Laparoscopic Management of Periappendicular Abscess

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Panu Mentula, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01283815
First received: January 20, 2011
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Appendicitis
Abdominal Abscess
Procedure: Laparoscopic appendectomy
Procedure: Conservative management with percutaneous drainage
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Time of hospitalization within the first 60 days after randomization [ Time Frame: Day 60 after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need of additional interventions [ Time Frame: Within the first 60 days after randomization ] [ Designated as safety issue: Yes ]
    Interventions include percutaneous drainage and operations

  • Residual abscess [ Time Frame: On day 7 after randomization ] [ Designated as safety issue: No ]
  • Attempted procedure not successfully performed [ Time Frame: During the first 24 hours after randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283815

Contacts
Contact: Panu Mentula, M.D., Ph.D. +358504270183 panu.mentula@hus.fi

Locations
Finland
Helsinki University Central Hospital, Meilahti Hospital Recruiting
Helsinki, Finland, 00029
Contact: Panu Mentula       panu.mentula@hus.fi   
Principal Investigator: Panu Mentula, M.D. Ph.D.         
Sub-Investigator: Ari Leppäniemi, M.D. Ph.D.         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Panu Mentula, M.D. Ph.D. Department of Gastrointestinal Surgery, Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Panu Mentula, Surgeon, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01283815     History of Changes
Other Study ID Numbers: HUSOper193
Study First Received: January 20, 2011
Last Updated: May 22, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
Laparoscopy
Drainage
Appendectomy

Additional relevant MeSH terms:
Abscess
Appendicitis
Abdominal Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Intraabdominal Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 14, 2014