NCT07293026

Abdominal Acupuncture for Gastrointestinal Function Recovery After Gynecologic Laparoscopic Surgery

Clinical Study on the Efficacy of Abdominal Acupuncture in Promoting Gastrointestinal Function Recovery After Gynecological Laparoscopic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Mengyao Han · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Current research on the role of abdominal acupuncture in promoting postoperative gastrointestinal recovery remains limited, characterized by a lack of large-scale, standardized clinical trials, particularly with respect to long-term outcomes. This study, grounded in a rigorous randomized controlled trial design, investigates the clinical efficacy of abdominal acupuncture in enhancing gastrointestinal function following gynecologic laparoscopic surgery. The findings aim to provide a scientific foundation for improving postoperative quality of life, optimizing recovery pathways in gynecology, and identifying safer, simpler, and more effective therapeutic options. In addition, this work offers theoretical support and practical evidence to advance the clinical integration and broader application of traditional Chinese therapeutic approaches in modern surgical rehabilitation, underscoring its significant clinical value.

Detailed description

This single-center, randomized, parallel-group clinical trial evaluates the adjunctive use of Bo's abdominal acupuncture in women undergoing laparoscopic total hysterectomy at Guangdong Provincial Hospital of Chinese Medicine. The trial is designed to test whether adding abdominal acupuncture to standardized postoperative care can enhance gastrointestinal recovery and is safe in this setting. The protocol was approved by the institutional ethics committee. Eligible participants are randomized 1:1 using an independently generated, concealed allocation sequence (sequentially numbered, opaque, sealed envelopes). Because of the nature of the intervention, treating acupuncturists are not blinded, while outcome assessors and data analysts remain blinded to group assignment. All participants receive standardized postoperative care per institutional pathways, and therapies that directly affect gastrointestinal motility are restricted unless prespecified rescue criteria are met. Participants assigned to the intervention arm receive Bo's abdominal acupuncture beginning 4-6 hours after surgery and once daily on postoperative days 1-4 (five sessions in total). Treatment follows a standardized technique grounded in pattern differentiation, delivered with sterile single-use needles and approximately 30 minutes of needle retention; full procedural details are provided in the Interventions section of this record. Outcomes, instruments, and time frames are prespecified in the Outcome Measures module; the primary endpoint is time to first passage of flatus, and secondary measures encompass gastrointestinal recovery, adverse events and postoperative complications, inflammatory biomarkers, pain, and gastrointestinal quality of life. Safety is monitored throughout with reporting per institutional policy. Statistical analyses will follow an intention-to-treat approach where feasible, using appropriate parametric or nonparametric tests for continuous variables, chi-square or Fisher exact tests for categorical variables, and repeated-measures models for longitudinal data, with two-sided α=0.05 and effect estimates reported with 95% confidence intervals.

Conditions

• Postoperative Complications
• Postoperative Gastrointestinal Dysfunction (POGD)
• Postoperative Ileus

Interventions

Type	Name	Description
PROCEDURE	Abdominal acupuncture	Patients were positioned supine with the abdomen exposed. Acupoint selection and localization followed Abdominal Acupuncture Therapy standards, with proportional measurements taken from the umbilicus (CV8): 8 cun upward to CV16, 5 cun downward to the pubic symphysis, and 6 cun laterally. After hand hygiene and aseptic skin preparation, disposable sterile needles were inserted perpendicularly. Primary acupoints were needled at the Di level (1.0-1.5 cun) targeting visceral disorders, and secondary acupoints at the Ren level (0.5-1.0 cun) for peripheral regulation. Gentle rotation was employed without lifting/thrusting, and deqi induction was not required. Needles were retained for 30 minutes with concurrent infrared warming therapy. Post-treatment, needles were withdrawn with sterile compression applied to prevent bleeding. The first session was given 4-6 hours postoperatively, followed by one session daily on postoperative days 1-4, for a total of five sessions.
OTHER	Standard postoperative management protocol	Multimodal perioperative care including early oral intake, early mobilization, fluid and electrolyte balance, prophylactic antibiotics, device removal, multimodal analgesia, and supportive monitoring; gastrointestinal prokinetics, enemas, and herbal medicines prohibited.

Timeline

• Start date: 2023-12-21
• Primary completion: 2024-12-20
• Completion: 2025-01-20
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: China