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Laparoscopy Combined With Enhanced Recovery Pathway

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02777034
Enrollment
30
Registered
2016-05-19
Start date
2016-05-31
Completion date
2017-12-31
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Laparoscopy, Enhanced Recovery, Fast-track

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.

Interventions

OTHERER

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).

OTHERUR

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).

Sponsors

Sir Run Run Shaw Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The time of Flatus and Defecation0-10 days

Secondary

MeasureTime frame
The time of liquid diet and semiliquid diet0-10 days

Other

MeasureTime frame
Postoperative complications0-10 days
Postoperative hospitalization cost0-10 days
Hospital readmission rates0-30 days after discharge

Countries

China

Contacts

Primary ContactJianjian Xiang, doctor
nuzwlvran@163.com008613588706479
Backup ContactXiang

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026