Laparoscopy Combined With Enhanced Recovery Pathway

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Short-Term Outcomes of Laparoscopy Combined With Enhanced Recovery Pathway After Ileocolon Resection for Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: ER
* Other: UR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18 years≤aged≤75 years) were included if they had histologically or radiographic proven CD with disease localized to the terminal ileum with or without ascending colon involvement. Exclusion Criteria: Those patients were excluded：previous bowel resection or strictureplasty, preoperative radiological evidence of large phlegmons/abscesses/enteric fistulas (assessed by magnetic resonance imaging or computed tomography), emergency surgery, and anesthesiological contraindications to laparoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Recovery<br>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）. | Other: ER<br>* 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）.<br>* Other names: Enhanced Recovery;|
| Other: Unenhanced Recovery<br>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）. | Other: UR<br>* 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）.<br>* Other names: Un-Enhanced Recovery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of Flatus and Defecation |  | 0-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of liquid diet and semiliquid diet |  | 0-10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Enhanced Recovery, Fast-track