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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative management | Active Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic appendectomy | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Time of hospitalization within the first 60 days after randomization | Day 60 after randomization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panu Mentula, M.D. Ph.D. | Department of Gastrointestinal Surgery, Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital, Meilahti Hospital | Helsinki | 00029 | Finland |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D018784 | Abdominal Abscess |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Conservative management with percutaneous drainage | Procedure | 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. |
|
| 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 |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D000038 | Abscess |
| D013492 | Suppuration |