Fast-track Giant Ventral Hernia Repair
キーワード
概要
説明
All patients operated on for a large incisional hernia are treated according to the study protocol. Patients are given high-dose glucocorticoid preoperative and the aim is to discharge patients at postoperative day 3.
Morbidity, length of stay, pain, nausea and pulmonary function are among registered outcomes compared with a historic control group.
日付
| 最終確認済み: | 08/31/2015 |
| 最初に提出された: | 11/10/2014 |
| 提出された推定登録数: | 11/26/2014 |
| 最初の投稿: | 12/01/2014 |
| 最終更新が送信されました: | 09/02/2015 |
| 最終更新日: | 09/06/2015 |
| 実際の研究開始日: | 11/30/2014 |
| 一次完了予定日: | 06/30/2015 |
| 研究完了予定日: | 06/30/2015 |
状態または病気
介入/治療
Other: Fast-track group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Fast-track group Patients treated according to the enhanced recovery pathway. This group is examined prospectively. | Other: Fast-track group Enhanced recovery after surgery pathway. Postoperatively, a set of well-defined discharge criteria will be assessed daily at 9:00 and 15:00, as well as pain, nausea, time to flatus, saturation and drain production. |
| Control group Patients treated according to the historic recovery pathway. This group is examined retrospectively. |
適格基準
| 研究に適格な性別 | All |
| サンプリング方法 | Non-Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Horizontal fascia defect > 10 cm on computed tomography scan - Planned elective open incisional hernia repair Exclusion Criteria: - Known allergy against glucocorticoid treatment - Insulin-treated diabetes - Gastric ulcer diagnosed within four weeks preoperative - Steroid-treated immune disease - Planned intestinal anastomosis concomitant to hernia repair |
結果
主な結果の測定
1. Time to discharge [Participants will be followed for the duration of hospital stay, an expected average of 72 hours]
二次的な結果の測定
1. Fatigue [Preoperative and for the duration of hospital stay, an expected average of 3 days]
2. Pain from supine to standing [Preoperative and for the duration of hospital stay, an expected average of 3 days]
3. Pain when walking 6 meters [Preoperative and for the duration of hospital stay, an expected average of 3 days]
4. Nausea [Preoperative and for the duration of hospital stay, an expected average of 3 days]
5. Time to bowel function [For the duration of postoperative hospital stay, an expected average of 72 hours]
6. Vomiting episodes [Participants will be followed for the duration of hospital stay, an expected average of 3 days]
7. Continuous transcutaneous saturation [From surgery to postoperative day 3 at 12 pm]
8. C-reactive protein from venous blood sample [Preoperative and for the duration of hospital stay, an expected average of 3 days]
9. Ear temperature [Preoperative and for the duration of hospital stay, an expected average of 3 days]
10. Detailed reason for not being discharged if criteria are otherwise fulfilled [From surgery and for the duration of hospital stay, an expected average of 3 days]
11. Daily wound drain production [From surgery and for the duration of hospital stay, an expected average of 3 days]
