Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors
Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors in Patients Scheduled for Laparotomy: A Pilot Study
Patients included in the study went through standard preoperative preparation and were informed about potential conversion to open surgery. The procedure started with LUS performed according to the department's standard guidelines (one twelve mm trocar in the midline and one 12 mm trocar in the left upper quadrant) followed by a stepwise scanning of relevant structures (e.g. liver, pancreas, retroperitoneum) with dedicated laparoscopic ultrasound equipment (BK Medical, Herlev, Denmark). If the suspected lesion(s) was detected by LUS in the relevant area (according to preoperative imaging), laparoscopic resection was attempted, and if successful the specimen was removed in an eEndo-bBag (Kebomed, Denmark) through one of the trocars. A second LUS was performed to ensure that no tumor was left behind ("loss-of-lesion(s)").
If any problem occurred during the laparoscopic procedure, the operation was converted to an open procedure. Prophylactic antibiotics were not given routinely but were administered during surgery at the surgeons' discretion.
The intra- and postoperative course and final clinical outcome including pathology reports were retrieved from the patient's electronical records. This included a postoperative follow up of at least 12 months to investigate potential incomplete resection. Postoperative complications were graded according to Dindo-Clavien (17). The pathology reports were retrieved from the Danish Pathology Registry.
調査の概要
状態
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Odense C、デンマーク、5000
- 募集
- Odense University Hospital
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コンタクト:
- Michael B Mortensen, MD, PhD
- 電話番号:45 6541 1857
- メール:michael.bau.mortensen@rsyd.dk
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
Patients with intra- and retroperitoneal tumor(s) (IRT) detected by imaging (US/CTMR/PET or EUS) and a clinical indication for explorative laparotomy
Exclusion Criteria:
Patients with contraindications for laparoscopy, such as severe adherences were excluded
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
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 |
|---|---|---|
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Tumor localization
時間枠:12 months
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Positive LUS localization of the tumor(s) in minimum 15 patients
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12 months
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LUS guided resection
時間枠:12 months
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A complete LUS guided resection in minimum 15 patients
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12 months
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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 |
|---|---|---|
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Complications
時間枠:12 months
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No clinical important complications (Dindo-Clavien ≥3) in any of the patients where LUS guided resection was performed and completed
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12 months
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Final diagnosis
時間枠:12 months
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A pathological diagnosis was obtained based on the resected tumor(s) in all cases.
The LUS guided procedure should obviate the need for (subsequent) open surgery in all patients
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12 months
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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 (予想される)
研究の完了 (予想される)
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
- MBM-41
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?
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