- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777034
Laparoscopy Combined With Enhanced Recovery Pathway
Short-Term Outcomes of Laparoscopy Combined With Enhanced Recovery Pathway After Ileocolon Resection for Crohn's Disease
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jianjian Xiang, doctor
- Phone Number: 008613588706479
- Email: nuzwlvran@163.com
Study Contact Backup
- Name: Xiang
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Sir Run Run Shaw Hospital
-
Contact:
- Jianjian Xiang, doctor
- Phone Number: 008615168326849
- Email: ybxjj1990@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Recovery
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). |
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 Names:
|
Other: Unenhanced Recovery
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). |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time of Flatus and Defecation
Time Frame: 0-10 days
|
0-10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time of liquid diet and semiliquid diet
Time Frame: 0-10 days
|
0-10 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative complications
Time Frame: 0-10 days
|
0-10 days
|
Postoperative hospitalization cost
Time Frame: 0-10 days
|
0-10 days
|
Hospital readmission rates
Time Frame: 0-30 days after discharge
|
0-30 days after discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Wei Zhou, Doctor, Sir Run Run Shaw Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRRSH20160427-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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