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aparoscopic-assisted versus open ileocolic resection for Crohn's disease.

Completed
Conditions
Crohn's disease - ziekte van Crohnsteroid refractory - steroid refractairileocolic resection - ileocecaal resectielaparoscopic-assisted - laparoscopisch-geassisteerdopen approach - open benadering
Registration Number
NL-OMON27190
Lead Sponsor
Academic Medical Center
Brief Summary

laparoscopic-assisted versus open ileocolic resection for Crohn's disease - a randomized trial (ann surg feb;243(2):143-9; discussion 150-3).

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

1. Patients with Crohn's disease scheduled for an elective ileocolic resection;

2. age above 16 years.

Exclusion Criteria

1. Fixed palpable inflammatory mass prior to surgery;

2. prior median laparotomy;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Short term:<br /><br>1. postoperative quality of life.<br><br /><br /><br>Long term primary outcomes:<br /><br>1. intestinal disease recurrence;<br /><br>2. no. of reoperations for incisional hernia;<br /><br>3. no. of reoperations for adhesive small <br>bowel obstruction.
Secondary Outcome Measures
NameTimeMethod
Short term:<br /><br>1. operating time;<br /><br>2. blood loss;<br /><br>3. conversion rate;<br /><br>4. early morbidity;<br /><br>5. morphine requirement;<br /><br>6. pain VAS scores;<br /><br>7. mortality;<br /><br>8. hospital stay;<br /><br>9. costs.<br /><br><br /><br /><br>Long term outcomes:<br /><br>1. QOL;<br /><br>2. body image and cosmesis.
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