Laparoscopy Combined With Enhanced Recovery Pathway

Not Applicable

• Conditions: Crohn's Disease
• Interventions: Other: UR; Other: ER

• Registration Number: NCT02777034
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

Laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for Crohn's Disease.

Detailed Description

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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-05
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-18
• Last Update Submitted: 2016-05-18
• Study First Posted: 2016-05-19
• Last Update Posted: 2016-05-19
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unenhanced Recovery	UR	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）.
Enhanced Recovery	ER	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）.

Primary Outcome Measures

Name	Time	Method
The time of Flatus and Defecation	0-10 days

Secondary Outcome Measures

Name	Time	Method
The time of liquid diet and semiliquid diet	0-10 days

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China