Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT) (PREEMPT)
2026年8月5日 更新者：Andrea Divizia、University of Rome Tor Vergata
PRophylactic mEsh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT): A Multicenter Randomized Clinical Trial
The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy.
Participants will be randomized in a 1:1 ratio.
The primary endpoint is the incidence of incisional hernia at 1 year.
Secondary endpoints include postoperative complications, surgical site occurrences, pain, operative time, hospital stay, morbidity, mortality, quality of life, and long-term hernia incidence.
調査の概要
状態
まだ募集していません
詳細な説明
Incisional hernia (IH) is a frequent complication after midline laparotomy, with rates up to 50-70% in high-risk or emergency settings. Emergency procedures are particularly prone to IH due to contamination and suboptimal conditions. Prophylactic mesh reinforcement has been shown to significantly reduce IH rates in elective surgery without increasing wound morbidity, but evidence in emergency settings is scarce. Biosynthetic meshes, with favorable safety and cost profiles in contaminated fields, may offer an effective preventive strategy.
The PREEMPT trial is a multicenter, randomized (1:1) controlled study including adult patients undergoing emergency midline laparotomy. Eligible patients will be randomized to prophylactic onlay biosynthetic mesh reinforcement versus primary suture closure. The primary outcome is the incidence of incisional hernia at 1 year. Secondary outcomes include postoperative complications, surgical site occurrences, pain (VAS), operative time, length of hospital stay, 30-day morbidity and mortality, readmission and reoperation rates, and long-term quality of life (SF-36) and hernia incidence at 2 and 3 years.
The PREEMPT trial is a multicenter randomized clinical trial of patients undergoing emergency laparotomy. We aim to evaluate whether prophylactic bio-synthetic mesh reinforcement could reduce the incidence of incisional hernia in patients undergoing emergency midline laparotomy compared with primary suture closure.
研究の種類
介入
入学 (推定)
189
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
- 名前：Andrea Martina Guida, MD
- 電話番号：+390620908126
- メール：andreamartina.guida@ptvonline.it
研究連絡先のバックアップ
- 名前：Andrea Divizia, MD, PhD
- メール：andrea.divizia@ptvonline.it
研究場所
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Roma、イタリア
- Policlinico di Roma Tor Vergata
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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:
All adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice.
Exclusion Criteria:
- Age < 18 years
- Minimally invasive surgery (laparoscopic or robotic approaches)
- Elective surgery
- Surgery requiring an open abdomen and its closure
- Fecal peritonitis
- Previous midline laparotomy
- Pregnancy or breastfeeding
- Conditions that would impair the possibility of understanding and giving of informed consent.
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：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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Mesh-repair group
Patients randomized to this arm will receive prophylactic onlay placement of a biosynthetic mesh (poly-4-hydroxybutyrate mesh) to reinforce the abdominal wall closure at the time of laparotomy closure, in addition to standard surgical closure.
A minimum overlap of 3 cm on all sides of the incision will be ensured.
Mesh fixation will be achieved with four sutures placed at the cardinal points only.
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A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
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アクティブコンパレータ：Direct suture group
Patients randomized to this arm will receive standard abdominal wall closure according to European Hernia Society (EHS) guidelines: a slowly absorbable running suture will be used in all centers, employing a continuous small-bites technique.
Tissue bites of 5-9 mm from the wound edges will incorporate the aponeurosis only, with stitches placed 5 mm apart to ensure uniform tension distribution, aiming for a suture length to wound length ratio of at least 4:1.
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Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.
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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 |
|---|---|---|
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Incidence of incisional hernia at 12 months after laparotomy
時間枠：12 months after laparotomy
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The primary outcome is the occurrence of incisional hernia within 12 months after laparotomy, assessed by clinical examination and/or imaging according to the study protocol.
The incidence of incisional hernia will be compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.
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12 months after laparotomy
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative complications
時間枠：Within 30 days after surgery
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Postoperative complications will be assessed according to the Clavien-Dindo classification.
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Within 30 days after surgery
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Incidence of surgical site infection
時間枠：Within 30 days after surgery
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The incidence of surgical site infection (superficial, deep, and organ-space infection) occurring after laparotomy will be evaluated and compared between treatment groups
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Within 30 days after surgery
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Incidence of surgical site occurrences after emergency laparotomy
時間枠：Within 30 days after surgery
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The incidence of surgical site occurrences (SSO), including surgical site infection, seroma, wound dehiscence, hematoma, and other wound-related complications, will be assessed and compared between treatment groups.
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Within 30 days after surgery
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Incidence of surgical site occurrences requiring procedural intervention (SSOPI)
時間枠：Within 30 days after surgery
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The incidence of surgical site occurrences requiring procedural intervention (SSOPI) will be assessed.
SSOPI include surgical site occurrences requiring invasive treatment, such as wound drainage, percutaneous intervention, surgical debridement, or other procedural management.
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Within 30 days after surgery
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Incidence of incisional hernia at 2 and 3 years after surgery
時間枠：At 2 and 3 years after surgery
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The long-term incidence of incisional hernia will be assessed at 2 and 3 years after laparotomy and compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.
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At 2 and 3 years after surgery
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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 |
|---|---|---|
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Operative time
時間枠：Intraoperatively
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Operative time will be measured from skin incision to completion of skin closure and compared between patients undergoing prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure.
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Intraoperatively
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Readmission and reoperation rates
時間枠：Within 30 days after surgery
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The rates of unplanned hospital readmission and reoperation after the index surgery will be assessed and compared between treatment groups.
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Within 30 days after surgery
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30-day postoperative morbidity and mortality
時間枠：Within 30 days after surgery
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Thirty-day postoperative morbidity and mortality will be assessed, including the occurrence of postoperative complications and death within 30 days after the index surgery.
Postoperative complications will be recorded and compared between treatment groups.
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Within 30 days after surgery
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Postoperative pain assessed by Visual Analogue Scale (VAS)
時間枠：Postoperative days 1, 3, and 5
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Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 0-10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Pain scores will be compared between treatment groups.
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Postoperative days 1, 3, and 5
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Length of hospital stay
時間枠：Through hospital discharge, up to 30 days after surgery
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Length of hospital stay will be measured as the number of days from the date of the index surgery to hospital discharge and will be compared between treatment groups.
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Through hospital discharge, up to 30 days after surgery
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Quality of life assessed by the Short Form-36 (SF-36) questionnaire
時間枠：At 12 months after surgery
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Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Scores will be compared between treatment groups.
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At 12 months after surgery
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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。
協力者
捜査官
- 主任研究者：Andrea Divizia, MD, PhD、UOSD Chirurgia d'Urgenza, Policlinico di Roma Tor Vergata
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Depuydt M, Allaeys M, de Carvalho LA, Vanlander A, Berrevoet F. Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate? World J Surg. 2021 May;45(5):1349-1361. doi: 10.1007/s00268-020-05898-0. Epub 2021 Feb 8.
- Jairam AP, Lopez-Cano M, Garcia-Alamino JM, Pereira JA, Timmermans L, Jeekel J, Lange J, Muysoms F. Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis. BJS Open. 2020 Jun;4(3):357-368. doi: 10.1002/bjs5.50261. Epub 2020 Feb 14.
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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9月1日
一次修了 (推定)
2029年8月31日
研究の完了 (推定)
2031年8月31日
試験登録日
最初に提出
2026年7月29日
QC基準を満たした最初の提出物
2026年8月5日
最初の投稿 (実際)
2026年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月7日
QC基準を満たした最後の更新が送信されました
2026年8月5日
最終確認日
2026年7月1日
詳しくは
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。