RCT Ventralex vs Onlay Mesh in Incisional Hernias
キーワード
概要
説明
Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.
Repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.
日付
最終確認済み: | 03/31/2020 |
最初に提出された: | 04/18/2020 |
提出された推定登録数: | 04/20/2020 |
最初の投稿: | 04/23/2020 |
最終更新が送信されました: | 04/20/2020 |
最終更新日: | 04/23/2020 |
実際の研究開始日: | 08/31/2020 |
一次完了予定日: | 09/29/2022 |
研究完了予定日: | 09/29/2023 |
状態または病気
介入/治療
Device: Ventralex
Device: Progrip
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: Ventralex Repair with Ventralex patch in sublay position | Device: Ventralex Repair of the hernia by a Ventralex patch in sublay position |
Active Comparator: Progrip Repair with Progrip in Onlay position | Device: Progrip Repair of the hernia by a Progrip mesh in onlay position |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - Hernia defect 1-4 cm - Incisional hernia or recurrent hernia after previous primary hernia repair - BMI <35 - Age 18-100 years Exclusion Criteria: - Defect size>4 cm - Ongoing pregnancy - BMI>35 - Primary hernia |
結果
主な結果の測定
1. Recurrence rate [One year]
二次的な結果の測定
1. Rate ofntra- and postoperative complications [30 days]
2. Rate of seroma [one year]
3. Persisting postoperative pain [One year]
4. Sick leave [30 days]