Laparoscopic Management of Periappendicular Abscess
Primary Purpose
Appendicitis, Abdominal Abscess
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Laparoscopic appendectomy
Conservative management with percutaneous drainage
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring Laparoscopy, Drainage, Appendectomy
Eligibility Criteria
Inclusion Criteria:
- Periappendicular abscess at least 2 cm in size
Exclusion Criteria:
- Missing written informed consent
- 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
Sites / Locations
- Helsinki University Central Hospital, Meilahti Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conservative management
Laparoscopic appendectomy
Arm Description
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 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
Outcomes
Primary Outcome Measures
Time of hospitalization within the first 60 days after randomization
Secondary Outcome Measures
Need of additional interventions
Interventions include percutaneous drainage and operations
Residual abscess
Attempted procedure not successfully performed
In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible.
The number of complications
Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.
Number recurrent abscesses
Full Information
NCT ID
NCT01283815
First Posted
January 20, 2011
Last Updated
September 21, 2014
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01283815
Brief Title
Laparoscopic Management of Periappendicular Abscess
Official Title
Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Abdominal Abscess
Keywords
Laparoscopy, Drainage, Appendectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative management
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Laparoscopic appendectomy
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Conservative management with percutaneous drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time of hospitalization within the first 60 days after randomization
Time Frame
Day 60 after randomization
Secondary Outcome Measure Information:
Title
Need of additional interventions
Description
Interventions include percutaneous drainage and operations
Time Frame
Within the first 60 days after randomization
Title
Residual abscess
Time Frame
On day 7 after randomization
Title
Attempted procedure not successfully performed
Description
In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible.
Time Frame
During the first 24 hours after randomization
Title
The number of complications
Description
Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.
Time Frame
Within 60 days from randomization
Title
Number recurrent abscesses
Time Frame
Within 60 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Periappendicular abscess at least 2 cm in size
Exclusion Criteria:
Missing written informed consent
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panu Mentula, M.D. Ph.D.
Organizational Affiliation
Department of Gastrointestinal Surgery, Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital, Meilahti Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Management of Periappendicular Abscess
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