Crohn Disease of Ileum Clinical Trial
Official title:
Minimally Invasive Open Technique for Ileo-colic Resection in Complex Cases of Terminal Ileum Crohn's Disease. Case Series.
Verified date | May 2019 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.
Status | Completed |
Enrollment | 27 |
Est. completion date | May 4, 2019 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - diagnosed Crohn's disease - previous appendectomy trough a mcburney incision Exclusion Criteria: - patients with major comorbidities - age>75 - previous midline laparotomy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean operative time | duration of surgical procedure | 75-156 minutes | |
Primary | Mean blood loss during surgical procedure | blood loss from the beginning to the end of the procedure | 2 hours | |
Primary | Mean post-operative hospital stay | time from day of surgery to discharge | 3-7 days | |
Secondary | post-operative complications | complications according to Clavien Dindo classification | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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