Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis (APPAC)
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| ClinicalTrials.gov Identifier: NCT01022567 |
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Recruitment Status :
Active, not recruiting
First Posted : December 1, 2009
Results First Posted : February 23, 2017
Last Update Posted : June 28, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Appendicitis | Procedure: Appendicectomy Drug: Ertapenem | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 530 participants |
| 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 |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | June 2012 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Operative treatment
Regular open appendicectomy
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Procedure: Appendicectomy
Standard appendicectomy |
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Active Comparator: Antibiotic treatment
Ertapenem 1 g i.v. x 1 three days
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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. |
- 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.
- 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 ]
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| 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 | |
| Principal Investigator: | Paulina Salminen, MD, PhD | Department of surgery, Turku University Hospital |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Paulina Salminen, MD, PhD, Turku University Hospital |
| ClinicalTrials.gov Identifier: | NCT01022567 |
| Other Study ID Numbers: |
APPAC |
| First Posted: | December 1, 2009 Key Record Dates |
| Results First Posted: | February 23, 2017 |
| Last Update Posted: | June 28, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Appendicitis Intraabdominal Infections Infections Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Ertapenem Anti-Bacterial Agents Anti-Infective Agents |