Postoperative Gastric DistensionABP-CSNCT07677423
Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery
A study testing Anti-Bloating Patch and Standard Perioperative Care in people with Postoperative Gastric Distension and Postoperative Gastrointestinal Dysfunction, run by Southeast University, China at 1 site in China.
Trial summary
Postoperative gastric distension is a common gastrointestinal complication after cardiac surgery and may delay recovery, prolong intensive care unit (ICU) stay, and reduce patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Gastric Distension, Postoperative Gastrointestinal Dysfunction, Cardiac Surgery
- What is being tested?
- Anti-Bloating Patch and Standard Perioperative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Undergoing elective cardiac surgery
- Postoperative chest radiographs available for gastric bubble area assessment
- Able to provide written informed consent or have consent provided by a legally authorized representative
- Expected postoperative intensive care unit admission
Who cannot join
- Previous major gastrointestinal surgery affecting gastric anatomy or motility
- Known gastrointestinal obstruction, perforation, or severe gastrointestinal disease
- Severe hepatic or renal dysfunction judged unsuitable by the investigators
- Known allergy or hypersensitivity to components of the anti-bloating patch
- Participation in another interventional clinical trial within the previous 30 days
- Pregnancy or lactation
- Inability to complete study assessments or follow study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital, Southeast University
Nanjing, Jiangsu
Xu Jingyuan, MD, 025-83262550, zhongdacq804@126.com
About this study
Official title: Efficacy of an Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery: A Randomized Controlled Trial Using Quantitative Gastric Bubble Imaging Analysis
Postoperative gastric distension is a common gastrointestinal complication after cardiac surgery and may delay recovery, prolong intensive care unit (ICU) stay, and reduce patient comfort. Anti-bloating patches are widely used in clinical practice to promote gastrointestinal function recovery; however, high-quality evidence regarding their effectiveness in cardiac surgical patients remains limited.
This randomized controlled trial aims to evaluate the efficacy and safety of an anti-bloating patch in reducing postoperative gastric distension after cardiac surgery. Adult patients undergoing cardiac surgery will be randomly assigned to receive either standard perioperative care alone or standard perioperative care plus anti-bloating patch therapy. Gastric bubble area will be quantitatively measured using chest radiographs and image analysis software.
Read more
The primary outcome is the change in gastric bubble area on postoperative day 1 compared with baseline. Secondary outcomes include gastric bubble area on postoperative day 1, percentage change in gastric bubble area, abdominal distension score, time to first flatus, time to first bowel movement, gastric drainage volume, time to oral feeding, ICU length of stay, postoperative hospital length of stay, and patch-related adverse events.
The results of this study may provide evidence for the use of anti-bloating patches as an adjunctive intervention to enhance postoperative gastrointestinal recovery in patients undergoing cardiac surgery.
Read the detailed description
Background Postoperative gastrointestinal dysfunction is frequently observed after cardiac surgery because of surgical stress, cardiopulmonary bypass, anesthesia, opioid administration, and prolonged bed rest. Gastric distension may contribute to patient discomfort, delayed gastrointestinal recovery, prolonged hospitalization, and increased healthcare utilization. Although anti-bloating patches are commonly used as a complementary intervention in perioperative care, evidence regarding their efficacy in cardiac surgery patients remains insufficient.
Objective To evaluate the clinical efficacy and safety of anti-bloating patch therapy for postoperative gastric distension in patients undergoing cardiac surgery and to establish an objective imaging-based method for quantitative assessment of gastric bubble area.
Methods This is a prospective, randomized, controlled, single-center clinical trial. A total of 150 adult patients undergoing elective cardiac surgery will be enrolled and randomly assigned in a 1:1 ratio to either an anti-bloating patch group or a control group.
Participants in the control group will receive standard perioperative management. Participants in the intervention group will receive anti-bloating patch therapy in addition to standard perioperative management.
Chest radiographs obtained on the day of surgery and on postoperative day 1 will be analyzed using ImageJ software. Gastric bubble area will be independently measured by trained investigators according to a predefined protocol
- Conditions
- Postoperative Gastric Distension, Postoperative Gastrointestinal Dysfunction, Cardiac Surgery
- Being tested
- Anti-Bloating Patch, Standard Perioperative Care
- Keywords
- Anti-Bloating Patch, Postoperative Gastric Distension, Gastric Bubble Area, Cardiac Surgery, Gastrointestinal Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Bloating PatchOther
Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
Standard Perioperative CareOther
Standard perioperative management following cardiac surgery, including routine monitoring, fluid management, nutritional support, pain control, gastrointestinal function assessment, and other standard treatments as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Anti-Bloating Patch Group | Experimental | Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery. Receives: Other: Anti-Bloating Patch; Other: Standard Perioperative Care |
| Control Group | Active comparator | Participants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment. Receives: Other: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastric Bubble Area on Postoperative Day 1
Change in gastric bubble area measured on chest radiographs from the day of surgery to postoperative day 1. Gastric bubble area will be quantified using ImageJ software and calculated as: postoperative day 1 gastric bubble area minus baseline gastric bubble area measured on the day of surgery.
Measured: Postoperative Day 1
Secondary outcomes (10)
Gastric Bubble Area on Postoperative Day 1
Absolute gastric bubble area measured on chest radiographs using ImageJ software.
Measured: Postoperative Day 1
Percentage Change in Gastric Bubble Area
Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
Measured: Postoperative Day 1
Abdominal Distension Score
Patient-reported abdominal distension severity assessed using a Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no abdominal distension and 10 indicates the worst imaginable abdominal distension. Higher scores indicate more severe abdominal distension.
Measured: Postoperative Day 1
Time to First Flatus
Time from completion of surgery to first passage of flatus.
Measured: From surgery until first flatus, up to hospital discharge
Time to First Bowel Movement
Time from completion of surgery to first bowel movement.
Measured: From surgery until first bowel movement, up to hospital discharge
Gastric Drainage Volume
Total gastric drainage volume recorded during the first 24 postoperative hours.
Measured: Within 24 hours after surgery
Time to Oral Feeding
Time from completion of surgery to first oral intake, measured in hours.
Measured: Through hospital discharge, an average of 10 days
Intensive Care Unit Length of Stay
Duration of stay in the intensive care unit, measured in hours or days.
Measured: Through ICU discharge, an average of 3 days
Postoperative Hospital Length of Stay
Duration of hospitalization after surgery, measured in days.
Measured: Through hospital discharge, an average of 10 days
Incidence of Patch-Related Adverse Events
Incidence of adverse events related to anti-bloating patch application, including skin irritation, rash, itching, allergic reactions, or other treatment-related adverse events.
Measured: From patch application through hospital discharge, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Gastric DistensionStudies 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
- Participants will be randomly assigned in a 1:1 ratio to either the anti-bloating patch group or the control group. The intervention group will receive anti-bloating patch treatment in addition to standard perioperative care, while the control group will receive standard perioperative care alone. Outcomes will be compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677423
- Sponsor's protocol ID
- 2026ZDSYLL231-P01
- Acronym
- ABP-CS
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results may be made available upon reasonable request to the corresponding investigator after publication of the primary study results, subject to institutional approval and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery: A Randomized Controlled Trial Using Quantitative Gastric Bubble Imaging Analysis
- ClinicalTrials.gov ID
- NCT07677423
- Acronym / sponsor ID
- ABP-CS / 2026ZDSYLL231-P01
- Conditions
- Postoperative Gastric Distension, Postoperative Gastrointestinal Dysfunction, Cardiac Surgery
- Keywords
- Anti-Bloating Patch, Postoperative Gastric Distension, Gastric Bubble Area, Cardiac Surgery, Gastrointestinal Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Jun 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.
Postoperative gastric distension is a common gastrointestinal complication after cardiac surgery and may delay recovery, prolong intensive care unit (ICU) stay, and reduce patient comfort. Anti-bloating patches are widely used in clinical practice to promote gastrointestinal function recovery; however, high-quality evidence regarding their effectiveness in cardiac surgical patients remains limited.
This randomized controlled trial aims to evaluate the efficacy and safety of an anti-bloating patch in reducing postoperative gastric distension after cardiac surgery. Adult patients undergoing cardiac surgery will be randomly assigned to receive either standard perioperative care alone or standard perioperative care plus anti-bloating patch therapy. Gastric bubble area will be quantitatively measured using chest radiographs and image analysis software.
The primary outcome is the change in gastric bubble area on postoperative day 1 compared with baseline. Secondary outcomes include gastric bubble area on postoperative day 1, percentage change in gastric bubble area, abdominal distension score, time to first flatus, time to first bowel movement, gastric drainage volume, time to oral feeding, ICU length of stay, postoperative hospital length of stay, and patch-related adverse events.
The results of this study may provide evidence for the use of anti-bloating patches as an adjunctive intervention to enhance postoperative gastrointestinal recovery in patients undergoing cardiac surgery.
Detailed description
Background Postoperative gastrointestinal dysfunction is frequently observed after cardiac surgery because of surgical stress, cardiopulmonary bypass, anesthesia, opioid administration, and prolonged bed rest. Gastric distension may contribute to patient discomfort, delayed gastrointestinal recovery, prolonged hospitalization, and increased healthcare utilization. Although anti-bloating patches are commonly used as a complementary intervention in perioperative care, evidence regarding their efficacy in cardiac surgery patients remains insufficient.
Objective To evaluate the clinical efficacy and safety of anti-bloating patch therapy for postoperative gastric distension in patients undergoing cardiac surgery and to establish an objective imaging-based method for quantitative assessment of gastric bubble area.
Methods This is a prospective, randomized, controlled, single-center clinical trial. A total of 150 adult patients undergoing elective cardiac surgery will be enrolled and randomly assigned in a 1:1 ratio to either an anti-bloating patch group or a control group.
Participants in the control group will receive standard perioperative management. Participants in the intervention group will receive anti-bloating patch therapy in addition to standard perioperative management.
Chest radiographs obtained on the day of surgery and on postoperative day 1 will be analyzed using ImageJ software. Gastric bubble area will be independently measured by trained investigators according to a predefined protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the anti-bloating patch group or the control group. The intervention group will receive anti-bloating patch treatment in addition to standard perioperative care, while the control group will receive standard perioperative care alone. Outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Anti-Bloating Patch Group | Experimental | Other: Anti-Bloating Patch, Other: Standard Perioperative CareParticipants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery. |
| Control Group | Active comparator | Other: Standard Perioperative CareParticipants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Undergoing elective cardiac surgery
- Postoperative chest radiographs available for gastric bubble area assessment
- Able to provide written informed consent or have consent provided by a legally authorized representative
- Expected postoperative intensive care unit admission
Key exclusion criteria (7 listed)
- Previous major gastrointestinal surgery affecting gastric anatomy or motility
- Known gastrointestinal obstruction, perforation, or severe gastrointestinal disease
- Severe hepatic or renal dysfunction judged unsuitable by the investigators
- Known allergy or hypersensitivity to components of the anti-bloating patch
- Participation in another interventional clinical trial within the previous 30 days
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 |
|---|---|---|
| Anti-Bloating PatchParticipants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery. | Other | Anti-Bloating Patch Group |
| Standard Perioperative CareStandard perioperative management following cardiac surgery, including routine monitoring, fluid management, nutritional support, pain control, gastrointestinal function assessment, and other standard treatments as clinically indicated. | Other | Anti-Bloating Patch Group, Control Group |
Primary outcome
Change in Gastric Bubble Area on Postoperative Day 1
Time frame: Postoperative Day 1
Change in gastric bubble area measured on chest radiographs from the day of surgery to postoperative day 1. Gastric bubble area will be quantified using ImageJ software and calculated as: postoperative day 1 gastric bubble area minus baseline gastric bubble area measured on the day of surgery.
10 secondary outcomes
Gastric Bubble Area on Postoperative Day 1
Time frame: Postoperative Day 1
Percentage Change in Gastric Bubble Area
Time frame: Postoperative Day 1
Abdominal Distension Score
Time frame: Postoperative Day 1
Time to First Flatus
Time frame: From surgery until first flatus, up to hospital discharge
Time to First Bowel Movement
Time frame: From surgery until first bowel movement, up to hospital discharge
Gastric Drainage Volume
Time frame: Within 24 hours after surgery
Time to Oral Feeding
Time frame: Through hospital discharge, an average of 10 days
Intensive Care Unit Length of Stay
Time frame: Through ICU discharge, an average of 3 days
Postoperative Hospital Length of Stay
Time frame: Through hospital discharge, an average of 10 days
Incidence of Patch-Related Adverse Events
Time frame: From patch application through hospital discharge, an average of 10 days
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 30 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results may be made available upon reasonable request to the corresponding investigator after publication of the primary study results, subject to institutional approval and applicable data protection regulations.
Related trials for Postoperative Gastric Distension
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Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
Delayed Gastric Emptying, Postoperative Nausea and Vomiting
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Bloating Patch and Standard Perioperative Care in people with Postoperative Gastric Distension and Postoperative Gastrointestinal Dysfunction, run by Southeast University, China 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 5 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: opening soon, as of the sponsor's last update on 30 Jun 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?
Contact Xu Jingyuan, Director (025-83262550, zhongdacq804@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastric Bubble Area on Postoperative Day 1 (time frame: Postoperative Day 1). 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 30 Jun 2026.