Laparoscopic Management of Periappendicular Abscess

Overview

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.

Full Title of Study: “Laparoscopic Management of Periappendicular Abscess – Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Interventions

  • 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).
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Time of hospitalization within the first 60 days after randomization
    • Time Frame: Day 60 after randomization

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Panu Mentula, Surgeon – Helsinki University Central Hospital
  • Overall Official(s)
    • Panu Mentula, M.D. Ph.D., Principal Investigator, Department of Gastrointestinal Surgery, Helsinki University Central Hospital

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