Abdominal Abscess, Appendicitis
Conditions
Keywords
Laparoscopy, Drainage, Appendectomy
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.
Interventions
PROCEDURELaparoscopic 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).
PROCEDUREConservative 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.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of hospitalization within the first 60 days after randomization | Day 60 after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of additional interventions | Within the first 60 days after randomization | Interventions include percutaneous drainage and operations |
| Residual abscess | On day 7 after randomization | — |
| Attempted procedure not successfully performed | During the first 24 hours after randomization | In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible. |
| The number of complications | Within 60 days from randomization | Any complication occurring within 60 days from randomization. Both medical and surgical complications are included. |
| Number recurrent abscesses | Within 60 days after randomization | — |
Countries
Finland
Outcome results
None listed