Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Not Applicable

Active, not recruiting

• Conditions: Acute Appendicitis
• Interventions: Procedure: Appendicectomy; Drug: Ertapenem

• Registration Number: NCT01022567
• Lead Sponsor: Turku University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2012-06
• Results First Submitted: 2016-08-21
• Results First Submitted QC: 2017-01-02
• Results First Posted: 2017-02-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-06-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 530

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative treatment	Appendicectomy	Regular open appendicectomy
Antibiotic treatment	Ertapenem	Ertapenem 1 g i.v. x 1 three days

Primary Outcome Measures

Name	Time	Method
The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis	Up to 10 years	A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.

Secondary Outcome Measures

Name	Time	Method
The Direct and Indirect Costs of Both Treatment Arms	1 year
The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment	1 year
The Recurrence of Conservatively Treated Appendicitis	up to 10 years

Trial Locations

Locations (6)

Turku University Hospital; 🇫🇮 Turku, Finland

Keski-Suomi Central Hosptal; 🇫🇮 Jyväskylä, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Mikkeli Central Hospital; 🇫🇮 Mikkeli, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland