The Treatment of Periappendicular Abscess After the Acute Phase
- Conditions
- Periappendicular Abscess
- Interventions
- Procedure: Interval appendectomyProcedure: Follow-up with MRI
- Registration Number
- NCT03013686
- Lead Sponsor
- Turku University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Age 18-60 years
- CT- or MRI-diagnosed periappendicular abscess, that has initially undergone successful conservative treatment with antibiotic therapy and drainage, if necessary
- Suspicion of a tumour on CT or MRI
- Age under 18 years or over 60 years
- Pregnancy or lactating
- Allergy to contrast media or iodine
- Renal insufficiency
- Metformin medication (DM)
- Unsuccessful initial conservative treatment of periappendicular abscess
- Lack of co-operation (unable to give consent)
- A severe medical condition
- Previous acute appendicitis treated conservatively with antibiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interval Appendectomy Interval appendectomy 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 Follow-up with MRI 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.
- Primary Outcome Measures
Name Time Method Treatment success One year after the intervention 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
- Secondary Outcome Measures
Name Time Method Possible appendiceal or colon tumours 1-10 years The incidence of possible tumours
The length of hospital stay up to one year Length of hospital stay
Possible diagnosis of Crohn's disease 1-10 years The incidence of possible Crohn's disease
Overall morbidity Up to 10 years, time points 1, 3, 5 and 10 years Complications related to disease / intervention
Sick leave up to one year Sick leave (days)
Treatment costs Up to 10 years Overall treatment costs
Mortality Up to 10 years Mortality