The Treatment of Periappendicular Abscess After the Acute Phase

Periappendicular Abscess Clinical Trial

— PeriAPPAC  

Official title:

The Treatment of Periappendicular Abscess After the Acute Phase (PeriAPPAC): a Randomized Clinical Trial Interval Appendectomy Versus Follow-up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03013686
• Other study ID #: PeriAPPAC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2013
• Est. completion date: December 31, 2030

Study information

• Verified date: November 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2030
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Periappendicular Abscess

Intervention

Procedure:
• Interval appendectomy
Laparoscopic appendectomy
• Follow-up with MRI
Abdominal MRI

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Oulu University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Possible appendiceal or colon tumours	The incidence of possible tumours	1-10 years
Secondary	Possible diagnosis of Crohn's disease	The incidence of possible Crohn's disease	1-10 years
Secondary	The length of hospital stay	Length of hospital stay	up to one year
Secondary	Sick leave	Sick leave (days)	up to one year
Secondary	Overall morbidity	Complications related to disease / intervention	Up to 10 years, time points 1, 3, 5 and 10 years
Secondary	Mortality	Mortality	Up to 10 years
Secondary	Treatment costs	Overall treatment costs	Up to 10 years