Laparoscopy Combined With Enhanced Recovery Pathway

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02777034
• Other study ID #: SRRSH20160427-001
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2016
• Last updated: May 18, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Sir Run Run Shaw Hospital
• Contact: Jianjian Xiang, doctor
• Phone: 008613588706479
• Email: nuzwlvran[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Zhejiang Province
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• 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).
• 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).

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Andersen J, Kehlet H. Fast track open ileo-colic resections for Crohn's disease. Colorectal Dis. 2005 Jul;7(4):394-7. — View Citation

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 Gastro — View Citation

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 perioperativ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative complications		0-10 days	Yes
Other	Postoperative hospitalization cost		0-10 days	Yes
Other	Hospital readmission rates		0-30 days after discharge	Yes
Primary	The time of Flatus and Defecation		0-10 days	Yes
Secondary	The time of liquid diet and semiliquid diet		0-10 days	Yes