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Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease.
Thirty patients with CD of ileocolon will be randomly assigned to two groups.One group is ERP group which include no bowel preparation nor fasting, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization and restrictive fluid management.In the end,we can compare the time to first flatus、time to first flatus 、postoperative length of stay postoperative hospital expense、complication grade readmission within 30 days of discharge between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Recovery | Experimental | Preoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）. Intraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains. Postoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（<2000ml/d）. |
|
| Unenhanced Recovery | Other | Preoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation. Intraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains. Postoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（>2000ml/d）. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ER | Other | Preoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）. Intraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains. Postoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（<2000ml/d）. |
| Measure | Description | Time Frame |
|---|---|---|
| The time of Flatus and Defecation | 0-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| The time of liquid diet and semiliquid diet | 0-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | 0-10 days | |
| Postoperative hospitalization cost | 0-10 days | |
| Hospital readmission rates |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianjian Xiang, doctor | Contact | 008613588706479 | nuzwlvran@163.com | |
| Xiang | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhou, Doctor | Sir Run Run Shaw Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22948838 | Result | Spinelli A, Bazzi P, Sacchi M, Danese S, Fiorino G, Malesci A, Gentilini L, Poggioli G, Montorsi M. Short-term outcomes of laparoscopy combined with enhanced recovery pathway after ileocecal resection for Crohn's disease: a case-matched analysis. J Gastrointest Surg. 2013 Jan;17(1):126-32; discussion p.132. doi: 10.1007/s11605-012-2012-5. Epub 2012 Sep 5. | |
| 15932565 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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| UR | Other | Preoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation. Intraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains. Postoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（>2000ml/d）. |
|
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| 0-30 days after discharge |
| Andersen J, Kehlet H. Fast track open ileo-colic resections for Crohn's disease. Colorectal Dis. 2005 Jul;7(4):394-7. doi: 10.1111/j.1463-1318.2005.00788.x. |
| 22241289 | Result | Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2. |
| 30534152 | Derived | Zhu Y, Xiang J, Liu W, Cao Q, Zhou W. Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study. Gastroenterol Res Pract. 2018 Nov 11;2018:9648674. doi: 10.1155/2018/9648674. eCollection 2018. |
| D007410 | Intestinal Diseases |