Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (APPAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Turku University Hospital
Sponsor:
Information provided by:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01022567
First received: November 30, 2009
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a "routine" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis.

The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.


Condition Intervention
Acute Appendicitis
Procedure: Appendicectomy
Drug: Ertapenem

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • The success of antibiotic and surgical treatment in the treatment of acute uncomplicated appendicitis [ Time Frame: 1.-3. days, 1 week, 2 months, 1 year, 3,5,10 y ] [ Designated as safety issue: No ]
    A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.


Secondary Outcome Measures:
  • The possible complications, morbidity and mortality of operative and conservative treatment [ Time Frame: Same as primary outcome measure ] [ Designated as safety issue: No ]
  • The direct and indirect costs of both treatment arms [ Time Frame: Same as primary outcome measure ] [ Designated as safety issue: No ]
  • The recurrence of conservatively treated appendicitis [ Time Frame: Same as primary outcome measure ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: November 2009
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Operative treatment
Regular open appendicectomy
Procedure: Appendicectomy
Standard appendicectomy
Active Comparator: Antibiotic treatment
Ertapenem 1 g i.v. x 1 three days
Drug: Ertapenem
ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age range from 18 to 60 years
  • CT scan diagnosed uncomplicated acute appendicitis

Exclusion Criteria:

  • Age under 18 years or age over 60 years
  • Pregnancy or breast-feeding
  • Allergy to contrast media or iodine
  • Renal insufficiency
  • metformin medication (DM)
  • Peritonitis (a perforated appendix)
  • Lack of co-operation (unable to give consent)
  • A severe other medical condition
  • CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour
  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: NCT01022567

Contacts
Contact: Paulina Salminen, MD, PhD +358 2 313 0542 paulina.salminen@tyks.fi
Contact: Juha Grönroos, MD, PhD +358 2 313 0247 juha.gronroos@tyks.fi

Locations
Finland
Pohjois-Karjala Central Hospital Recruiting
Joensuu, Finland
Principal Investigator: Heikki Ahtola, MD, PhD         
Sub-Investigator: Heini Savolainen, MD, PhD         
Keski-Suomi Central Hosptal Recruiting
Jyväskylä, Finland
Sub-Investigator: Jukka-Pekka Mecklin, MD, PhD         
Principal Investigator: Markku Aarnio, MD, PhD         
Mikkeli Central Hospital Recruiting
Mikkeli, Finland
Principal Investigator: Hannu Paajanen, MD, PhD         
Oulu University Hospital Recruiting
Oulu, Finland
Principal Investigator: Tero Rautio, MD, PhD         
Sub-Investigator: Airi Jartti, MD, PhD         
Seinäjoki Central Hospital Recruiting
Seinäjoki, Finland
Contact: Tuomo Rantanen, MD, PhD         
Principal Investigator: Tuomo Rantanen, MD, PhD         
Tampere University Hospital Recruiting
Tampere, Finland
Principal Investigator: Pia Nordström, MD, PhD         
Sub-Investigator: Juhani Sand, MD, PhD         
Turku University Hospital Recruiting
Turku, Finland
Contact: Paulina Salminen       paulina.salminen@tyks.fi   
Principal Investigator: Paulina Salminen, MD, PhD         
Sub-Investigator: Juha Grönroos, MD, PhD         
Sub-Investigator: Kirsti Dean, MD         
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Paulina Salminen, MD, PhD Department of surgery, Turku University Hospital
  More Information

No publications provided by Turku University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paulina Salminen, Paulina Salminen, Turku University Hospital, Department of Surgery
ClinicalTrials.gov Identifier: NCT01022567     History of Changes
Other Study ID Numbers: APPAC
Study First Received: November 30, 2009
Last Updated: May 16, 2011
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Ertapenem
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 16, 2014