Clinical Trial: Laparoscopic Management of Periappendicular Abscess

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial

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 Summary:
Sponsor: Helsinki University Central Hospital

Current Primary Outcome: Time of hospitalization within the first 60 days after randomization [ Time Frame: Day 60 after randomization ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need of additional interventions [ Time Frame: Within the first 60 days after randomization ]
    Interventions include percutaneous drainage and operations
  • Residual abscess [ Time Frame: On day 7 after randomization ]
  • Attempted procedure not successfully performed [ Time Frame: 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 [ Time Frame: Within 60 days from randomization ]
    Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.
  • Number recurrent abscesses [ Time Frame: Within 60 days after randomization ]


Original Secondary Outcome: Same as current

Information By: Helsinki University Central Hospital

Dates:
Date Received: January 20, 2011
Date Started: January 2011
Date Completion:
Last Updated: September 21, 2014
Last Verified: September 2014