Laparoscopic Management of Periappendicular Abscess

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 2

Conditions: Appendicitis; Abdominal Abscess

Treatments: Procedure: Conservative management with percutaneous drainage; Procedure: Laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01283815

HUSOper193

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Conservative management

Active Comparator group

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.

Treatment:

Procedure: Conservative management with percutaneous drainage

Laparoscopic appendectomy

Experimental group

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

Treatment:

Procedure: Laparoscopic appendectomy