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
PHASE2
60 participants
INTERVENTIONAL
2011-01-31
2014-08-31
Brief Summary
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The hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conservative management
Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed.
Conservative management with percutaneous drainage
Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed.
Laparoscopic appendectomy
Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group
Laparoscopic appendectomy
Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day).
Interventions
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Laparoscopic appendectomy
Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day).
Conservative management with percutaneous drainage
Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Antimicrobial therapy lasted over 24 hours before randomization
* Attempt of drainage before randomization
* Age over 80 years or under 18 years old
* Pregnancy
* Allergy to either Cefuroxime or Metronidazole
* Severe chronic disease, that substantially increases the risk for operative mortality
* Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions
* Carrier of a resistant bacterial strain
* Being institutionalized or hospitalized for at least 2 weeks before randomization
18 Years
80 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Panu Mentula
Surgeon
Principal Investigators
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Panu Mentula, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Gastrointestinal Surgery, Helsinki University Central Hospital
Locations
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Helsinki University Central Hospital, Meilahti Hospital
Helsinki, , Finland
Countries
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Other Identifiers
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HUSOper193
Identifier Type: -
Identifier Source: org_study_id
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