Gastroparesis PostoperativeDelayed Gastric Emptying Following Procedure
Investigational drug(s) / intervention(s)
Acupuncturesham acupuncture
Acupuncture: Intervention Description: Participants receive traditional Chinese medicine acupuncture administered using sterile filiform needles at acupoints selected based on clinical presentation. The treatment session duration and frequency are identical to those in the control group. All participants continue to receive standard postoperative care.
sham acupuncture: Participants receive sham acupuncture administered using identical filiform needles as the experimental group, with superficial insertion at non-acupoints and without needle manipulation. The treatment session duration and frequency are identical to those in the experimental group. All participants continue to receive standard postoperative care.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Time to Recovery from Postoperative Gastroparesis — From date of first diagnosis of postoperative gastroparesis through hospital discharge, assessed up to 12 months Time from first diagnosis of postoperative gastroparesis to recovery of gastroparesis, defined as resolution of symptoms (e.g., nausea, vomiting, abdominal distension), tolerance of oral intake, and removal of gastric decompression without recurrence
Trial sites (1)
Facility
City
Region
Status
Qilu hospital
Jinan
Shandong
Recruiting
More Qilu Hospital of Shandong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.