Clinical Study on the Efficacy of Abdominal Acupuncture in Promoting Gastrointestinal Function Recovery After Gynecological Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to first postoperative passage of flatus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients who underwent gynecologic laparoscopic total hysterectomy under general anesthesia;
- •Age between 18 and 65 years;
- •Surgical duration ranging from 0.5 to 4.5 hours;
- •Anesthesia duration ranging from 1 to 5 hours;
- •Willingness to receive acupuncture therapy without a history of adverse reactions such as needle syncope;
- •Provision of signed informed consent.
排除标准
- •Patients with comorbid conditions that may affect gastrointestinal function, including intestinal obstruction or space-occupying lesions of the digestive system;
- •Patients with severe systemic diseases, including hepatic or renal failure, cardiovascular or cerebrovascular disorders, infectious diseases such as HIV/AIDS, or severe psychiatric illness;
- •Individuals with a history of adverse reactions to acupuncture, including needle syncope;
- •Patients with local skin damage, rashes, or ulcers at the proposed acupoint sites;
- •Patients concurrently enrolled in other clinical studies.
结局指标
主要结局
Time to first postoperative passage of flatus
时间窗: From the end of surgery until the first documented passage of flatus; assessed through postoperative Day 5 or hospital discharge, whichever occurs first.
Elapsed time from the end of laparoscopic gynecologic surgery to the first documented passage of flatus; patient-reported and nurse-confirmed. Time is recorded in hours and minutes. Per protocol, rescue therapy may be used if no flatus by postoperative Day 3.
次要结局
- Inflammatory markers(Each parameter was assessed once preoperatively, on the day of surgery prior to treatment, and on postoperative Day 5.)
- Pain assessment(Day 0 (day of surgery) and Postoperative Days 1 through 5; or until hospital discharge if earlier.)
- Time to first postoperative bowel movement(From the end of surgery until the first documented bowel movement; assessed through postoperative Day 5 or hospital discharge, whichever occurs first.)
- restoration of bowel sounds(From the end of surgery until the first detection of normal bowel sounds; assessed every 8 hours through postoperative Day 5 or hospital discharge, whichever occurs first.)
- Incidence of postoperative gastrointestinal dysfunction(From the day of surgery through postoperative Day 5 or hospital discharge, whichever occurs first.)
- Gastrointestinal Symptom Score(Day 0 (day of surgery; pre-intervention assessment) and Postoperative Days 1 through 5; assessed once daily or until hospital discharge if earlier.)
- Gastrointestinal quality of life assessment(Day 0 (day of surgery; pre-intervention baseline), Postoperative Day 5 (or at hospital discharge if earlier), and approximately Postoperative Day 19 (14 days after the final treatment; allowable window ±2 days).)
研究者
Mengyao Han
Researcher
Guangdong Provincial Hospital of Traditional Chinese Medicine