Appendicitis Clinical Trial
Official title:
The Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
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
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04529980 -
Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis
|
N/A | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Recruiting |
NCT03522233 -
Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
|
||
Recruiting |
NCT03380793 -
A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis
|
Phase 4 | |
Recruiting |
NCT02108340 -
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis
|
N/A | |
Terminated |
NCT02029781 -
The Laparoscopic Appendicitis Score; a Multicenter Validation Study
|
N/A | |
Completed |
NCT01356641 -
Antibiotic Treatment Alone for Acute Simple Appendicitis in Children
|
N/A | |
Completed |
NCT01515293 -
Single Incision Versus Conventional Laparoscopic Appendectomy
|
Phase 3 | |
Completed |
NCT00913380 -
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
|
Phase 3 | |
Terminated |
NCT00971438 -
Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging
|
N/A | |
Completed |
NCT00530998 -
Minimally Invasive Surgery: Using Natural Orfices
|
||
Completed |
NCT00616616 -
Single Incision Laparoscopy
|
N/A | |
Completed |
NCT00195351 -
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
|
Phase 4 | |
Completed |
NCT02916134 -
Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis
|
N/A | |
Completed |
NCT04614649 -
Right Iliac Fossa Treatment-Turkey Audit
|
||
Completed |
NCT04365491 -
European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
|
||
Completed |
NCT03770897 -
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome
|
N/A | |
Completed |
NCT02507674 -
Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
|
||
Active, not recruiting |
NCT01718275 -
Non-operative Management of Early Appendicitis in Children
|
||
Terminated |
NCT01575028 -
Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
|
Phase 2 |