Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair
Evaluating the Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair
調査の概要
状態
詳細な説明
Inguinal hernia repair is one of the most common surgical conditions encountered in primary care settings. Globally, around 20 million groin hernia repairs are performed each year. Surgical procedure is the gold standard treatment for inguinal hernia repair.
Laparoscopic hernioplasty is suitable for patients with inguinal hernia who can undergo general anesthesia, especially in cases like hernia recurrence after open repair, bilateral hernias, and simultaneous procedures like cholecystectomy.
Although open mesh repair has already demonstrated a low recurrence rate, laparoscopic mesh repair has become increasingly popular in recent years due to its benefits, including a better view of the groin anatomy, ease in addressing bilateral hernias, and superior cosmetic outcomes. The two most widely used laparoscopic mesh repair techniques are Totally Extra peritoneal (TEP) and Trans abdominal Preperitoneal (TAPP) repair, both of which are based on the myopectineal orifice theory. The key difference between TEP and TAPP lies in the method used to access the preperitoneal space.
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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Cairo、エジプト、12613
- Cairo University
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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:
- Patients aged from18 to 70 years.
- Both sexes.
- Patients were diagnosed with all types of inguinal hernia who are candidates for elective trans-abdominal Preperitoneal (TAPP) repair.
Exclusion Criteria:
- Previous history of pelvic or lower abdominal surgery.
- Coagulopathy.
- Any condition contraindicating laparoscopic surgery.
- Patients with complicated hernia (irreducible/incarcerated or obstructed/strangulated hernia).
- Active infections.
- Uncorrected medical comorbidities.
- Bilateral inguinal hernia either preoperative or intraoperative diagnosis.
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：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group A
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
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Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
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実験的：Group B
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.
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Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.
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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 |
|---|---|---|
|
Incidence of patients suffering from Seroma
時間枠：6 months post-procedure
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Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.
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6 months post-procedure
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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 |
|---|---|---|
|
Degree of pain
時間枠：24 hours post-procedure
|
Pain was assessed using Visual Analogue Scale (VAS) in which the pain score is defined from 0 (no pain) to 10 (maximum pain) at rest and during activity recorded at similar intervals.
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24 hours post-procedure
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Degree of patient satisfaction
時間枠：24 hours post-procedure
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Degree of patient satisfaction was assessed using 3-likert point scale where (1, Neutral; 2, Satisfied; 3, Very satisfied)
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24 hours post-procedure
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Measurement of operative time
時間枠：Till closure of the skin (Up to 60 minutes).
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Measurement of operative time was done from skin incision to closure.
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Till closure of the skin (Up to 60 minutes).
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Incidence of recurrence
時間枠：6 months post-procedure
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Incidence of recurrence of hernia was assessed during follow-up visits.
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6 months post-procedure
|
協力者と研究者
スポンサー
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
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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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