Clinical trial NCT03013686: The Treatment of Periappendicular Abscess After the Acute Phase
Official title: The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC): a Randomized Clinical Trial Interval Appendectomy Versus Follow-up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periappendicular Abscess
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Oulu University Hospital
First posted: 2017-01-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* CT- or MRI-diagnosed periappendicular abscess, that has initially undergone successful conservative treatment with antibiotic therapy and drainage, if necessary

Exclusion Criteria:

* 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

Primary outcomes:
measure: Treatment success
timeFrame: One year after the intervention
Secondary outcomes:
measure: Possible appendiceal or colon tumours
timeFrame: 1-10 years
measure: Possible diagnosis of Crohn's disease
timeFrame: 1-10 years
measure: The length of hospital stay
timeFrame: up to one year
measure: Sick leave
timeFrame: up to one year
measure: Overall morbidity
timeFrame: Up to 10 years, time points 1, 3, 5 and 10 years
measure: Mortality
timeFrame: Up to 10 years
measure: Treatment costs
timeFrame: Up to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Turku University Hospital
name: Paulina Salminen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.