Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Acute Appendicitis Clinical Trial

— APPAC  

Official title:

Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01022567
• Other study ID #: APPAC
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2009
• Est. completion date: December 2025

Study information

• Verified date: May 2018
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 530
• Est. completion date: December 2025
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

Intervention

Procedure:
• Appendicectomy
Standard appendicectomy

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.

Locations

Country	Name	City	State
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

Sponsors (6)

Lead Sponsor	Collaborator
Turku University Hospital	Jyväskylä Central Hospital, Mikkeli Central Hospital, Oulu University Hospital, Seinajoki Central Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Paajanen H, Grönroos JM, Rautio T, Nordström P, Aarnio M, Rantanen T, Hurme S, Dean K, Jartti A, Mecklin JP, Sand J, Salminen P. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial). BMC Surg. 2013 Feb 8;13:3. doi: 10.1186/1471-2482-13-3. — View Citation

Salminen P, Paajanen H, Rautio T, Nordström P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Grönroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPA — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis	A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.	Up to 10 years
Secondary	The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment		1 year
Secondary	The Direct and Indirect Costs of Both Treatment Arms		1 year
Secondary	The Recurrence of Conservatively Treated Appendicitis		up to 10 years

External Links

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