured: Early morning on the day after surgery, up to 5 days
Postoperative nausea
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).
Measured: Early morning on the day after surgery, up to 5 days
Abdominal distension
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).
Measured: Early morning on the day after surgery, up to 5 days
Abdominal pain
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).
Measured: Early morning on the day after surgery, up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunhong Liu, PhD, Qilu Hospital of Shandong University
- Investigators
- Yunhong Liu, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118060
- Sponsor's protocol ID
- KYLL-202307-017
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
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.
PubMed 22196657Arnold 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.
PubMed 26818619Chan 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.
PubMed 24954767Chao 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.
PubMed 23448746Cho 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.
PubMed 26151048Drake 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.
PubMed 27073081Fang 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.
PubMed 26625831Ljungqvist 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.
PubMed 28097305Martin 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.
PubMed 30035814Miller 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.
PubMed 27253694Wu 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.
PubMed 25503902
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06118060
- Acronym / sponsor ID
- KYLL-202307-017
- Conditions
- Colorectal Cancer
- Keywords
- acupressure, postoperative ileus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure group | Experimental | Other: AcupressureAfter 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). |
| control group | No intervention | –usual care group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pathological diagnosis of colorectal cancer;
- Adult patients (age ≥ 18 years);
- Patients undergoing elective surgery, including open surgery, laparoscopic and combined surgery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureIn 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. | Other | acupressure group |
Primary outcome
Heart rate variability
Time frame: 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.
7 secondary outcomes
level of IL-6
Time frame: Early morning on the day after the end of acupressure on day 5
Level of C-reactive protein
Time frame: 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
Time frame: Early morning on the day after surgery, up to 5 days
Bowel motility
Time frame: Early morning on the day after surgery, up to 5 days
Postoperative nausea
Time frame: Early morning on the day after surgery, up to 5 days
Abdominal distension
Time frame: Early morning on the day after surgery, up to 5 days
Abdominal pain
Time frame: Early morning on the day after surgery, up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 22196657Abodeely 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.
- Background: PubMed 26818619Arnold 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.
- Background: PubMed 24954767Chan 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.
- Background: PubMed 23448746Chao 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.
- Background: PubMed 26151048Cho 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.
- Background: PubMed 27073081Drake 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.
- Background: PubMed 26625831Fang 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.
- Background: PubMed 28097305Ljungqvist 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.
- Background: PubMed 30035814Martin 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.
- Background: PubMed 27253694Miller 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.
- Background: PubMed 25503902Wu 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunhong Liu, PhD principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Colorectal Cancer, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunhong Liu, PhD (+86-0531-82169031, yunhongyt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 24 hours after the end of acupressure on day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118060, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.