Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy
NCT ID: NCT01740973
Last Updated: 2015-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
699 participants
OBSERVATIONAL
2014-04-30
2014-09-30
Brief Summary
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This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC vs. conventional 4-port laparoscopic cholesystectomy.
Methods This is a cohort registry study with prospective questionnaire and clinical follow-up on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a conventional laparoscopic cholecystectomy (consecutively from one month before and after SILC. They are matched for age, gender, date of operation, and surgeons skills (database from intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation (operation for a umbilical hernia or clinical hernia).
The H0 hypothesis is that there is not difference between SILC and conventional.
Exclusion criteria are: death, operation for acute cholecystitis. The included patients will be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia, and perioperative data that we do not have in the database. Futhermore those patients who suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis. Furthermore we patients are asked to report if they have chronic pain and/or discomfort.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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SILC cholecystectomy
No intervention. 239 SILC having a prospective questionnaire and clinical follow-up, if the patient suspects an umbilical hernia.
No interventions assigned to this group
and conventional lap. cholecystectomy
no intervention.Patients are also mailed a prospective questionnaire and clinical follow-up, if the patient suspects an umbilical hernia.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* an abdominal operation before la.chol/SILC with midline incision
* an abdominal operation after la.chol/SILC with midline incision
* primary operation for acute cholecystitis
18 Years
90 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Mette Willaume Christoffersen
M. D.
Principal Investigators
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Mette w Christoffersen
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Locations
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Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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UMBI-SILS-123
Identifier Type: -
Identifier Source: org_study_id
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