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

NCT07071987 | Recruiting

• 2 other identifiers: northernjiangsu00882373014
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to First Flatus

  Time (in hours) from the end of surgery to the first passage of gas per rectum

  Up to 96 hours after surgery

Study Arms (3)

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

Procedure: Thread Embedding Acupuncture+Electroacupuncture

Electroacupuncture Group

OTHER

Electroacupuncture

Procedure: Electroacupuncture

Control Group

NO INTERVENTION

Standard perioperative management without any acupuncture-related intervention

Interventions

Thread Embedding Acupuncture+Electroacupuncture PROCEDURE

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.

Thread embedding+Electroacupuncture Group

Electroacupuncture PROCEDURE

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

Electroacupuncture Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Low Anterior Resection Syndrome

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Daorong Wang, Doctor

CONTACT

8618051062590; wdaorong666@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 18, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)