Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Condition(s) targeted: Acute Appendicitis

Intervention: Appendicectomy (Procedure); Ertapenem (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Turku University Hospital

Official(s) and/or principal investigator(s):
Paulina Salminen, MD, PhD, Principal Investigator, Affiliation: Department of surgery, Turku University Hospital

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The success of antibiotic and surgical treatment in the treatment of acute uncomplicated appendicitis

Secondary outcome:

The possible complications, morbidity and mortality of operative and conservative treatment

The direct and indirect costs of both treatment arms

The recurrence of conservatively treated appendicitis

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

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

Related publications:

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.

Starting date: November 2009
Last updated: August 18, 2015