Enhanced Recovery Versus Standard Care After Emergency Abdominal Surgery in Patients Requiring Emergency Laparotomy
Comparison of Enhanced Recovery Protocol After Surgery Versus Conventional Care in Emergency Laparotomy
This study aims to compare an Enhanced Recovery After Surgery (ERAS) protocol with conventional postoperative care in adults undergoing emergency laparotomy for intestinal obstruction or intestinal perforation.
The main question this study aims to answer is:
• Does the ERAS protocol reduce surgical site infections compared with conventional care after emergency laparotomy?
Researchers will also compare other recovery outcomes between the two groups, including length of hospital stay, occurrence of paralytic ileus (temporary loss of bowel function), time to first bowel movement, and time to start taking fluids by mouth after surgery.
A total of 102 participants will be enrolled and randomly assigned to one of two groups. One group will receive postoperative care according to the ERAS protocol, while the other group will receive conventional postoperative care. All participants will undergo emergency laparotomy using standard surgical and anesthetic techniques.
Participants will:
- Undergo emergency laparotomy for intestinal obstruction or intestinal perforation.
- Receive either ERAS-based postoperative care or conventional postoperative care.
- Be monitored during their hospital stay for recovery and postoperative complications.
- Be assessed for bowel function recovery, ability to tolerate oral fluids, and length of hospital stay.
- Be followed for 30 days after surgery to determine whether a surgical site infection develops.
The researchers hypothesize that patients managed with the ERAS protocol will have a lower frequency of surgical site infections and improved postoperative recovery compared with those receiving conventional care.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Punjab Province
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Muzaffargarh、Punjab Province、パキスタン、34200
- Recep Tayyip Erdogan Hospital Muzaffargarh
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参加基準
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
説明
Inclusion Criteria:
- acute intestinal obstruction or intestinal perforation
- planned for emergency laparotomy
Exclusion Criteria:
- Pregnant women
- Patients on chronic steroids
- Chronic obstructive pulmonary disease
- Malignant ulcers confirmed by histopathological examination
- laparoscopic surgeries
- Acute abdominal trauma
- Patients who require postoperative intensive care unit (ICU) care
研究計画
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：ERAS Protocol Group
Participants undergoing emergency laparotomy will receive postoperative care according to the Enhanced Recovery After Surgery (ERAS) protocol.
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A standardized multimodal perioperative care pathway applied to patients undergoing emergency laparotomy.
The protocol includes pre-defined components for preoperative optimization, intraoperative management, and postoperative care.
Postoperative elements include early mobilization, early initiation of oral fluids and diet, optimized multimodal analgesia, early removal of tubes/drains when appropriate, and structured fluid management.
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アクティブコンパレータ：Conventional Care Group
Participants undergoing emergency laparotomy will receive standard postoperative care as routinely practiced in the surgical unit.
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Standard postoperative management routinely practiced in the surgical unit for patients undergoing emergency laparotomy.
Care includes traditional postoperative monitoring, routine analgesia, delayed initiation of oral intake, standard mobilization practices, and conventional fluid and supportive management.
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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 |
|---|---|---|
|
Surgical Site Infection
時間枠：From enrollment within 30 days postoperatively
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Frequency of surgical site infection (superficial and deep) occurring within 30 days after emergency laparotomy will be assessed and compared between the Enhanced Recovery After Surgery (ERAS) group and the conventional care group.
Surgical site infection will be defined and classified according to standard surgical infection criteria as specified in the study protocol
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From enrollment within 30 days postoperatively
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hospital Stay
時間枠：From surgery to discharge within 30 days
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Length of hospital stay will be measured in days from the day of surgery until final disposition (discharge or death).
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From surgery to discharge within 30 days
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Paralytic Ileus
時間枠：From surgery till hospital stay within 30 days postoperatively
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Incidence of postoperative paralytic ileus defined as presence of abdominal distension with absence of bowel sounds on clinical examination (auscultation for at least one minute).
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From surgery till hospital stay within 30 days postoperatively
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Time to First Stool
時間枠：From surgery till hospital stay until discharge within 30 days postoperatively
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Time (in days) from surgery to passage of first postoperative stool, indicating return of bowel function.
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From surgery till hospital stay until discharge within 30 days postoperatively
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Time to First Fluid Diet
時間枠：Postoperatively during hospital stay till discharge within 30 days postoperatively
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Time (in days) from surgery to initiation and tolerance of first oral fluid intake postoperatively.
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Postoperatively during hospital stay till discharge within 30 days postoperatively
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協力者と研究者
捜査官
- スタディチェア：Muhammad I Seerat, FCPS、Recep Tayyip Erdogan Hospital Muzaffargarh
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- U1111-1342-1146
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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