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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
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The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic appendectomy with follow-up MRI in patients with initially successfully treated periappendicular abscess.
Periappendicular abscess is generally initially treated conservatively with antibiotic therapy and if necessary, drainage. Operative treatment in the acute abscess phase is associated with increased morbidity and thus complicated appendicitis with a periappendicular abscess is initially treated conservatively. However, there is debate on whether interval appendectomy is required.
After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular abscess, patients enrolled in the PeriAPPAC study are randomised either to interval appendectomy or to follow-up with MRI at two months after the initial treatment. All patients also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the MRI (outpatient visit at endoscopy unit with information on the MRI).
The primary endpoint is the treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up.
The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital and Seinäjoki Central Hospital.
The PeriAPPAC trial is a prospective randomised study comparing interval laparoscopic appendectomy with follow-up MRI in patients with initially successfully treated periappendicular abscess.
Periappendicular abscess is generally initially treated conservatively with antibiotic therapy and if necessary, drainage. Operative treatment in the acute abscess phase is associated with increased morbidity and thus complicated appendicitis with a periappendicular abscess is initially treated conservatively. However, there is debate on whether interval appendectomy is required.
After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular abscess, patients enrolled in the PeriAPPAC study are randomised either to interval appendectomy or to follow-up with MRI at two months after the initial treatment. All patients also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the MRI (outpatient visit at endoscopy unit with information on the MRI).
The primary endpoint is the treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up.
The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital and Seinäjoki Central Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interval Appendectomy | Active Comparator | The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary. Interval appendectomy is performed at two months after the primary treatment, all patients also undergo colonoscopy prior to appendectomy. |
|
| Follow-up with MRI | Active Comparator | The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary. The patients undergo abdominal magnetic resonance imaging at two months after the primary treatment, all patients also undergo colonoscopy right after the MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interval appendectomy | Procedure | Laparoscopic appendectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | Treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and successful appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up | One year after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Possible appendiceal or colon tumours | The incidence of possible tumours | 1-10 years |
| Possible diagnosis of Crohn's disease | The incidence of possible Crohn's disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulina Salminen, MD, PhD | Turku University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30484824 | Derived | Mallinen J, Rautio T, Gronroos J, Rantanen T, Nordstrom P, Savolainen H, Ohtonen P, Hurme S, Salminen P. Risk of Appendiceal Neoplasm in Periappendicular Abscess in Patients Treated With Interval Appendectomy vs Follow-up With Magnetic Resonance Imaging: 1-Year Outcomes of the Peri-Appendicitis Acuta Randomized Clinical Trial. JAMA Surg. 2019 Mar 1;154(3):200-207. doi: 10.1001/jamasurg.2018.4373. |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Follow-up with MRI |
| Procedure |
Abdominal MRI |
|
| 1-10 years |
| The length of hospital stay | Length of hospital stay | up to one year |
| Sick leave | Sick leave (days) | up to one year |
| Overall morbidity | Complications related to disease / intervention | Up to 10 years, time points 1, 3, 5 and 10 years |
| Mortality | Mortality | Up to 10 years |
| Treatment costs | Overall treatment costs | Up to 10 years |