Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population (CAPP)
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|ClinicalTrials.gov Identifier: NCT04755179|
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : February 16, 2021
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
|Condition or disease||Intervention/treatment|
|Appendicitis Appendix Mass Appendicitis Perforated||Procedure: Laparoscopic appendectomy Procedure: Open appendectomy Procedure: Non-operative treatment Procedure: Direct appendectomy|
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:
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1308 participants|
|Official Title:||The Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population|
|Actual Study Start Date :||August 12, 2019|
|Estimated Primary Completion Date :||August 12, 2022|
|Estimated Study Completion Date :||August 12, 2022|
Complex appendicitis without abscess or mass formation
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.
Procedure: Laparoscopic appendectomy
Laparoscopic appendectomy is performed according to daily practice but with the following standardized key points:
Procedure: Open appendectomy
Open appendectomy will be performed according to the following standardized key points:
Complex appendicitis with abscess or mass formation
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.
Procedure: Non-operative treatment
Non-operative treatment consisting of administration of intravenous antibiotics with or without drainage procedures (in case of an abscess), reserving an appendectomy for those not responding or with recurrent disease.
One of the two antibiotic regiments:
Procedure: Direct appendectomy
laparoscopic or open appendectomy as described
- Overall complications [ Time Frame: 3 months ]The proportion of patients experiencing any complication within 3 months after inclusion
- Postappendectomy abscess [ Time Frame: 3 months ]Proportion patients with a postappendectomy abscess
- Superficial Site Infection [ Time Frame: 3 months ]Proportion of patients with a superficial site infection
- Secondary bowel obstruction [ Time Frame: 3 months ]Proportion of patients with a secondary/prolonged bowel obstruction
- Days absent from school, social or sports events [ Time Frame: 30 days, 3 months ]Number of days absent from school, social or sports events
- Number of days absent from work [ Time Frame: 30 days, 3 months ]Number of days that parents are absent from work
- Total number of extra visits [ Time Frame: 30 days, 3 months ]Total number of extra visits to the outpatient clinic, general pratctitioner's office or emergency department
- Length of hospital stay [ Time Frame: 3 months ]Total length of hospital stay during follow-up due to trategy related treatment or complications
- Level of pain [ Time Frame: 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)
- Pain medication utilization [ Time Frame: 30 days, 3 months ]Pain medication utilization during admission
- Need for appendectomy [ Time Frame: 3 months ]Proportion of patients not having to undergo appendectomy within 3 months after start of non-operative treatment
- Recurrent appendicitis [ Time Frame: 3 months ]Proportion of patients experiencing recurrent appendicitis within 3 months after inclusion
- Early failure of non-operative treatment [ Time Frame: 3 months ]Proportion of patients experiencing early failure of initial non-operative treatment
- Quality of Life questionnaire (EQ-5d-Youth/EQ-5d-Proxy) [ Time Frame: 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)
- Quality of Life questionnaire (PedsQL 4.0) [ Time Frame: 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
- Medical costs (iMCQ) [ Time Frame: at inclusion/baseline (=day 0), 30 days, 3 months ]Medical costs measured by the iMedical Consumption Questionnaire
- Non-medical / indirect costs (iPCQ) [ Time Frame: at inclusion/baseline (=day 0), 30 days, 3 months ]Non-medical / indirect costs measured by the iProductivity Cost Questionnaire
- Quality adjusted life months (QALM's) [ Time Frame: 3 months ]Quality adjusted life months calculated using outcomes 14 -17
- Patient satisfaction questionnaire (PSQ-18) [ Time Frame: 3 months ]Patient satisfaction measured by the Patient Satisfaction Questionnaire (PSQ) (0-100, higher scores indicating better outcome)
- Patient satisfaction questionnaire (Net promotor score) [ Time Frame: 3 months ]Patient satisfaction measured by the NET PROMOTOR SCORE (0-10, higher scores indicating better outcome)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755179
|Contact: Ramon Gorter, MD PhDemail@example.com|
|Contact: Paul van Amstel, MDfirstname.lastname@example.org|
|Principal Investigator:||Ramon Gorter, MD PhD||Amsterdam UMC|