Laparoscopic Management of Periappendicular Abscess

Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis; Abdominal Abscess
• Intervention / Treatment: Procedure: Conservative management with percutaneous drainage; Procedure: Laparoscopic appendectomy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital, Meilahti Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of hospitalization within the first 60 days after randomization	Day 60 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of additional interventions	Interventions include percutaneous drainage and operations	Within the first 60 days after randomization
Residual abscess		On day 7 after randomization
Attempted procedure not successfully performed	In the laparoscopy group appendectomy was not possible. In the conservative group planned percutaneous drainage was not possible.	During the first 24 hours after randomization
The number of complications	Any complication occurring within 60 days from randomization. Both medical and surgical complications are included.	Within 60 days from randomization
Number recurrent abscesses		Within 60 days after randomization

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Panu Mentula, M.D. Ph.D., Department of Gastrointestinal Surgery, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 20, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): September 23, 2014
• Last Update Submitted That Met QC Criteria: September 21, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Drainage; Laparoscopy; Appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Inflammation; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Suppuration; Cecal Diseases; Intraabdominal Infections; Abscess; Appendicitis; Abdominal Abscess
• Other Study ID Numbers: HUSOper193