We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01022567
First Posted: December 1, 2009
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oulu University Hospital
Tampere University Hospital
Mikkeli Central Hospital
Jyväskylä Central Hospital
Seinajoki Central Hospital
Information provided by (Responsible Party):
Paulina Salminen, Turku University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Paulina Salminen, Turku University Hospital:

Primary Outcome Measures:
  • The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis [ Time Frame: Up to 10 years ]
    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: 1 year ]
  • The Direct and Indirect Costs of Both Treatment Arms [ Time Frame: 1 year ]
  • The Recurrence of Conservatively Treated Appendicitis [ Time Frame: up to 10 years ]

Enrollment: 530
Study Start Date: November 2009
Estimated Study Completion Date: December 2025
Primary Completion Date: June 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022567


Locations
Finland
Keski-Suomi Central Hosptal
Jyväskylä, Finland
Mikkeli Central Hospital
Mikkeli, Finland
Oulu University Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
Oulu University Hospital
Tampere University Hospital
Mikkeli Central Hospital
Jyväskylä Central Hospital
Seinajoki Central Hospital
Investigators
Principal Investigator: Paulina Salminen, MD, PhD Department of surgery, Turku University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Paulina Salminen, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01022567     History of Changes
Other Study ID Numbers: APPAC
First Submitted: November 30, 2009
First Posted: December 1, 2009
Results First Submitted: August 21, 2016
Results First Posted: February 23, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Ertapenem
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents


To Top