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Effect of Thread Embedding Acupuncture on Postoperative Ileus Recovery After Colorectal Cancer Surgery: A Multicenter Randomized Controlled Trial

A Multicenter, Randomized Controlled Trial to Evaluate the Efficacy of Thread Embedding Acupuncture in Reducing Postoperative Ileus After Colorectal Cancer Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07071987
Acronym
THREAD-POI
Enrollment
300
Registered
2025-07-18
Start date
2025-08-01
Completion date
2027-07-31
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, LARS - Low Anterior Resection Syndrome, Postoperative Ileus

Brief 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. Secondary outcomes include time to first defecation, tolerance to oral intake, length of hospital stay, and patient-reported quality of life.

Interventions

PROCEDUREThread Embedding Acupuncture+Electroacupuncture

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.

PROCEDUREElectroacupuncture

Electroacupuncture will be performed at the same bilateral acupoints (ST36, ST37, and PC6)

Sponsors

Northern Jiangsu People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants were blinded to their group assignment. In the sham group, blunt needles were placed at the same acupoints using adhesive pads without skin penetration or electrical stimulation, simulating the appearance of real thread embedding. Outcome assessors and investigators responsible for data collection and analysis were also blinded to the group allocation. Care providers performing the procedure were not blinded due to the nature of the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Time to First FlatusUp to 96 hours after surgeryTime (in hours) from the end of surgery to the first passage of gas per rectum

Countries

China

Contacts

Primary ContactDaorong Wang, Doctor
wdaorong666@sina.com8618051062590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026