Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair (IMFC)
Prospective Comparative Evaluation of the Integrated Mesh-Fascial Closure (IMFC) Technique Versus Standard Closure of the Abdominal Wall: A Quasi-Experimental, Non-Randomized Study
This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy.
In one group, the abdominal wall is closed using the standard technique, in which a polypropylene mesh is fixed independently from the fascial suture. In the other group, Integrated Mesh-Fascial Closure (IMFC) is used, a standardized execution of the technique of mesh incorporation into the fascial closure described by Jamal et al (Hernia, 2013).
The choice of technique is made by the patient after receiving information about both options and providing informed consent. Participants will be followed clinically and with imaging for 18 to 24 months to evaluate the safety, technical feasibility, and reproducibility of the IMFC technique, and to determine the incidence of hernia recurrence in both groups.
調査の概要
状態
詳細な説明
Incisional hernia is one of the most frequent complications of abdominal surgery, with a reported incidence of 10-20% after laparotomy, and recurrence rates after mesh repair reaching 20-30% in long-term follow-up. In conventional techniques, primary fascial closure and mesh fixation are performed as two mechanically independent steps, concentrating tension on the suture line during the acute postoperative period.
The Integrated Mesh-Fascial Closure (IMFC) technique integrates a macroporous polypropylene mesh within a continuous fascial suture line (pattern: mesh → right fascial edge → left fascial edge → mesh), aiming to distribute tensile load simultaneously between the fascia and the prosthesis, potentially reducing the incidence of hernia recurrence compared to standard closure. The principle of incorporating the mesh into the fascial closure was described by Jamal et al in a retrospective series of 72 patients. IMFC standardizes its execution (suture material, 5-mm bites in mesh and fascia, anchoring of the suture line in healthy aponeurosis, and optional minimal peripheral fixation) and evaluates it prospectively against standard closure.
This is a prospective, comparative, quasi-experimental (non-randomized) study conducted at a single center (Hospital Zonal General de Agudos "Dr. Mario V. Larrain," Berisso, Argentina). Eligible patients choose, after informed consent, between standard mesh closure (Group A) or IMFC (Group B). Both groups follow the same clinical and imaging follow-up schedule (days 7, 15, 30; months 2, 6, 12, 18; and a final visit between 18 and 24 months).
The study is designed as an initial, hypothesis-generating comparison of safety, technical feasibility, and reproducibility across surgeons, intended to support a future randomized trial.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Facundo B Mattano, MD
- 電話番号：+54 9 221 611-7976
- メール：mattanofacundo@outlook.com
研究連絡先のバックアップ
- 名前：Emiliano D Gargiulo, MD
- 電話番号：+54 2215371371
研究場所
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-
Buenos Aires
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Berisso、Buenos Aires、アルゼンチン、1923
- 募集
- Hospital Zonal General de Agudos "Dr. Mario V. Larrain
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コンタクト：
- Facundo B Mattano, MD
- 電話番号：+54 9 2216117976
- メール：mattanofacundo@outlook.com
-
コンタクト：
- Emiliano D Gargiulo, MD
- 電話番号：+54 9 221 5371371
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults older than 18 years of age
- Patients with incisional (ventral) hernia
- Patients with recurrent incisional hernia
- Incisional hernias with a diameter greater than 4 cm
- Patients undergoing laparotomy with an indication for prophylactic mesh placement
Exclusion Criteria:
- Active surgical site infection
- Overt abdominal contamination
- Tissue necrosis or inability to achieve primary fascial closure
- Non-correctable loss of domain
- Pregnant women or women of childbearing potential planning pregnancy or not using contraception during the follow-up period
- Patients belonging to vulnerable populations, in accordance with Law 15.462 and applicable ethical guidelines
- Active oncologic disease (patients with a cured oncologic history may be included)
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：処理
- 割り当て：非ランダム化
- 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 |
|---|---|
|
アクティブコンパレータ：Standard Mesh Closure
Conventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture |
Macroporous polypropylene mesh (FILAPROP™/MERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique. |
|
実験的：Integrated Mesh-Fascial Closure - IMFC
Fascial closure using the Integrated Mesh-Fascial Closure (IMFC) technique: the mesh is incorporated within the trajectory of a single continuous fascial suture (pattern: mesh → right fascial edge → left fascial edge → mesh |
Same materials integrated into a single continuous suture line using the IMFC technique. |
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 |
|---|---|---|
|
Recurrence rate of incisional hernia
時間枠：18-24 months (final follow-up visit)
|
Proportion of participants with hernia recurrence, assessed by clinical physical examination and abdominal wall ultrasound, performed in all participants at 6 months and at the final visit (18-24 months). All ultrasound evaluations performed by the same sonographer throughout the study; the sonographer is aware of study participation but blinded to the specific surgical technique (IMFC vs. standard closure) received by each participant. |
18-24 months (final follow-up visit)
|
|
Rate of Major Intraoperative and Postoperative Complications
時間枠：Throughout study participation (up to 24 months)
|
Proportion of participants experiencing a serious adverse event (SAE), defined per ICH E6(R3) as death, a life-threatening event, hospitalization or prolongation of hospitalization, persistent or significant disability, or an unplanned surgical reintervention. Postoperative complications additionally graded using the Clavien-Dindo classification system (Grade I-V) to assess severity. |
Throughout study participation (up to 24 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Operative time and fascial closure time
時間枠：Intraoperative (during the surgical procedure)
|
Total operative time (from skin incision to skin closure) and fascial closure time (from start to completion of the mesh-fascial suture line), both measured in minutes and recorded intraoperatively by the surgical team using the operating room clock. |
Intraoperative (during the surgical procedure)
|
|
Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)
時間枠：Postoperative days 7, 15, and 30
|
Self-reported postoperative pain intensity measured using the 11-point Numeric Pain Rating Scale (NRS-11), an unabbreviated verbally- or visually-administered numeric scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores indicate worse (more severe) pain. Assessed at rest. |
Postoperative days 7, 15, and 30
|
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Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)
時間枠：Up to 30 days postoperative
|
Proportion of participants with surgical site infection, seroma, wound dehiscence, or hematoma, identified by clinical examination at scheduled postoperative visits (days 7, 15, and 30) and graded according to the Clavien-Dindo classification. |
Up to 30 days postoperative
|
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Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations
時間枠：Up to 24 months (exploratory)
|
Total direct hospital costs, expressed in Argentine pesos (ARS), attributable to management of complications or unplanned reoperations, extracted from institutional administrative and billing records. Exploratory outcome; not powered for formal statistical comparison between groups. |
Up to 24 months (exploratory)
|
協力者と研究者
捜査官
- 主任研究者：Facundo B Mattano, MD、Hospital Zonal General de Agudos "Dr. Mario V. Larrain
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- IMFC-HL-2026
- DISPO-2026-226-GDEBA-DIYCTMSAL (その他の識別子：Comisión Conjunta de Investigaciones en Salud (CCIS))
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
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