Colorectal CancerTHREAD-POINCT07071987
Effect of Thread Embedding Acupuncture on Postoperative Ileus Recovery After Colorectal Cancer Surgery: A Multicenter Randomized Controlled Trial
A study testing Thread Embedding Acupuncture+Electroacupuncture and Electroacupuncture in people with Colorectal Cancer and Postoperative Ileus, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of thread embedding acupuncture (TEA) in promoting gastrointestinal recovery after laparoscopic colorectal cancer surgery. The primary outcome is the time to first flatus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Postoperative Ileus, LARS - Low Anterior Resection Syndrome
- What is being tested?
- Thread Embedding Acupuncture+Electroacupuncture and Electroacupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years Diagnosed with stage I-III colorectal cancer Scheduled for elective laparoscopic colorectal resection ASA Physical Status I-III Ability to provide informed consent
Who cannot join
- History of prior major abdominal surgery Emergency or palliative surgery Combined organ resection or open conversion Severe postoperative complications (e.g., anastomotic leak, GI bleeding) Severe cardiac, hepatic, renal, or psychiatric comorbidities Refusal to undergo acupuncture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Daorong Wang, 0514-87373114, wdaorong666@sina.com
About this study
Official title: A Multicenter, Randomized Controlled Trial to Evaluate the Efficacy of Thread Embedding Acupuncture in Reducing Postoperative Ileus After Colorectal Cancer Surgery
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of thread embedding acupuncture (TEA) in promoting gastrointestinal recovery after laparoscopic colorectal cancer surgery. The primary outcome is the time to first flatus. Secondary outcomes include time to first defecation, tolerance to oral intake, length of hospital stay, and patient-reported quality of life.
- Being tested
- Thread Embedding Acupuncture+Electroacupuncture, Electroacupuncture
- Medical subject headings
- Colorectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread Embedding Acupuncture+ElectroacupunctureProcedure or surgery
Thread embedding acupuncture will be administered at bilateral ST36, ST37, and PC6 acupoints at 2h after surgery and electroacupuncture at same acupoints at 2h 24h, 48h, and 72h after surgery. Absorbable polydioxanone sutures will be embedded into subcutaneous tissue using sterile embedding needles. All procedures will be conducted by licensed acupuncturists following standardized operating protocols.
ElectroacupunctureProcedure or surgery
Electroacupuncture will be performed at the same bilateral acupoints (ST36, ST37, and PC6)
| Study group | Role | What they receive |
|---|---|---|
| Thread embedding+Electroacupuncture Group | Experimental | Thread embedding at bilateral ST36, ST37, and PC6 at 2h after surgery and Electroacupuncture at same location at 2h, 24h, 48h, and 72h postoperatively Receives: Procedure: Thread Embedding Acupuncture+Electroacupuncture |
| Electroacupuncture Group | Other | Electroacupuncture Receives: Procedure: Electroacupuncture |
| Control Group | No intervention | Standard perioperative management without any acupuncture-related intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Flatus
Time (in hours) from the end of surgery to the first passage of gas per rectum
Measured: Up to 96 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071987
- Sponsor's protocol ID
- northernjiangsu008
- Other IDs
- 82373014
- Acronym
- THREAD-POI
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial to Evaluate the Efficacy of Thread Embedding Acupuncture in Reducing Postoperative Ileus After Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07071987
- Acronym / sponsor ID
- THREAD-POI / northernjiangsu008
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Jul 2025 (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.
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of thread embedding acupuncture (TEA) in promoting gastrointestinal recovery after laparoscopic colorectal cancer surgery. The primary outcome is the time to first flatus. Secondary outcomes include time to first defecation, tolerance to oral intake, length of hospital stay, and patient-reported quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thread embedding+Electroacupuncture Group | Experimental | Procedure: Thread Embedding Acupuncture+ElectroacupunctureThread embedding at bilateral ST36, ST37, and PC6 at 2h after surgery and Electroacupuncture at same location at 2h, 24h, 48h, and 72h postoperatively |
| Electroacupuncture Group | Other | Procedure: ElectroacupunctureElectroacupuncture |
| Control Group | No intervention | –Standard perioperative management without any acupuncture-related intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years Diagnosed with stage I-III colorectal cancer Scheduled for elective laparoscopic colorectal resection ASA Physical Status I-III Ability to provide informed consent
Key exclusion criteria (1 listed)
- History of prior major abdominal surgery Emergency or palliative surgery Combined organ resection or open conversion Severe postoperative complications (e.g., anastomotic leak, GI bleeding) Severe cardiac, hepatic, renal, or psychiatric comorbidities Refusal to undergo acupuncture
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 |
|---|---|---|
| Thread Embedding Acupuncture+ElectroacupunctureThread embedding acupuncture will be administered at bilateral ST36, ST37, and PC6 acupoints at 2h after surgery and electroacupuncture at same acupoints at 2h 24h, 48h, and 72h after surgery. Absorbable polydioxanone sutures will be embedded into subcutaneous tissue using sterile embedding needles. All procedures will be conducted by licensed acupuncturists following standardized operating protocols. | Procedure or surgery | Thread embedding+Electroacupuncture Group |
| ElectroacupunctureElectroacupuncture will be performed at the same bilateral acupoints (ST36, ST37, and PC6) | Procedure or surgery | Electroacupuncture Group |
Primary outcome
Time to First Flatus
Time frame: Up to 96 hours after surgery
Time (in hours) from the end of surgery to the first passage of gas per rectum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread Embedding Acupuncture+Electroacupuncture and Electroacupuncture in people with Colorectal Cancer and Postoperative Ileus, run by Northern Jiangsu People's 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daorong Wang, Doctor (8618051062590, wdaorong666@sina.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 (time frame: Up to 96 hours after 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 18 Jul 2025.