Laparoscopic Management of Periappendicular Abscess

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01283815

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis Abdominal Abscess	Procedure: Laparoscopic appendectomy Procedure: Conservative management with percutaneous drainage	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conservative management 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 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.
Experimental: 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	Procedure: 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 (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day).

Arm

Intervention/Treatment

Active Comparator: Conservative management

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

Experimental: 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

Procedure: Laparoscopic appendectomy

Outcome Measures

Primary Outcome Measures

Time of hospitalization within the first 60 days after randomization [Day 60 after randomization]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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