Acupuncture for Postoperative Gastric Emptying Delay

This multicenter clinical trial, conducted at Qilu Hospital of Shandong University and collaborating institutions, prospectively assesses the efficacy and safety of acupuncture for postoperative delayed gastric emptying. Eligible participants will be prospectively enrolled and randomized into different groups per the study protocol. The primary endpoint is the reduction in the duration of delayed gastric emptying, while secondary endpoints include the complete resolution of cardinal gastroparetic symptoms, such as abdominal distension, nausea, and vomiting. All study procedures adhere to the ethical standards outlined in the approved protocol.

This prospective, randomized, controlled, multicenter trial, conducted collaboratively by Qilu Hospital of Shandong University and its partner institutions, evaluates the efficacy and safety of acupuncture for the treatment of postoperative delayed gastric emptying (DGE). objectives： Primary objectives: 1. To assess the clinical efficacy of acupuncture in patients with gastroparesis after partial gastrectomy, specifically in terms of promoting the recovery of gastric motility, accelerating gastric emptying, and alleviating symptoms as measured by the Gastroparesis Cardinal Symptom Index (GCSI). 2. To provide robust evidence-based medical evidence for the use of acupuncture in managing postoperative gastroparesis. 3. The objective of this study is to evaluate the efficacy and safety of acupuncture for gastroparesis following partial gastrectomy in a randomized controlled trial. Secondary objective: To evaluate the safety of acupuncture by monitoring the incidence of adverse events associated with the treatment. Study Design This study is a multicenter, randomized, single-blind, parallel-controlled clinical trial. The trial will be conducted at Qilu Hospital of Shandong University, Weifang Yidu Central Hospital, and Yinan County People's Hospital. A total of 176 patients who develop gastroparesis following partial gastrectomy will be recruited. Participants will be randomly assigned in a 1:1 ratio to either the Sham Acupuncture group or the Normal Acupuncture group. The randomization sequence will be generated by the Quality Control Committee using a computer-based random number generator. During the treatment period, clinical data, intraoperative information, perioperative status, and postoperative outcomes related to gastroparesis will be collected from both groups. Gastric fluid and blood samples will also be obtained for relevant laboratory analyses. In addition, patients will be followed up to evaluate the clinical efficacy of acupuncture for gastroparesis after gastric surgery. Clinical data, including intraoperative findings and perioperative parameters, were systematically collected for all participants. Postoperative outcomes following acupuncture intervention were documented. Blood samples were obtained for laboratory analyses. All patients were followed up to demonstrate the clinical efficacy of acupuncture in patients with postoperative gastric paralysis Intervention Measures Licensed acupuncturists underwent standardized training in acupoint localization and needling techniques to ensure procedural uniformity. Participants received standard clinical management-including dietary modifications, gastrointestinal decompression, enteral nutrition, and prokinetic agents-and were subsequently randomized into two study arms: Acupuncture Group (AG): Received active acupuncture in conjunction with standard care. Sham Acupuncture Group (SAG): Received standard care combined with non-penetrating sham acupuncture. Blunt-tipped sterile trial.show_full_description

Inclusion Criteria: 1. Aged 18-80 years, regardless of sex. 2. Patients who have undergone partial gastrectomy. 3. Patients presenting with postoperative gastroparesis symptoms, confirmed by imaging or gastric emptying scintigraphy, and clinically diagnosed with gastroparesis. 4. No severe cardiac, hepatic, renal, or coagulation dysfunction. 5. No participation in other interventional clinical trials within the past month. 6. Able to provide written informed consent and comply with the treatment and follow-up procedures. Exclusion Criteria: 1. Patients with severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or coagulation disorders. 2. Patients who develop serious postoperative complications after partial gastrectomy, such as anastomotic leakage, gastrointestinal bleeding, or severe infections, or conditions that may affect the assessment of gastric motility, such as ascites or intestinal obstruction. 3. Patients with a known allergy to acupuncture or with skin damage, infection, or severe scarring at the needle insertion sites that would prevent proper acupoint selection or needling. 4. Patients with diagnosed psychiatric disorders, cognitive impairment, or those unable to cooperate with treatment procedures, symptom assessment, or follow-up. 5. Patients who have used medications that may significantly affect gastric motility within the past week and cannot discontinue their use. 6. Pregnant or breastfeeding women, or individuals with other special physiological conditions that may make them unsuitable for participation in acupuncture research.