NCT04755179

Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population

The Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,308 (actual)
• Sponsor: Ramon Gorter · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis
• Appendix Mass
• Appendicitis Perforated

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic appendectomy	Laparoscopic appendectomy is performed according to daily practice but with the following standardized key points: 1. Conventional laparoscopy (three-trocar technique) 2. In case of purulent fluid: Suction and no peritoneal lavage procedure 3. Skelletizing of the mesoappendix (coagulation/clips according to routine practice locally) 4. Appendiceal stump closure: with two endoloops and dissected between the endoloops. In case of involvement of the appendiceal base, the use of endostapler is recommended. 5. Withdrawal of appendix: principle of abdominal wall protection is followed (trocar technique / endobag) 6. No drain placement, no nasogastric tube, and no urinary catheter routinely, only on indication. 7. Closure of wounds as appropriate
PROCEDURE	Open appendectomy	Open appendectomy will be performed according to the following standardized key points: 1. Gridiron incision at the right lower quadrant. (McBurney's point) 2. After obtaining access to the abdominal cavity the principle of abdominal wall protection will be followed. 3. The appendiceal stump will be closed by ligation, not a purse string suture. 4. Closure of wounds as appropriate
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: 1. Combination A: 1. Amoxicillin/clavulanic acid 25/2.5mg/kg 6 hourly (total 100/10 mg/kg daily. Maximum 6000/600mg a day) for children \<40 kg OR Amoxicillin/clavulanic acid 1000/200mg/kg 8 hourly (total 3000/6000 mg/kg daily) for children \> 40 kg 2. Gentamicin 7mg/kg once daily 2. Combination B: 1. Cefuroxim 25 mg/kg 6 hourly (total 100 mg/kg/day. Maximum 6gram/day) 2. Metronidazole 10mg/kg 8hourly (total 30 mg/kg/day. Maximum 4000 mg/day) In case of peri-appendicular abscess the decision can be made to perform a drainage procedure either percutaneously or surgical.
PROCEDURE	Direct appendectomy	laparoscopic or open appendectomy as described

Timeline

• Start date: 2019-08-12
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2021-02-16
• Last updated: 2024-07-30

Locations

32 sites across 1 country: Netherlands