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Fast-track Giant Ventral Hernia Repair

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Bispebjerg Hospital

关键词

抽象

The implementation of an enhanced recovery pathway after giant ventral hernia repair, including preoperative high-dose steroid is examined prospectively and compared with a group of historic controls.

描述

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.

日期

最后验证: 08/31/2015
首次提交: 11/10/2014
提交的预估入学人数: 11/26/2014
首次发布: 12/01/2014
上次提交的更新: 09/02/2015
最近更新发布: 09/06/2015
实际学习开始日期: 11/30/2014
预计主要完成日期: 06/30/2015
预计完成日期: 06/30/2015

状况或疾病

Hernia, Ventral

干预/治疗

Other: Fast-track group

-

手臂组

干预/治疗
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.

资格标准

有资格学习的性别All
取样方式Non-Probability Sample
接受健康志愿者
标准

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

结果

主要结果指标

1. Time to discharge [Participants will be followed for the duration of hospital stay, an expected average of 72 hours]

Time from surgery to discharge [Hours].

次要成果指标

1. Fatigue [Preoperative and for the duration of hospital stay, an expected average of 3 days]

Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No fatigue, 5 = Exhausted).

2. Pain from supine to standing [Preoperative and for the duration of hospital stay, an expected average of 3 days]

Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain)

3. Pain when walking 6 meters [Preoperative and for the duration of hospital stay, an expected average of 3 days]

Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain)

4. Nausea [Preoperative and for the duration of hospital stay, an expected average of 3 days]

Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No nausea, 5 = Intolerable nausea)

5. Time to bowel function [For the duration of postoperative hospital stay, an expected average of 72 hours]

The time to bowel function [hours] will be registered for each participant

6. Vomiting episodes [Participants will be followed for the duration of hospital stay, an expected average of 3 days]

The daily number of vomiting episodes will be registered for each participant

7. Continuous transcutaneous saturation [From surgery to postoperative day 3 at 12 pm]

Continuous transcutaneous oxygen saturation (percentage), measured by Pulsox 300i (C) (Konica Minolta, Osaka, Japan)

8. C-reactive protein from venous blood sample [Preoperative and for the duration of hospital stay, an expected average of 3 days]

Daily C-reactive protein measured in a venous blood sample.

9. Ear temperature [Preoperative and for the duration of hospital stay, an expected average of 3 days]

Ear temperature (celsius degree) measured daily at 9 and 15.

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]

The reason(s) for participants not being discharged if discharge criteria are otherwise fulfilled.

11. Daily wound drain production [From surgery and for the duration of hospital stay, an expected average of 3 days]

Daily registration of the fluid volume [milliliters] in the wound drains postoperative.

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