Laparoscopic Management of Periappendicular Abscess

Phase 2

Completed

• Conditions: Appendicitis; Abdominal Abscess
• Interventions: Procedure: Conservative management with percutaneous drainage; Procedure: Laparoscopic appendectomy

• Registration Number: NCT01283815
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-21
• Last Update Posted: 2014-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative management	Conservative 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.
Laparoscopic appendectomy	Laparoscopic 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

Primary Outcome Measures

Name	Time	Method
Time of hospitalization within the first 60 days after randomization	Day 60 after randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Helsinki University Central Hospital, Meilahti Hospital; 🇫🇮 Helsinki, Finland