Laparoscopic Management of Periappendicular Abscess

Study Overview
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Brief Summary
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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.

Official Title
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Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial

Conditions
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Appendicitis, Abdominal Abscess

Intervention / Treatment
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* Procedure: Laparoscopic appendectomy
* Procedure: Conservative management with percutaneous drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative management<br>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. | Procedure: Conservative management with percutaneous drainage<br>* 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.<br>|
| Experimental: Laparoscopic appendectomy<br>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 | Procedure: Laparoscopic appendectomy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of hospitalization within the first 60 days after randomization |  | Day 60 after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of additional interventions | Interventions include percutaneous drainage and operations | Within the first 60 days after randomization | 
| Residual abscess |  | On day 7 after randomization | 
| Attempted procedure not successfully performed | In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible. | During the first 24 hours after randomization | 
| The number of complications | Any complication occurring within 60 days from randomization. Both medical and surgical complications are included. | Within 60 days from randomization | 
| Number recurrent abscesses |  | Within 60 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Drainage, Appendectomy