Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery

NCT07677423 | Not Yet Recruiting

• 1 other identifier: 2026ZDSYLL231-P01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Gastric Distension; Postoperative Gastrointestinal Dysfunction; Cardiac Surgery

Keywords

Anti-Bloating Patch; Postoperative Gastric Distension; Gastric Bubble Area; Cardiac Surgery; Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative Day 1

Secondary Outcomes (10)

• Gastric Bubble Area on Postoperative Day 1

  Postoperative Day 1

• Percentage Change in Gastric Bubble Area

  Postoperative Day 1

• Abdominal Distension Score

  Postoperative Day 1

• Time to First Flatus

  From surgery until first flatus, up to hospital discharge

• Time to First Bowel Movement

  From surgery until first bowel movement, up to hospital discharge

Study Arms (2)

Anti-Bloating Patch Group

EXPERIMENTAL

Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery.

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.

Other: Standard Perioperative Care

Interventions

Anti-Bloating Patch OTHER

Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.

Anti-Bloating Patch Group

Standard Perioperative Care OTHER

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.

Anti-Bloating Patch Group; Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Location

Central Study Contacts

Xu Jingyuan, Director

CONTACT

025-83262550; zhongdacq804@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and investigators are aware of group assignments. Outcome assessment of gastric bubble area will be performed using standardized imaging analysis procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and ending 5 years after publication.
• Access Criteria: Access to de-identified individual participant data, study protocol, statistical analysis plan, and informed consent form will be provided to qualified researchers whose proposed use of the data has been approved by the principal investigator and the sponsoring institution. Requests should include a methodologically sound research proposal. Data will be shared for the purpose of achieving the aims outlined in the approved proposal and in accordance with applicable ethical and data protection requirements.

Locations

CN (1)