Colorectal CancerNCT04822506
PEA Promote Gastrointestinal Function Recovered After Colorectal Cancer Operation
A study testing Routine perioperative management and PEA and Routine perioperative management and postEA in people with Colorectal Cancer, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial summary
To investigate whether perioperative electroacupuncture is more effective than postoperative electroacupuncture in improving gastrointestinal function after colorectal cancer operation Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Routine perioperative management and PEA and Routine perioperative management and postEA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2021to 31 Oct 2023
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnostic criteria of colorectal cancer and need elective radical resection of colorectal cancer;
- 18≤ age≤79, gender is not limited;
- Understand and agree to participate in the study and sign the informed consent;
- No previous history of abdominal surgery and no abdominal adhesion;
Who cannot join
- Patients with mental illness;
- Patients requiring combined resection of other organs;
- Participated in or is participating in other clinical researchers in the previous 3 months
- People who have received acupuncture (including electroacupuncture) in the past;
- Other treatment options are being used (chemotherapy, radiotherapy, etc.) Those who meet any of the above criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai
Jia Zhou, M.D., pdzhoujia@163.com
Ke Wang, Ph D, wangke8430@163.com
About this study
Official title: Perioperative Electroacupuncture Promotes Early Gastrointestinal Function Rehabilitation After Radical Resection of Colorectal Cancer: a Pilot Trial
To investigate whether perioperative electroacupuncture is more effective than postoperative electroacupuncture in improving gastrointestinal function after colorectal cancer operation
Read the detailed description
Although there are large intestine cancer postoperative clinical research of acupuncture, but fewer sample size, whether perioperative acupuncture intervention is superior to the postoperative acupuncture intervention, remains to be seen, so investigators proposed to carry out the preliminary experiment, the data can be collected according to the different characteristics of perioperative, perioperative choose different acupoints compatibility, give full play to the needle medicine compound anesthesia in colorectal cancer surgery play a unique function of viscera protection, to explore the curative in colorectal cancer surgery perioperative intervened to promote the role of gastrointestinal function after surgery for early rehabilitation provides evidence-based medical evidence, develop and optimize the acupuncture and drugs combined anesthesia in colorectal cancer surgery perioperative application of specification, It promoted the establishment of the first treatment mode of "accelerated recovery in perioperative period of colorectal cancer operation based on combined acupuncture and drug anesthesia"
- Conditions
- Colorectal Cancer
- Being tested
- Routine perioperative management and PEA, Routine perioperative management and postEA
- Keywords
- electroacupuncture, ERAS, Gastrointesinal function
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine perioperative management and PEAProcedure or surgery
Routine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Preoperation:RN 6 + RN 4 +ST30 + ST 36+ Hegu (bilateral),De qi, electroacupuncture, continuous wave, 5Hz, 30min before surgery at 19:00 PM Inoperatively: LI 4+ PC 6 + ST36 + GB 34 (bilateral) ,Deqi, electroacupuncture with density wave, 2/100Hz, 30 minutes before operation to the end of the operation Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF)
Routine perioperative management and postEAProcedure or surgery
Routine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF)
| Study group | Role | What they receive |
|---|---|---|
| Routine perioperative management and PEA | Experimental | Routine perioperative management and perioperative electroacupuncture (preoperative, intraoperative, postoperative)； Receives: Procedure: Routine perioperative management and PEA |
| Routine perioperative management and postEA | Active comparator | Routine perioperative management and postoperative electroacupuncture Receives: Procedure: Routine perioperative management and postEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first flatus (TFF)
time to first flatus
Measured: Day 3
Secondary outcomes (15)
Recovery time of postoperative bowel sounds
The enteric voice continuous auscultation recorder was used to monitor immediately after operation, and the time to the end of operation was calculated
Measured: Day 3
Time of first postoperative defecation
Patients self-report their defecation and doctors record the time
Measured: Day 3
Dietary recovery
First time of water intake, tolerance to liquid diet time, tolerance to solid diet time
Measured: Day 3
Postoperative gastrointestinal dysfunction
Duration and frequency of postoperative appearance: nausea, emesis,ventosity
Measured: Day 3
Quality of life scale 1
EORTC QLQ-C30（Version 3.0 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (standard score, SS, range from 0 to 100, higher scores mean a better outcome);
Measured: "Day 0"，"Day 3"，"Day 7"
Quality of life scale 2
SF-36(Chinese version),The Short Form (36) Health Survey,( The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability)
Measured: "Day 0"，"Day 3"，"Day 7"
Postperation pain
VAS,Visual analogy score (0 to 10,higher scores mean a worse outcome)
Measured: Day 3
Motor function
Walking independently after surgery
Measured: Day 3
LOS(length of stay)
From admission to discharge
Measured: Day 7
Biochemical indexes
C-reactive protein(CRP)，motilin(MTL).Gastrin(GAS),vasoactive peptide(VIP)
Measured: "Day 0"，"Day 3"
Biochemical indexes 1
C-reactive protein(CRP, ug/L)
Measured: "Day 0"，"Day 3"
Biochemical indexes 2
Motilin(MTL, ng/L)
Measured: "Day 0"，"Day 3"
Biochemical indexes 3
Gastrin(GAS, ng/L)
Measured: "Day 0"，"Day 3"
Biochemical indexes 4
vasoactive peptide(VIP, pg/L)
Measured: "Day 0"，"Day 3"
Adverse Event Assessment
Any adverse events in the study
Measured: "Day 0"，"Day 3"，"Day 7"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start31 Jul 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, MD, Study director, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822506
- Sponsor's protocol ID
- 2019XZZX-ZJ0011
- Status last verified
- Jan 2023
- First submitted
- 23 Feb 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through the article publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Electroacupuncture Promotes Early Gastrointestinal Function Rehabilitation After Radical Resection of Colorectal Cancer: a Pilot Trial
- ClinicalTrials.gov ID
- NCT04822506
- Acronym / sponsor ID
- 2019XZZX-ZJ0011
- Conditions
- Colorectal Cancer
- Keywords
- electroacupuncture, ERAS, Gastrointesinal function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 30 Mar 2021 (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.
To investigate whether perioperative electroacupuncture is more effective than postoperative electroacupuncture in improving gastrointestinal function after colorectal cancer operation
Detailed description
Although there are large intestine cancer postoperative clinical research of acupuncture, but fewer sample size, whether perioperative acupuncture intervention is superior to the postoperative acupuncture intervention, remains to be seen, so investigators proposed to carry out the preliminary experiment, the data can be collected according to the different characteristics of perioperative, perioperative choose different acupoints compatibility, give full play to the needle medicine compound anesthesia in colorectal cancer surgery play a unique function of viscera protection, to explore the curative in colorectal cancer surgery perioperative intervened to promote the role of gastrointestinal function after surgery for early rehabilitation provides evidence-based medical evidence, develop and optimize the acupuncture and drugs combined anesthesia in colorectal cancer surgery perioperative application of specification, It promoted the establishment of the first treatment mode of "accelerated recovery in perioperative period of colorectal cancer operation based on combined acupuncture and drug anesthesia"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine perioperative management and PEA | Experimental | Procedure: Routine perioperative management and PEARoutine perioperative management and perioperative electroacupuncture (preoperative, intraoperative, postoperative)； |
| Routine perioperative management and postEA | Active comparator | Procedure: Routine perioperative management and postEARoutine perioperative management and postoperative electroacupuncture |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet the diagnostic criteria of colorectal cancer and need elective radical resection of colorectal cancer;
- 18≤ age≤79, gender is not limited;
- Understand and agree to participate in the study and sign the informed consent;
- No previous history of abdominal surgery and no abdominal adhesion;
Key exclusion criteria (5 listed)
- Patients with mental illness;
- Patients requiring combined resection of other organs;
- Participated in or is participating in other clinical researchers in the previous 3 months
- People who have received acupuncture (including electroacupuncture) in the past;
- Other treatment options are being used (chemotherapy, radiotherapy, etc.) Those who meet any of the above criteria will be excluded from the study.
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 |
|---|---|---|
| Routine perioperative management and PEARoutine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Preoperation:RN 6 + RN 4 +ST30 + ST 36+ Hegu (bilateral),De qi, electroacupuncture, continuous wave, 5Hz, 30min before surgery at 19:00 PM Inoperatively: LI 4+ PC 6 + ST36 + GB 34 (bilateral) ,Deqi, electroacupuncture with density wave, 2/100Hz, 30 minutes before operation to the end of the operation Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF) | Procedure or surgery | Routine perioperative management and PEA |
| Routine perioperative management and postEARoutine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF) | Procedure or surgery | Routine perioperative management and postEA |
Primary outcome
time to first flatus (TFF)
Time frame: Day 3
time to first flatus
15 secondary outcomes
Recovery time of postoperative bowel sounds
Time frame: Day 3
Time of first postoperative defecation
Time frame: Day 3
Dietary recovery
Time frame: Day 3
Postoperative gastrointestinal dysfunction
Time frame: Day 3
Quality of life scale 1
Time frame: "Day 0"，"Day 3"，"Day 7"
Quality of life scale 2
Time frame: "Day 0"，"Day 3"，"Day 7"
Postperation pain
Time frame: Day 3
Motor function
Time frame: Day 3
LOS(length of stay)
Time frame: Day 7
Biochemical indexes
Time frame: "Day 0"，"Day 3"
Biochemical indexes 1
Time frame: "Day 0"，"Day 3"
Biochemical indexes 2
Time frame: "Day 0"，"Day 3"
Biochemical indexes 3
Time frame: "Day 0"，"Day 3"
Biochemical indexes 4
Time frame: "Day 0"，"Day 3"
Adverse Event Assessment
Time frame: "Day 0"，"Day 3"，"Day 7"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: Yes. Through the article publication
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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.
Jia Zhou, MD study director
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine perioperative management and PEA and Routine perioperative management and postEA in people with Colorectal Cancer, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
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 4 inclusion and 5 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ke Wang, PhD (021-65161782 ext. +86, wangke8430@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first flatus (TFF) (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2023.