Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

27. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Anti-Bloating Patch Group
Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery.
Sonstiges: Anti-Bloating Patch
Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
Sonstiges: 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.
Aktiver Komparator: Control Group
Participants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Gastric Bubble Area on Postoperative Day 1
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Gastric Bubble Area on Postoperative Day 1
Zeitfenster: Postoperative Day 1
Absolute gastric bubble area measured on chest radiographs using ImageJ software.
Postoperative Day 1
Percentage Change in Gastric Bubble Area
Zeitfenster: Postoperative Day 1
Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
Postoperative Day 1
Abdominal Distension Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Southeast University, China

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

21. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2026ZDSYLL231-P01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren