Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
- Conditions
- Appendix MassAppendicitis PerforatedAppendicitis
- Interventions
- Procedure: Non-operative treatmentProcedure: Laparoscopic appendectomyProcedure: Direct appendectomyProcedure: Open appendectomy
- Registration Number
- NCT04755179
- Lead Sponsor
- Ramon Gorter
- Brief Summary
Aim of this study is to evaluate the effect of different treatment strategies on overall complications, health related-Quality of Life (hr-QOL) and costs among two subtypes of complex appendicitis in children (\<18 years old).
Main research questions: What is the difference in overall complications at three months between:
Subgroup 1 (complex appendicitis without abscess/mass formation): Laparoscopic (LA) and open appendectomy (OA) Subgroup 2: (complex appendicitis with abscess/mass formation): Non-operative treatment (NOT) and direct appendectomy
- Detailed Description
Up till now initiated research projects worldwide mainly focus on simple appendicitis (questioning the necessity of an appendectomy). However, complex appendicitis is associated with significant morbidity (up to 30%), prolonged hospital stay and high costs. Identification of the optimal treatment strategy for children with complex appendicitis is therefore essential. Heterogeneity in the treatment of complex appendicitis still exists in daily practice and reflects the lack of high-quality data and emphasizes the need for well-designed studies. Complex appendicitis can be divided into two subtypes:
1. Complex appendicitis without mass/abscess. (subgroup 1) Although (inter)national guidelines agree that appendectomy should be usual care, the optimal approach (open or laparoscopy) is unclear. Laparoscopic appendectomy (LA) is increasingly applied both in adults (80%) and children (60%). Benefits reported for LA in children are, but not limited to, less superficial site infection (SSI), reduced length of hospital stay and significant less postoperative bowel obstruction compared with open appendectomy (OA). Reluctance for usage of LA in this specific subgroup, however, remains due to the potential higher incidence of post-appendectomy abscess formation (PAA) reported. However, the quality of studies on this topic is low and there is considerable inconsistency in results.
2. Complex appendicitis with mass/abscess. (subgroup 2) The recommendation made in our national guideline (to perform direct appendectomy in this subgroup) is not in line with the available literature. A recent Cochrane review on this topic could only include two trials and stated that no firm conclusions could be drawn. An older systematic review, including 7 studies in children, concluded that non-operative treatment (NOT) led to fewer complications, specifically SSI and PAA, when compared to direct appendectomy. Still the recommendation from our national guideline is to perform a direct appendectomy based upon good experiences in the pediatric academic centers.
In order to investigate the optimal treatment for children with complex appendicitis we will perform a nationwide, multi-center, comparative, prospective cohort study. For the purpose of this study, treatment strategies will be standardized among the participating hospitals in order to reduce heterogeneity. Prospectively derived, high quality data will be sufficient to answer the research questions regarding the optimal treatment strategy for each subtype of complex appendicitis in the pediatric population. As it is a non-randomized prospective cohort study, propensity score matching technique will be performed in order to estimate the effect of the treatments adjusted for potential confounders.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1308
Eligible for inclusion are all children <18 years old that need to undergo treatment for the suspicion of complex appendicitis. Suspicion of complex appendicitis is based upon the following predefined criteria:
4 or more points on our scoring system developed to predict complex appendicitis. The diagnostic accuracy of this scoring system is 91% (Range: 84-98%). This scoring system consists of five variables (clinical, biochemical and radiological,each awarded points). In case the total score is 4 or more points, the patient is likely to have complex appendicitis. Variables included in the scoring system are:
- Diffuse abdominal guarding (3 points)
- CRP level more than 38 mg/L (2 points)
- Signs on ultrasound / imaging indicative for complex appendicitis (2 points)
- More than one day abdominal pain (2 points)
- Temperature more than 37.5 degrees Celsius (1 point)
Or
High index of suspicion of complex appendicitis by the treating physician. If this is the case, the treating physician will make pre-treatment note upon what clinical, biochemical or radiological variable the high index of suspicion is based.
- Adult patients (=18 years old)
- Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Complex appendicitis with abscess or mass formation Direct appendectomy All children (\<18 years old) that present with a suspicion of complex appendicitis with clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system. Complex appendicitis without abscess or mass formation Open appendectomy All children (\<18 years old) that present with a suspicion of complex appendicitis without clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system. Complex appendicitis with abscess or mass formation Non-operative treatment All children (\<18 years old) that present with a suspicion of complex appendicitis with clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system. Complex appendicitis without abscess or mass formation Laparoscopic appendectomy All children (\<18 years old) that present with a suspicion of complex appendicitis without clinical or radiological signs of abscess or mass formation. Preoperative suspicion of complex appendicitis is based upon a previously developed clinical scoring system.
- Primary Outcome Measures
Name Time Method Overall complications 3 months The proportion of patients experiencing any complication within 3 months after inclusion
- Secondary Outcome Measures
Name Time Method Secondary bowel obstruction 3 months Proportion of patients with a secondary/prolonged bowel obstruction
Days absent from school, social or sports events 30 days, 3 months Number of days absent from school, social or sports events
Length of hospital stay 3 months Total length of hospital stay during follow-up due to trategy related treatment or complications
Pain medication utilization 30 days, 3 months Pain medication utilization during admission
Quality of Life questionnaire (PedsQL 4.0) at inclusion/baseline (=day 0), 30 days, 3 months QoL measured by the validated Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) (0-100 points, higher scores indicating better outcome) Labor Questionnaire (HLQ), Medical Consumption Questionnaire (iMCQ) and Productivity Consumption Questionnaire (iPCQ) and gathered actual health care cost
Superficial Site Infection 3 months Proportion of patients with a superficial site infection
Quality adjusted life months (QALM's) 3 months Quality adjusted life months calculated using outcomes 14 -17
Number of days absent from work 30 days, 3 months Number of days that parents are absent from work
Level of pain at inclusion/baseline (=day 0), 3 days, 5 days, 30 days, 3 months Level of pain measured according to the Visual Analogue Scale (0-10 points, higher scores indicating worse outcomes)
Need for appendectomy 3 months Proportion of patients not having to undergo appendectomy within 3 months after start of non-operative treatment
Recurrent appendicitis 3 months Proportion of patients experiencing recurrent appendicitis within 3 months after inclusion
Early failure of non-operative treatment 3 months Proportion of patients experiencing early failure of initial non-operative treatment
Medical costs (iMCQ) at inclusion/baseline (=day 0), 30 days, 3 months Medical costs measured by the iMedical Consumption Questionnaire
Patient satisfaction questionnaire (PSQ-18) 3 months Patient satisfaction measured by the Patient Satisfaction Questionnaire (PSQ) (0-100, higher scores indicating better outcome)
Quality of Life questionnaire (EQ-5d-Youth/EQ-5d-Proxy) at inclusion/baseline (=day 0), 30 days, 3 months QoL measured by the validated EQ-5d-Youth / EQ-5d-Proxy questionnaire (0-1 point, higher scores indicating better outcome)
Non-medical / indirect costs (iPCQ) at inclusion/baseline (=day 0), 30 days, 3 months Non-medical / indirect costs measured by the iProductivity Cost Questionnaire
Postappendectomy abscess 3 months Proportion patients with a postappendectomy abscess
Total number of extra visits 30 days, 3 months Total number of extra visits to the outpatient clinic, general pratctitioner's office or emergency department
Patient satisfaction questionnaire (Net promotor score) 3 months Patient satisfaction measured by the NET PROMOTOR SCORE (0-10, higher scores indicating better outcome)
Trial Locations
- Locations (32)
Gelre hospital
🇳🇱Apeldoorn, Netherlands
Rijnstate
🇳🇱Arnhem, Netherlands
Admiraal de Ruyter Hospital
🇳🇱Goes, Netherlands
Zaans Medical Centre
🇳🇱Zaandam, Netherlands
Northwest hospital group
🇳🇱Alkmaar, Netherlands
Tergooi
🇳🇱Blaricum, Netherlands
Haga/JKZ
🇳🇱Den Haag, Netherlands
Isala
🇳🇱Zwolle, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
Amsterdam UMC - Location AMC
🇳🇱Amsterdam, Netherlands
OLVG
🇳🇱Amsterdam, Netherlands
IJsselland Hospital
🇳🇱Capelle Aan Den IJssel, Netherlands
Catharina hospital
🇳🇱Eindhoven, Netherlands
Zuyderland MC
🇳🇱Heerlen, Netherlands
Ikazia
🇳🇱Rotterdam, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Amsterdam UMC - Location VUmc
🇳🇱Amsterdam, Netherlands
Albert Schweitzer Hospital
🇳🇱Dordrecht, Netherlands
Hospital Amstelland
🇳🇱Amstelveen, Netherlands
UMCG
🇳🇱Groningen, Netherlands
Meander MC
🇳🇱Amersfoort, Netherlands
Red Cross Hospital
🇳🇱Beverwijk, Netherlands
Amphia
🇳🇱Breda, Netherlands
Bravis Hospital
🇳🇱Bergen Op Zoom, Netherlands
Sint Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands
Dijklander
🇳🇱Hoorn, Netherlands
Laurentius
🇳🇱Roermond, Netherlands
Radboud UMC
🇳🇱Nijmegen, Netherlands
Franciscus Gasthuis & Vlietland
🇳🇱Rotterdam, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Maxima Medical Centre
🇳🇱Veldhoven, Netherlands