ColectomyPhase 2NCT07335237
Clinical Study on the Prevention and Treatment of Postoperative Gastrointestinal Dysfunction by Acupuncture Under ERAS Management Based on Artificial Intelligence Monitoring
A Phase 2 study testing Accupuncture in people with Colectomy and Colectomy Left/Right/Total Under Laparotomy, run by Jiangsu Province Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Brief Summary: Acupuncture for Faster Recovery After Colorectal Surgery 1. What is this study about? Colorectal cancer is a common health condition that usually requires surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colectomy, Colectomy Left/Right/Total Under Laparotomy, Cancer
- What is being tested?
- Accupuncture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 28 May 2025
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years, male or female.
- Diagnosed with colorectal malignancy by pathology or cytology.
- Scheduled for elective radical resection of colorectal cancer (laparoscopic or open surgery).
- ASA physical status classification: I-III.
- Willing and able to provide written informed consent.
Who cannot join
- Patients with severe primary diseases of the heart, brain, kidney, hematopoietic, or endocrine systems.
- History of major abdominal surgery or intestinal obstruction that significantly alters bowel anatomy.
- Emergency surgery cases (e.g., acute obstruction, perforation, or peritonitis).
- Contraindications to acupuncture (e.g., local skin infection, scars, or severe coagulation disorders).
- Currently participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Affliated Hospital of Nanjing Universitty of Chinese Medicine
Nanjing, Jiangsu, 210029
About this study
Official title: Objective: POGD is the Most Prevalent Complication Following Colon Cancer Surgery. The Integration of Acupuncture With ERAS Management Represents an Effective Approach for the Prevention and Treatment of POGD. Autonomic Nerve Function Serves as a Promising Target for Acupuncture Therapy; However, Its Precise Clinical Efficacy and Underlying Mechanisms Warrant Further Investigation. This Study Examines the Changes in Autonomic Nerve Function, Postoperative Gastrointestinal Recovery, and the Incidence of POGD in Patients Undergoing Colorectal Cancer Resection Under the ERAS Management Pathway, c
Brief Summary: Acupuncture for Faster Recovery After Colorectal Surgery
- What is this study about? Colorectal cancer is a common health condition that usually requires surgery. While surgery is effective, it often leads to a temporary "shutdown" of the digestive system, known as Postoperative Gastrointestinal Dysfunction (POGD). Patients may experience bloating, nausea, vomiting, and a delay in passing gas or having bowel movements. This study explores whether acupuncture can help the gut "wake up" faster and improve overall recovery.
- Why is this research important? Currently, hospitals use a modern management system called ERAS (Enhanced Recovery After Surgery) to help patients recover. However, many patients still suffer from gut-related discomfort. We want to see if combining traditional Chinese medicine (acupuncture) with modern ERAS protocols provides a better, faster, and more comfortable recovery than ERAS alone.
- What will happen during the study? Patients participating in this study at the affiliated hospital of Nanjing University of Chinese Medicine are randomly assigned to one of two groups: Standard Group: Receives standard ERAS care (early movement, early eating, and pain management). Acupuncture Group: Receives standard ERAS care plus professional acupuncture sessions. The Procedure: Fine, sterile needles are applied to specific points (such as Zusanli and Neiguan) for 30 minutes, twice a day for the first three days after surgery. Monitoring: To understand how the body responds, we use a non-invasive Artificial Intelligence (AI) monitor to track Heart Rate Variability (HRV). This helps us see how the nervous system is helping the gut recover in real-time.
- What are the potential benefits? Based on our research findings involving 70 clinical cases, patients who received acupuncture experienced: Faster Recovery: The first passage of gas occurred approximately 23 hours earlier than those in the standard group. Shorter Hospital Stay: Patients were able to go home on average one day sooner. Less Pain: Acupuncture significantly reduced postoperative pain levels. Fewer Complications: A lower rate of severe digestive issues after surgery.
- Is it safe? Acupuncture is a safe, drug-free, and minimally invasive therapy. It works by stimulating the vagus nerve and balancing the body's internal systems. Combined with the precision of AI monitoring, this approach ensures that the recovery process is both natural and scientifically tracked.
- Conclusion The goal of this study is to provide a "green" and effective solution to help colorectal cancer patients suffer less after surgery and return to their normal lives as quickly as possible.
- Conditions
- Colectomy, Colectomy Left/Right/Total Under Laparotomy, Cancer, Chinese Medicine, Accupuncture, Heart Rate
- Being tested
- Accupuncture
- Keywords
- Colectal Cancer, Chinese Medicine, Accupuncture
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccupunctureOther
Specific Synergistic Acupoint Selection: The protocol uses a specialized combination of four acupoints-Zusanli (ST36), Neiguan (PC6), Tianshu (ST25), and Taichong (LR3). This specific "cluster" is designed not just for gut motility, but to specifically target the "Brain-Gut Axis" to reduce the systemic inflammatory response and postoperative pain simultaneously.
High-Frequency Perioperative Timing: The intervention begins within 12 hours post-surgery, which is earlier than many traditional protocols. It is administered with a high-frequency density (every 12 hours for the first 72 hours), ensuring a consistent "dose" of neuro-stimulation during the most critical window of gastrointestinal paralysis.
| Study group | Role | What they receive |
|---|---|---|
| Standard ERAS Management | Active comparator | Patients in this arm receive standard perioperative care following the established Enhanced Recovery After Surgery (ERAS) protocols, including early mobilization and early oral feeding, without acupuncture intervention. Receives: Other: Accupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first postoperative flatus
This measure records the duration (in hours) from the completion of the surgical procedure (end of skin closure) to the patient's first reported passage of flatus. It serves as a key clinical indicator of the recovery of intestinal motility and the resolution of postoperative ileus.
Measured: From the end of surgery until the first passage of flatus, typically expected within 72 to 120 hours post-surgery.
Secondary outcomes (1)
Time to first postoperative defecation
Record the time elapsed from the end of the surgery (when the skin stitches were completed) until the patient passed their first stool after the operation, in hours. The occurrence of a bowel movement indicates the recovery of gastrointestinal motility.
Measured: From the end of the surgery until the 7th day after the operation (or until the patient is discharged from the hospital).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Sep 2022
- Primary completion28 Mar 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColectomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Wenhao, Jiangsu Province Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335237
- Sponsor's protocol ID
- 2022NL-KS100
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective: POGD is the Most Prevalent Complication Following Colon Cancer Surgery. The Integration of Acupuncture With ERAS Management Represents an Effective Approach for the Prevention and Treatment of POGD. Autonomic Nerve Function Serves as a Promising Target for Acupuncture Therapy; However, Its Precise Clinical Efficacy and Underlying Mechanisms Warrant Further Investigation. This Study Examines the Changes in Autonomic Nerve Function, Postoperative Gastrointestinal Recovery, and the Incidence of POGD in Patients Undergoing Colorectal Cancer Resection Under the ERAS Management Pathway, c
- ClinicalTrials.gov ID
- NCT07335237
- Acronym / sponsor ID
- 2022NL-KS100
- Conditions
- Colectomy, Colectomy Left/Right/Total Under Laparotomy, Cancer, Chinese Medicine, Accupuncture, Heart Rate
- Keywords
- Colectal Cancer, Chinese Medicine, Accupuncture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jiangsu Province Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 13 Jan 2026 (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.
Brief Summary: Acupuncture for Faster Recovery After Colorectal Surgery
- What is this study about? Colorectal cancer is a common health condition that usually requires surgery. While surgery is effective, it often leads to a temporary "shutdown" of the digestive system, known as Postoperative Gastrointestinal Dysfunction (POGD). Patients may experience bloating, nausea, vomiting, and a delay in passing gas or having bowel movements. This study explores whether acupuncture can help the gut "wake up" faster and improve overall recovery.
- Why is this research important? Currently, hospitals use a modern management system called ERAS (Enhanced Recovery After Surgery) to help patients recover. However, many patients still suffer from gut-related discomfort. We want to see if combining traditional Chinese medicine (acupuncture) with modern ERAS protocols provides a better, faster, and more comfortable recovery than ERAS alone.
- What will happen during the study? Patients participating in this study at the affiliated hospital of Nanjing University of Chinese Medicine are randomly assigned to one of two groups: Standard Group: Receives standard ERAS care (early movement, early eating, and pain management). Acupuncture Group: Receives standard ERAS care plus professional acupuncture sessions. The Procedure: Fine, sterile needles are applied to specific points (such as Zusanli and Neiguan) for 30 minutes, twice a day for the first three days after surgery. Monitoring: To understand how the body responds, we use a non-invasive Artificial Intelligence (AI) monitor to track Heart Rate Variability (HRV). This helps us see how the nervous system is helping the gut recover in real-time.
- What are the potential benefits? Based on our research findings involving 70 clinical cases, patients who received acupuncture experienced: Faster Recovery: The first passage of gas occurred approximately 23 hours earlier than those in the standard group. Shorter Hospital Stay: Patients were able to go home on average one day sooner. Less Pain: Acupuncture significantly reduced postoperative pain levels. Fewer Complications: A lower rate of severe digestive issues after surgery.
- Is it safe? Acupuncture is a safe, drug-free, and minimally invasive therapy. It works by stimulating the vagus nerve and balancing the body's internal systems. Combined with the precision of AI monitoring, this approach ensures that the recovery process is both natural and scientifically tracked.
- Conclusion The goal of this study is to provide a "green" and effective solution to help colorectal cancer patients suffer less after surgery and return to their normal lives as quickly as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard ERAS Management | Active comparator | Other: AccupuncturePatients in this arm receive standard perioperative care following the established Enhanced Recovery After Surgery (ERAS) protocols, including early mobilization and early oral feeding, without acupuncture intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 80 years, male or female.
- Diagnosed with colorectal malignancy by pathology or cytology.
- Scheduled for elective radical resection of colorectal cancer (laparoscopic or open surgery).
- ASA physical status classification: I-III.
- Willing and able to provide written informed consent.
Key exclusion criteria (5 listed)
- Patients with severe primary diseases of the heart, brain, kidney, hematopoietic, or endocrine systems.
- History of major abdominal surgery or intestinal obstruction that significantly alters bowel anatomy.
- Emergency surgery cases (e.g., acute obstruction, perforation, or peritonitis).
- Contraindications to acupuncture (e.g., local skin infection, scars, or severe coagulation disorders).
- Currently participating in other clinical trials.
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 |
|---|---|---|
| AccupunctureSpecific Synergistic Acupoint Selection: The protocol uses a specialized combination of four acupoints-Zusanli (ST36), Neiguan (PC6), Tianshu (ST25), and Taichong (LR3). This specific "cluster" is designed not just for gut motility, but to specifically target the "Brain-Gut Axis" to reduce the systemic inflammatory response and postoperative pain simultaneously. High-Frequency Perioperative Timing: The intervention begins within 12 hours post-surgery, which is earlier than many traditional protocols. It is administered with a high-frequency density (every 12 hours for the first 72 hours), ensuring a consistent "dose" of neuro-stimulation during the most critical window of gastrointestinal paralysis. | Other | Standard ERAS Management |
Primary outcome
Time to first postoperative flatus
Time frame: From the end of surgery until the first passage of flatus, typically expected within 72 to 120 hours post-surgery.
This measure records the duration (in hours) from the completion of the surgical procedure (end of skin closure) to the patient's first reported passage of flatus. It serves as a key clinical indicator of the recovery of intestinal motility and the resolution of postoperative ileus.
1 secondary outcome
Time to first postoperative defecation
Time frame: From the end of the surgery until the 7th day after the operation (or until the patient is discharged from the hospital).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Accupuncture in people with Colectomy and Colectomy Left/Right/Total Under Laparotomy, run by Jiangsu Province Hospital of Traditional Chinese Medicine 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 5 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: finished, as of the sponsor's last update on 13 Jan 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first postoperative flatus (time frame: From the end of surgery until the first passage of flatus, typically expected within 72 to 120 hours post-surgery.). 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 13 Jan 2026.