Gastrointestinal DysfunctionNCT07607249
Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle
A study testing Fu's Acupuncture group and Mosapride in people with Gastrointestinal Dysfunction, run by Zhenyu Zhang at 1 site in China.
Trial summary
A randomized controlled trial was conducted to compare the clinical efficacy of Fu's subcutaneous acupuncture and western medication in the treatment of gastrointestinal dysfunction after knee surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- Fu's Acupuncture group and Mosapride
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 27 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Met the diagnostic criteria for postoperative gastrointestinal dysfunction as defined in the Clinical Practice Guidelines for the Prevention and Treatment of Postoperative Gastrointestinal Dysfunction Using Integrated Traditional Chinese and Western Medicine;
- Underwent elective knee surgery under general anesthesia;
- Had normal bowel habits prior to hospital admission;
- Were aged 18-80 years;
- Had no severe systemic comorbidities or organic gastrointestinal disorders;
- Provided written informed consent after receiving comprehensive information regarding the study's objectives, procedures, potential benefits, and associated risks.
- All patients in both groups received standard postoperative symptomatic management, including routine wound dressing changes and patient-controlled analgesia.
Who cannot join
- Patients with chronic diarrhea or constipation attributable to organic etiologies; those with confirmed organic lesions of the large intestine (e.g., inflammatory bowel disease, diverticulosis, or neoplasms); individuals diagnosed with malignant tumors; patients who developed postoperative complications including intra-abdominal infection, abdominal hemorrhage, or cerebrovascular events requiring transfer to the intensive care unit;
- Patients with severe cardiac, hepatic, or renal dysfunction (e.g., NYHA Class IV heart failure, Child-Pugh Class C cirrhosis, or estimated glomerular filtration rate <30 mL/min/1.73 m²);
- Patients with primary immunodeficiency disorders, active systemic infections, or uncontrolled autoimmune diseases;
- Patients with recent abdominal trauma, acute surgical abdomen, or documented hypersensitivity to any intervention-related medications or materials;
- Presence of active dermatological conditions-including macules, papules, erythema, urticaria, abrasions, lacerations, or ulcerations-at the intended site of Fu's subcutaneous needle insertion;
- Patients exhibiting severe needle phobia, persistent vertigo, or cognitive/psychological impairment that precludes reliable adherence to treatment protocols or informed consent procedures;
- Patients who initiated concomitant therapies (pharmacologic or non-pharmacologic) not stipulated in the study protocol after enrollment, thereby confounding efficacy assessment; and those with incomplete baseline or follow-up data essential for primary or secondary outcome evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
A randomized controlled trial was conducted to compare the clinical efficacy of Fu's subcutaneous acupuncture and western medication in the treatment of gastrointestinal dysfunction after knee surgery under general anesthesia. The difference in clinical efficacy between the Fu's subcutaneous acupuncture group and the western medication group was analyzed, and the mechanism of Fu's subcutaneous acupuncture in the treatment of gastrointestinal dysfunction after general anesthesia was further explored. It was confirmed that Fu's subcutaneous acupuncture can effectively promote postoperative gastrointestinal motility and reduce postoperative gastrointestinal discomfort. It can shorten the recovery time of gastrointestinal function, improve the quality of life of patients during the perioperative period, and explore the improvement of postoperative complications and promote the postoperative rehabilitation of patients, which is worthy of clinical application.
Read the detailed description
Postoperative gastrointestinal dysfunction refers to the symptoms such as abdominal distension, nausea and vomiting, constipation, and weakened or disappeared bowel sounds caused by preoperative anesthesia, postoperative fasting, use of analgesics, prolonged bed rest, and early drinking after surgery. It is a common complication of surgery. The use of opioid analgesics during and after general anesthesia can bind to the opioid receptors distributed in the presynaptic neurons of the intestinal muscle layer, resulting in the decrease of intestinal peristalsis waves and the cessation of motility, leading to the occurrence of postoperative gastrointestinal dysfunction, with an incidence of up to 81%. The delayed recovery of gastrointestinal function after surgery can lead to intestinal obstruction or paralysis, anastomotic leakage and other complications. It not only has adverse effects on the recovery process and quality of life, but also may increase the consumption of medical resources. Studies have shown that the incidence of Postoperative gastrointestinal dysfunction in abdominal surgery can be as high as 10% to 30%. In recent years, the incidence of Postoperative gastrointestinal dysfunction has not decreased significantly, but has increased by 10% in Japan. Patients with Postoperative gastrointestinal dysfunction have a longer hospital stay than those without POGD, and have more postoperative complications such as infection and postoperative intestinal obstruction, which brings a greater economic burden to patients and society. At present, a simple, convenient and effective method to restore gastrointestinal function is the key to reduce postoperative complications and rapid recovery to reduce the length of hospital stay, and it is also the key problem to be solved during the perioperative period.
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- Fu's Acupuncture group, Mosapride
- Keywords
- Gastrointestinal dysfunction, postoperative gastrointestinal disorder, Fu's Subcutaneous Needling, FSN, Fu's Acupuncture, FSN acupuncture Needle, Knee Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu's Acupuncture groupDevice
The Fu's Acupuncture group received treatment 6 hours after the operation. One treatment session was conducted. The therapeutic effects were observed at 1 hour, 12 hours, and 36 hours after the treatment.
MosaprideDrug
On the basis of routine postoperative care, the patients in the control group were treated with mosapride citrate tablets (Runan Beite Pharmaceutical Co., LTD., Chinese Medicine approved number H19990317, standard: 5mg), 5mg/ time, 3 times /d.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Active comparator | Not described Receives: Drug: Mosapride |
| Fu's Acupuncture group | Experimental | Not described Receives: Device: Fu's Acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first postoperative exhaust and defecation time
- Exhaust time was recorded as the interval from the end of the operation to the first exhaust.
- Defecation time was recorded as the interval from the end of surgery to the first defecation.
The first postoperative exhaust and defecation time were recorded at 6 hours, 12 hours, 36 hours and 72 hours after operation
Measured: 6 hours/12 hours/36 hours/72 hours
Recovery time of bowel sounds
Recovery time of bowel sounds: auscultation was performed 6 hours after the operation in both groups, and the bowel sounds were recorded 6 hours /12 hours /36 hours /72 hours after the operation. During abdominal auscultation, five key auscultation areas were selected: left lower abdomen, left upper abdomen, right upper abdomen, right lower abdomen and around the umbilicus (G letter shape). At least 3 minutes of auscultation per auscultation area, bowel sounds were assessed as being in the normal range only if they were heard in two or more areas at a frequency of (3-5) beats/min. The patients in the treatment group were treated with Fu's subcutaneous needling after operation, and the bowel sounds were recorded once after each treatment. Each auscultation was recorded by a special person.
Postoperative bowel sound recovery time: the time between the end of surgery and the time when bowel sounds returned to normal.
Measured: 6 hours /12 hours /36 hours /72 hours
Secondary outcomes (2)
Gastrointestinal Symptom Rating Scale, GSRS
According to the Chinese version of gastrointestinal symptom rating scale, GSRS included 15 items of abdominal pain, abdominal distension, nausea, vomiting, belching, acid reflux, satiety, loss of appetite, abdominal burning, abdominal discomfort, abnormal bowel sounds, difficult exhaust, incomplete defecation, dry stool and straining defecation. The severity and frequency of GSRS were evaluated. The sum of the scores of the two dimensions of all symptoms was the GSRS score, which ranged from 0 to 60, with higher scores indicating more severe symptoms. The GSRS scores were calculated immediately, 6h, 12h and 36h after treatment.
Measured: hour 6/hour 12/hour 36
Five-point Likert scale for abdominal distension
The degree of abdominal distension of the two groups was recorded before treatment, 6 h, 12 h and 36 h after treatment. The abdominal distension score was formulated according to the "Practical Integrated Traditional Chinese and Western Medicine Diagnosis and Therapy" and related literature using the 5-point Likert scale.For example, score 0: no abdominal distension or discomfort throughout the day; Score 1: occasional abdominal distention and discomfort throughout the day, but did not affect rest; score 2: persistent abdominal distention and discomfort for a long time throughout the day, affecting rest but could tolerate; Score 3: abdominal distension and discomfort for a long time throughout the day, affecting rest but can be tolerated; Score 4: persistent abdominal distention and discomfort throughout the day, affecting rest and requiring medication; 5 points: persistent severe abdominal distention and discomfort throughout the day, abdominal distention, percussion drum sounds
Measured: hour 6/hour 12/hour 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start27 Mar 2026
- Primary completion27 Mar 2027 (estimated)
- Study completion27 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control group was treated with routine treatment, and the treatment group was treated with Fu's subcutaneous needling on the basis of routine treatment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenyu Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou University of Chinese Medicine
- Responsible party
- Sponsor-investigator, Zhenyu Zhang, Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607249
- Sponsor's protocol ID
- YF2026-112-01
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Gastrointestinal Dysfunction After Knee Joint Surgery Under General Anesthesia With Floating Needle
- ClinicalTrials.gov ID
- NCT07607249
- Acronym / sponsor ID
- YF2026-112-01
- Conditions
- Gastrointestinal Dysfunction
- Keywords
- Gastrointestinal dysfunction, postoperative gastrointestinal disorder, Fu's Subcutaneous Needling, FSN, Fu's Acupuncture, FSN acupuncture Needle, Knee Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Zhenyu ZhangUniversity, hospital or other
- Collaborators
- Guangzhou University of Chinese Medicine
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 27 Mar 2027 (estimated)
- Study completion
- 27 Mar 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial was conducted to compare the clinical efficacy of Fu's subcutaneous acupuncture and western medication in the treatment of gastrointestinal dysfunction after knee surgery under general anesthesia. The difference in clinical efficacy between the Fu's subcutaneous acupuncture group and the western medication group was analyzed, and the mechanism of Fu's subcutaneous acupuncture in the treatment of gastrointestinal dysfunction after general anesthesia was further explored. It was confirmed that Fu's subcutaneous acupuncture can effectively promote postoperative gastrointestinal motility and reduce postoperative gastrointestinal discomfort. It can shorten the recovery time of gastrointestinal function, improve the quality of life of patients during the perioperative period, and explore the improvement of postoperative complications and promote the postoperative rehabilitation of patients, which is worthy of clinical application.
Detailed description
Postoperative gastrointestinal dysfunction refers to the symptoms such as abdominal distension, nausea and vomiting, constipation, and weakened or disappeared bowel sounds caused by preoperative anesthesia, postoperative fasting, use of analgesics, prolonged bed rest, and early drinking after surgery. It is a common complication of surgery. The use of opioid analgesics during and after general anesthesia can bind to the opioid receptors distributed in the presynaptic neurons of the intestinal muscle layer, resulting in the decrease of intestinal peristalsis waves and the cessation of motility, leading to the occurrence of postoperative gastrointestinal dysfunction, with an incidence of up to 81%. The delayed recovery of gastrointestinal function after surgery can lead to intestinal obstruction or paralysis, anastomotic leakage and other complications. It not only has adverse effects on the recovery process and quality of life, but also may increase the consumption of medical resources. Studies have shown that the incidence of Postoperative gastrointestinal dysfunction in abdominal surgery can be as high as 10% to 30%. In recent years, the incidence of Postoperative gastrointestinal dysfunction has not decreased significantly, but has increased by 10% in Japan. Patients with Postoperative gastrointestinal dysfunction have a longer hospital stay than those without POGD, and have more postoperative complications such as infection and postoperative intestinal obstruction, which brings a greater economic burden to patients and society. At present, a simple, convenient and effective method to restore gastrointestinal function is the key to reduce postoperative complications and rapid recovery to reduce the length of hospital stay, and it is also the key problem to be solved during the perioperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The control group was treated with routine treatment, and the treatment group was treated with Fu's subcutaneous needling on the basis of routine treatment
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Active comparator | Drug: Mosapride |
| Fu's Acupuncture group | Experimental | Device: Fu's Acupuncture group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Met the diagnostic criteria for postoperative gastrointestinal dysfunction as defined in the Clinical Practice Guidelines for the Prevention and Treatment of Postoperative Gastrointestinal Dysfunction Using Integrated Traditional Chinese and Western Medicine;
- Underwent elective knee surgery under general anesthesia;
- Had normal bowel habits prior to hospital admission;
- Were aged 18-80 years;
- Had no severe systemic comorbidities or organic gastrointestinal disorders;
Key exclusion criteria (7 listed)
- Patients with chronic diarrhea or constipation attributable to organic etiologies; those with confirmed organic lesions of the large intestine (e.g., inflammatory bowel disease, diverticulosis, or neoplasms); individuals diagnosed with malignant tumors; patients who developed postoperative complications including intra-abdominal infection, abdominal hemorrhage, or cerebrovascular events requiring transfer to the intensive care unit;
- Patients with severe cardiac, hepatic, or renal dysfunction (e.g., NYHA Class IV heart failure, Child-Pugh Class C cirrhosis, or estimated glomerular filtration rate <30 mL/min/1.73 m²);
- Patients with primary immunodeficiency disorders, active systemic infections, or uncontrolled autoimmune diseases;
- Patients with recent abdominal trauma, acute surgical abdomen, or documented hypersensitivity to any intervention-related medications or materials;
- Presence of active dermatological conditions-including macules, papules, erythema, urticaria, abrasions, lacerations, or ulcerations-at the intended site of Fu's subcutaneous needle insertion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fu's Acupuncture groupThe Fu's Acupuncture group received treatment 6 hours after the operation. One treatment session was conducted. The therapeutic effects were observed at 1 hour, 12 hours, and 36 hours after the treatment. | Device | Fu's Acupuncture group |
| MosaprideOn the basis of routine postoperative care, the patients in the control group were treated with mosapride citrate tablets (Runan Beite Pharmaceutical Co., LTD., Chinese Medicine approved number H19990317, standard: 5mg), 5mg/ time, 3 times /d. | Drug | Conventional treatment group |
Primary outcome
The first postoperative exhaust and defecation time
Time frame: 6 hours/12 hours/36 hours/72 hours
1. Exhaust time was recorded as the interval from the end of the operation to the first exhaust. 2. Defecation time was recorded as the interval from the end of surgery to the first defecation. The first postoperative exhaust and defecation time were recorded at 6 hours, 12 hours, 36 hours and 72 hours after operation
Recovery time of bowel sounds
Time frame: 6 hours /12 hours /36 hours /72 hours
Recovery time of bowel sounds: auscultation was performed 6 hours after the operation in both groups, and the bowel sounds were recorded 6 hours /12 hours /36 hours /72 hours after the operation. During abdominal auscultation, five key auscultation areas were selected: left lower abdomen, left upper abdomen, right upper abdomen, right lower abdomen and around the umbilicus (G letter shape). At least 3 minutes of auscultation per auscultation area, bowel sounds were assessed as being in the normal range only if they were heard in two or more areas at a frequency of (3-5) beats/min. The patients in the treatment group were treated with Fu's subcutaneous needling after operation, and the bowel sounds were recorded once after each treatment. Each auscultation was recorded by a special person. Postoperative bowel sound recovery time: the time between the end of surgery and the time when bowel sounds returned to normal.
2 secondary outcomes
Gastrointestinal Symptom Rating Scale, GSRS
Time frame: hour 6/hour 12/hour 36
Five-point Likert scale for abdominal distension
Time frame: hour 6/hour 12/hour 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fu's Acupuncture group and Mosapride in people with Gastrointestinal Dysfunction, run by Zhenyu Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first postoperative exhaust and defecation time (time frame: 6 hours/12 hours/36 hours/72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.