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Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery (ABP-CS)

27. juni 2026 opdateret af: Jingyuan,Xu, Southeast University, China

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.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Zhongda Hospital, Southeast University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Anti-Bloating Patch Group
Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery.
Andet: Anti-Bloating Patch
Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
Andet: Standard Perioperative Care
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.
Aktiv komparator: Control Group
Participants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment.
Andet: Standard Perioperative Care
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Gastric Bubble Area on Postoperative Day 1
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastric Bubble Area on Postoperative Day 1
Tidsramme: Postoperative Day 1
Absolute gastric bubble area measured on chest radiographs using ImageJ software.
Postoperative Day 1
Percentage Change in Gastric Bubble Area
Tidsramme: Postoperative Day 1
Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
Postoperative Day 1
Abdominal Distension Score
Tidsramme: Postoperative Day 1
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.
Postoperative Day 1
Time to First Flatus
Tidsramme: From surgery until first flatus, up to hospital discharge
Time from completion of surgery to first passage of flatus.
From surgery until first flatus, up to hospital discharge
Time to First Bowel Movement
Tidsramme: From surgery until first bowel movement, up to hospital discharge
Time from completion of surgery to first bowel movement.
From surgery until first bowel movement, up to hospital discharge
Gastric Drainage Volume
Tidsramme: Within 24 hours after surgery
Total gastric drainage volume recorded during the first 24 postoperative hours.
Within 24 hours after surgery
Time to Oral Feeding
Tidsramme: Through hospital discharge, an average of 10 days
Time from completion of surgery to first oral intake, measured in hours.
Through hospital discharge, an average of 10 days
Intensive Care Unit Length of Stay
Tidsramme: Through ICU discharge, an average of 3 days
Duration of stay in the intensive care unit, measured in hours or days.
Through ICU discharge, an average of 3 days
Postoperative Hospital Length of Stay
Tidsramme: Through hospital discharge, an average of 10 days
Duration of hospitalization after surgery, measured in days.
Through hospital discharge, an average of 10 days
Incidence of Patch-Related Adverse Events
Tidsramme: From patch application through hospital discharge, an average of 10 days
Incidence of adverse events related to anti-bloating patch application, including skin irritation, rash, itching, allergic reactions, or other treatment-related adverse events.
From patch application through hospital discharge, an average of 10 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southeast University, China

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

21. juni 2026

Først indsendt, der opfyldte QC-kriterier

27. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2026ZDSYLL231-P01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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