3DMax™ MID解剖メッシュ（BD、米国）の腹腔鏡・内視鏡鼠径ヘルニア修復術における安全性と有効性 - 多施設前向き観察研究 (3DMS)
3DMax MID解剖学的メッシュ（BD, USA）を用いた腹腔鏡・内視鏡下鼠径ヘルニア修復術における安全性と有効性：多施設前向き観察コホート研究
This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice.
The primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications.
All participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Laparoendoscopic techniques such as transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) repair are widely used for the treatment of inguinal hernia and are associated with faster recovery and lower rates of chronic pain compared with open repair in appropriately selected patients. Mesh reinforcement is a key component of these procedures. Three-dimensional, anatomically contoured meshes have been developed to improve conformability to the myopectineal orifice and to provide stable coverage of the inguinal region, potentially reducing the need for additional fixation and lowering the risk of chronic postoperative pain.
The 3DMax MID Anatomical Mesh (BD, USA) is a medium-weight, macroporous, pre-shaped polypropylene mesh designed specifically for inguinal hernia repair. Its three-dimensional configuration and recoil properties are intended to facilitate correct positioning and stable coverage of the inguinal anatomy during laparoendoscopic procedures.
This multicenter, prospective, observational cohort study will include consecutive adult patients undergoing elective TAPP or TEP inguinal hernia repair in participating centers, in whom the operating surgeon has decided to use the 3DMax MID Anatomical Mesh as part of routine practice. No randomization or control group is planned, and no interventions outside standard care will be performed.
Data will be collected from medical records and structured follow-up contacts (early postoperative check, approximately 30 days, 3 months and 12 months after surgery). The primary endpoint is hernia recurrence within 12 months. Secondary endpoints include postoperative pain, groin discomfort, foreign body sensation and early or late postoperative complications. Study data will be recorded in a standardized database and analyzed descriptively to characterize the safety profile and clinical performance of the 3DMax MID Anatomical Mesh in real-world practice.
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究場所
-
-
-
Gdansk、ポーランド、80-280
- Swissmed Hospital
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-
参加基準
適格基準
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
サンプリング方法
調査対象母集団
Adult patients with primary unilateral or bilateral inguinal hernia undergoing elective laparoendoscopic (TAPP or TEP) repair with implantation of the 3DMax MID Anatomical Mesh in participating centers.
説明
Inclusion Criteria:
- Age 18 years or older
- Primary unilateral or bilateral inguinal hernia
- Scheduled for elective laparoendoscopic inguinal hernia repair (TAPP or TEP)
- Considered suitable for general anesthesia and laparoendoscopic approach by the treating surgeon
- 3DMax MID Anatomical Mesh planned for use as part of routine clinical care
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Age below 18 years
- Emergency surgery (e.g. incarcerated or strangulated hernia requiring urgent intervention)
- Contaminated or potentially contaminated surgical field
- Recurrent inguinal hernia in the same groin (previous repair with mesh or suture)
- Concomitant procedures or clinical situations in which the surgeon decides that a different mesh concept or technique is required
- Inability or unwillingness to comply with follow-up schedule (e.g. lack of telephone contact, severe cognitive impairment)
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
3DMax MID TAPP/TEP
Adult patients undergoing elective laparoendoscopic inguinal hernia repair (TAPP or TEP) with implantation of the 3DMax MID Anatomical Mesh (BD, USA) as part of routine clinical practice. No randomization or control group is used; all enrolled participants receive the same type of mesh according to the treating surgeon's standard technique. |
Implantation of a pre-shaped, medium-weight, macroporous polypropylene anatomical mesh (3DMax MID Anatomical Mesh, BD, USA) during elective laparoendoscopic inguinal hernia repair (TAPP or TEP) as part of routine clinical practice. No additional experimental procedures beyond standard surgical care are planned.
他の名前：
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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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inguinal hernia recurrence rate at 12 months
時間枠：12 months after index surgery
|
Proportion of patients with clinically and/or imaging-confirmed inguinal hernia recurrence within 12 months after the index laparoendoscopic repair with 3DMax MID Anatomical Mesh. |
12 months after index surgery
|
二次結果の測定
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 pain intensity (VAS 0-10)
時間枠：7-10 days, 30 days, 3 months and 12 months after surgery
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Postoperative pain intensity assessed using a 0-10 Visual Analog Scale (VAS) during early and late follow-up. Chronic pain will be defined as VAS ≥4 persisting beyond 3 months after surgery. |
7-10 days, 30 days, 3 months and 12 months after surgery
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Early postoperative complications (≤30 days)
時間枠：Up to 30 days after surgery
|
Incidence of early postoperative complications within 30 days after surgery, including wound infection, hematoma, seroma, urinary retention, bleeding, and other mesh- or procedure-related adverse events. |
Up to 30 days after surgery
|
|
Late postoperative complications (>30 days to 12 months)
時間枠：From >30 days to 12 months after surgery
|
Incidence of late postoperative complications occurring between 30 days and 6 months after surgery, including chronic groin pain, mesh-related complications, and reoperations in the operated groin. |
From >30 days to 12 months after surgery
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|
Groin discomfort and foreign body sensation
時間枠：7-10 days, 30 days, 3 months and 12 months after surgery
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Patient-reported groin discomfort, stiffness and foreign body sensation in the operated region, assessed using standardized questions or Likert-type scales (0-10) during follow-up contacts. |
7-10 days, 30 days, 3 months and 12 months after surgery
|
協力者と研究者
捜査官
捜査官
- スタディチェア：Maciej Śmietański, Prof.、LUX MED Hospital in Gdańsk
- 主任研究者：Mateusz Zamkowski, MD, PhD、LUX MED Hospital in Gdańsk
出版物と役立つリンク
一般刊行物
- Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.
- Zamkowski M, S Mietanski M, Franczak P, Gorski D, Grabias J, Janik M, Krol A, Mitura K, Medras O, Nawacki L, Romanczuk M, Rymkiewicz P, Saluk S, Sroczynski P, Sulkowski L, Wieczorek D, Wlodarczyk M. MEsh FIxation STudy in Laparoendoscopic Repair of M3 Inguinal Hernias: Multicenter, Double-blind, Randomized Controlled Trial-MEFISTO Trial. Ann Surg. 2025 Jun 1;281(6):921-927. doi: 10.1097/SLA.0000000000006669. Epub 2025 Feb 13.
- Zamkowski M, Smietanski M. MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial-study protocol for a MEFI Trial. Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.
- Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Putko M, Smietanski M. Mechanical stability of new-generation meshes for M3 inguinal hernia repair: experimental pressure chamber testing of SWING-Mesh and 3DMax MID Anatomical Mesh. Wideochir Inne Tech Maloinwazyjne. 2025 Oct 29;20(4):409-414. doi: 10.20452/wiitm.2025.17990. eCollection 2025 Dec 29.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- 3DMID-PL
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
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