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

2026年6月27日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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

研究の種類

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • Zhongda Hospital, Southeast University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Anti-Bloating Patch Group
Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery.
他の：Anti-Bloating Patch
Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
他の：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.
アクティブコンパレータ：Control Group
Participants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Gastric Bubble Area on Postoperative Day 1
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Gastric Bubble Area on Postoperative Day 1
時間枠：Postoperative Day 1
Absolute gastric bubble area measured on chest radiographs using ImageJ software.
Postoperative Day 1
Percentage Change in Gastric Bubble Area
時間枠：Postoperative Day 1
Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
Postoperative Day 1
Abdominal Distension Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Southeast University, China

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年6月21日

QC基準を満たした最初の提出物

2026年6月27日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月30日

QC基準を満たした最後の更新が送信されました

2026年6月27日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 2026ZDSYLL231-P01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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