Appendectomy vs. Symptomatic Treatment in Uncomplicated Acute Appendicitis Among Pediatric Patients

NCT05289713 | Unknown DMC

• 1 other identifier: APPSYPP
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. Patients are recruited from all five Finnish university hospitals. Inclusion criteria are: 1) age 7-15 years, 2) imaging-confirmed uncomplicated acute appendicitis (no appendicolith, perforation, abscess, or tumor suspicion), and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency appendectomy or symptomatic treatment. In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization. In order to ensure patient safety, symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice. Primary outcome is treatment success at 30 days defined by not fulfilling any of the treatment failure criteria. In the surgery group, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In the symptomatic treatment group, treatment failure is defined as inability to discharge from hospital without appendectomy within 48 hours after randomization with a finding of histopathologically inflamed appendix, appendectomy during the initial hospital stay due to clinical progression of appendicitis with histopathologically and surgically confirmed complicated acute appendicitis, appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or any complication of appendicitis requiring general anesthesia. Predefined secondary outcomes include later appendectomies, recurrence of histopathologically confirmed appendicitis and associated symptoms, postintervention complications, return to normal daily activities, quality of, resolution of appendicitis in US imagining after 1 month of symptomatic treatment, comparison of US and MRI findings at presentation, and differences in serum biomarkers and fecal microbiota composition.

Conditions

Appendicitis

Keywords

uncomplicated acute appendicitis; symptomatic treatment; spontaneous resolution

Outcome Measures

Primary Outcomes (1)

• Treatment success at 30d follow-up.

  Treatment success is defined by not fulfilling any of the following treatment failure criteria. Treatment failure in the surgery group: * Normal histopathology of the removed appendix. * Any complication of acute appendicitis or surgery requiring general anesthesia (GA) within 30 d. Treatment failure in the symptomatic treatment group: * Inability to discharge from hospital within 48 h after randomization without appendectomy due to persisting symptoms and unmet discharge criteria with a finding of histopathologically inflamed appendix. * Appendectomy due to clinical suspicion of progressive appendicitis including increasing pain not responding to the defined non-opioid analgesics during the initial hospital stay with a finding of histopathologically and surgically confirmed complicated acute appendicitis. * Appendectomy with a histopathologically confirmed acute appendicitis after hospital discharge within 30 d. * Any complication of AA reiring GA within 30 d.

  30 days

Secondary Outcomes (7)

• Postintervention complications

  1 year

• Recurrent appendicitis

  1 year

• Recurrent symptoms

  1 year

• Recovery of normal daily activities

  1 year

• QoL

  1 year

Other Outcomes (1)

• Serum biomarkers and fecal microbiota

  1 month

Study Arms (2)

Surgery

ACTIVE COMPARATOR

In the surgery group, patients undergo laparoscopic appendectomy within 18 hours after randomization.

Procedure: appendectomy

Symptomatic treatment

ACTIVE COMPARATOR

Symptomatically treated patients are hospitalized for at least 24 hours, and receive intravenous fluids and analgesics according to standard clinical practice.

Procedure: appendectomy

Interventions

appendectomy PROCEDURE

Laparoscopic appendectomy is performed within 18 hours after randomization in the surgery group. Patients in the symptomatic treatment group are carefully monitored and the same intervention (laparoscopic appendectomy) is performed in case of treatment failure.

Surgery; Symptomatic treatment

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 7-15 years
• clinical diagnosis of uncomplicated acute appendicitis confirmed by US and/or MRI: adequately visualized appendix with a diameter of 6.1-11.0 mm without evidence of perforation, abscess, appendicolith or tumor suspicion
• CRP ≤ 65 mg/l

You may not qualify if:

• inability to give informed consent
• age under 7 or over 15 years
• antibiotic administration within 14 days prior to enrolment
• any previous treatment for acute appendicitis
• severe nausea and/or vomiting preventing oral fluid intake
• systemic disease potentially compromising the safety of symptomatic treatment of acute appendicitis (e.g. type 2 diabetes, malignancy, immune deficiency, or a medical condition requiring immunosuppressant medication)
• diffuse peritonitis or complicated acute appendicitis at imaging (perforation, abscess, appendicolith or tumor suspicion)
• inadequately visualized appendix
• age and sex adjusted BMI over 27 kg/m2 and no MRI performed
• CRP \> 65 mg/l.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Turku University Hospital: collaborator
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Oulu University Hospital: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Related Publications (1)

• Puputti J, Suominen JS, Luoto T, Hiltunen P, Ripatti L, Nikoskelainen M, Nuutinen S, Sinikumpu JJ, Tahkola E, Porela-Tiihonen S, Hurme S, Salminen P, Pakarinen MP. A randomized, controlled multicenter feasibility pilot trial on imaging confirmed uncomplicated acute appendicitis: Appendectomy vs. symptomatic treatment in pediatric patients (the APPSYPP) trial study protocol. Contemp Clin Trials. 2022 Dec;123:106970. doi: 10.1016/j.cct.2022.106970. Epub 2022 Oct 22.

  PMID: 36280033 DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Janne Suominen, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janne Suominen, MD, PhD

CONTACT

+358504272977; janne.suominen@hus.fi

Jenny Puputti

CONTACT

jenny.puputti@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 21, 2022
• Study Start: March 10, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years
• Access Criteria: Only partipating researchers have access to data.

Locations

FI (1)