Robotic Single Port Combined Umbilical and Inguinal Hernia Repair (CAPPUCCINOH)
Combined APProach of Umbilical ConComitant With Inguinal Hernia
調査の概要
状態
詳細な説明
The CAPPUCCINOH study (Combined APProach of Umbilical ConComitant with Inguinal Hernia Repair) is a prospective single-centre, single-arm cohort study conducted at AZ Maria Middelares, Ghent, Belgium. The study evaluates a novel surgical technique combining robotic-assisted inguinal hernia repair with concomitant umbilical hernia repair using the da Vinci Single Port (SP) system.
Building on the feasibility demonstrated in the ESPRITH study, the umbilical hernia defect is used as the single access site for the robotic procedure. Following inguinal hernia repair, the umbilical defect is repaired either by primary closure or with preperitoneal mesh reinforcement according to current guidelines and defect size.
The primary objective is to assess the safety and feasibility of this approach by evaluating operative time, technical errors, successful mesh placement, and perioperative complications. Secondary objectives include assessment of patient-reported outcomes, quality of life, body image, and hernia recurrence at one year postoperatively.
Patients will be followed for one year after surgery, with evaluations performed during hospitalization and at one month and one year postoperatively. The study aims to generate clinical evidence on the safety, effectiveness, and patient experience of robotic single-port repair for concomitant inguinal and umbilical hernias.
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：Filip Muysoms, MD, PhD
- 電話番号：+32477325710
- メール：filip.muysoms@gmail.com
研究連絡先のバックアップ
- 名前：Jolien Lansens, Sc
- 電話番号：+3292461854
- メール：Jolien.Lansens@mijnziekenhuis.be
研究場所
-
-
East-Flanders
-
Ghent、East-Flanders、ベルギー、9000
- 募集
- AZ Maria Middelares
-
コンタクト：
- Filip Muysoms, MD, PhD
- 電話番号：+32477325710
- メール：filip.muysoms@gmail.com
-
-
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:
- Adults with a primary inguinal hernia, either unilateral or bilateral, in association with a primary umbilical hernia of >1
Exclusion Criteria:
- recurrent inguinal hernia after preperitoneal repair
- irreducible scrotal hernia
- post-prostatectomy
- laparotomy in the lower abdomen
- pregnancy
- contra-indication for general anaesthesia
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：なし
- 介入モデル：単一グループの割り当て
- 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：Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
|
Robotic surgical platform used to perform single-port robotic inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site.
Robotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system.
|
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 |
|---|---|---|
|
Technical errors with the robotic system
時間枠：During surgery
|
Number and type of technical errors or device-related issues encountered during the procedure.
|
During surgery
|
|
Operative time
時間枠：During surgery
|
Total operative time from skin incision to skin closure
|
During surgery
|
|
Complication Rate
時間枠：From surgery until 1 month postoperatively
|
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
|
From surgery until 1 month postoperatively
|
|
Success rate
時間枠：From surgery until planned follow-up 1 month potoperatively
|
success rate of preperitoneal mesh placement
|
From surgery until planned follow-up 1 month potoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Image Questionnaire Score
時間枠：Preoperatively, 1 month , and 1 year postoperatively
|
Patient-reported body image assessed using the Body Image Questionnaire.
The questionnaire evaluates patient satisfaction with physical appearance and cosmetic outcomes
|
Preoperatively, 1 month , and 1 year postoperatively
|
|
EuraHS Quality of Life score
時間枠：Preoperatively, 1 month and 1 year postoperatively
|
Patient-reported quality of life assessed using the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) Questionnaire, a validated instrument evaluating pain at the hernia site, restriction of activities, and cosmetic discomfort.
The total EuraHS-QoL score ranges from 0 to 90, with lower scores indicating better quality of life and less symptom burden, and higher scores indicating worse quality of life and greater symptom burden
|
Preoperatively, 1 month and 1 year postoperatively
|
|
Number of Participants With Hernia Recurrence
時間枠：1 year postoperatively
|
Number of participants with a recurrent ventral hernia within 1 year after surgery.
Hernia recurrence will be assessed clinically and confirmed by ultrasound when clinically indicated.
|
1 year postoperatively
|
協力者と研究者
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
その他の研究ID番号
- CAPPUCCINOH
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
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。