Acupuncture for Postoperative Gastric Emptying Delay
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Hospital of Shandong University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-80 years, regardless of sex.
Patients who have undergone partial gastrectomy.
Patients presenting with postoperative gastroparesis symptoms, confirmed by imaging or gastric emptying scintigraphy, and clinically diagnosed with gastroparesis.
No severe cardiac, hepatic, renal, or coagulation dysfunction.
Disqualifiers
Patients with severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or coagulation disorders.
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.
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.
Patients with diagnosed psychiatric disorders, cognitive impairment, or those unable to cooperate with treatment procedures, symptom assessment, or follow-up.
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Procedure/SurgeryIntervention 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
Procedure/SurgeryParticipants 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.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Acupuncture GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Recovery from Postoperative Gastroparesis
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
Time frame
From date of first diagnosis of postoperative gastroparesis through hospital discharge, assessed up to 12 monthsSecondary outcomes
1
Change in Gastroparesis Cardinal Symptom Index score
Gastroparesis Cardinal Symptom Index (GCSI) total score (range: 0-5), where higher scores indicate more severe symptoms.
Time frame
Baseline, Day 7, Day 14, 1, 3, 6, and 12 months2
Daily Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Score
Daily Gastroparesis Cardinal Symptom Index Daily Diary total score (GCSI-DD) (range: 0-4), where higher scores indicate more severe symptoms
Time frame
From enrollment to the resolution of gastroparesis up to 12 months3
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30（EORTC QLQ-C30 ）Score
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores (range: 0-100). For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom severity; for global health status, higher scores indicate better overall quality of life
Time frame
Baseline, Day 7, Day 14, 1, 3, 6, and 12 months4
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Stomach Module （EORTC QLQ-STO22 ）Score
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Stomach Module (EORTC QLQ-STO22) scores (range: 0-100), with higher scores representing greater symptom burden
Time frame
Baseline, Day 7, Day 14, 1, 3, 6, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Qilu Hospital of Shandong University
Lead sponsor
Weifang Yidu Central Hospital
Collaborator
The People's Hospital of Yinan County
Collaborator
Source ClinicalTrials.gov