Laparoscopy Combined With Enhanced Recovery Pathway

Zhejiang University

Status: Unknown

Conditions: Crohn's Disease

Treatments: Other: ER; Other: UR

Study type: Interventional

Funder types: Other

Identifiers

NCT02777034

SRRSH20160427-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Enhanced Recovery

Experimental group

Description:

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）.

Treatment:

Other: ER

Unenhanced Recovery

Other group

Description:

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）.

Treatment:

Other: UR