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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27190
Enrollment
60
Registered
2009-01-14
Start date
2000-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Crohn's disease - ziekte van Crohn steroid refractory - steroid refractair ileocolic resection - ileocecaal resectie laparoscopic-assisted - laparoscopisch-geassisteerd open approach - open benadering

Interventions

A laparoscopic-assisted or an open ileocolic resection.

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Crohn's disease scheduled for an elective ileocolic resection; 2. age above 16 years.

Exclusion criteria

Exclusion criteria: 1. Fixed palpable inflammatory mass prior to surgery; 2. prior median laparotomy; 3. earlier bowel resection; 4. pregnancy.

Design outcomes

Primary

MeasureTime frame
Short term: 1. postoperative quality of life. Long term primary outcomes: 1. intestinal disease recurrence; 2. no. of reoperations for incisional hernia; 3. no. of reoperations for adhesive small bowel obstruction.

Secondary

MeasureTime frame
Short term: 1. operating time; 2. blood loss; 3. conversion rate; 4. early morbidity; 5. morphine requirement; 6. pain VAS scores; 7. mortality; 8. hospital stay; 9. costs. Long term outcomes: 1. QOL; 2. body image and cosmesis.

Contacts

Public ContactW.A. Bemelman

Academic Medical Center (AMC), Department of Surgery P.O. Box 22660

W.A.Bemelman@amc.uva.nl+31 (0)6 30023579

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)