Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
CAPP
The Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
1 other identifier
observational
1,308
1 country
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2024
CompletedJuly 30, 2024
July 1, 2024
4.9 years
January 29, 2021
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall complications
The proportion of patients experiencing any complication within 3 months after inclusion
3 months
Secondary Outcomes (19)
Postappendectomy abscess
3 months
Superficial Site Infection
3 months
Secondary bowel obstruction
3 months
Days absent from school, social or sports events
30 days, 3 months
Number of days absent from work
30 days, 3 months
- +14 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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
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
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.
laparoscopic or open appendectomy as described
Eligibility Criteria
All children that present with a preoperative suspicion of complex appendicitis. This suspicion is based on 4 points or more on the abovementioned complex appendicitis scoring system OR a high index of suspicion of complex appendicitis by the treating physician.
You may qualify if:
- 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)
- 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.
You may not qualify if:
- Adult patients (=18 years old)
- Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramon Gorterlead
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Amsterdam UMC, location VUmccollaborator
Study Sites (32)
Northwest hospital group
Alkmaar, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander MC
Amersfoort, Netherlands
Hospital Amstelland
Amstelveen, Netherlands
Amsterdam UMC - Location AMC
Amsterdam, Netherlands
Amsterdam UMC - Location VUmc
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Gelre hospital
Apeldoorn, Netherlands
Rijnstate
Arnhem, Netherlands
Bravis Hospital
Bergen op Zoom, Netherlands
Red Cross Hospital
Beverwijk, Netherlands
Tergooi
Blaricum, Netherlands
Amphia
Breda, Netherlands
IJsselland Hospital
Capelle aan den IJssel, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Catharina hospital
Eindhoven, Netherlands
Admiraal de Ruyter Hospital
Goes, Netherlands
UMCG
Groningen, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Zuyderland MC
Heerlen, Netherlands
Dijklander
Hoorn, Netherlands
Sint Antonius Hospital
Nieuwegein, Netherlands
Radboud UMC
Nijmegen, Netherlands
Laurentius
Roermond, Netherlands
Erasmus MC
Rotterdam, Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
Ikazia
Rotterdam, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Haga/JKZ
The Hague, Netherlands
Maxima Medical Centre
Veldhoven, Netherlands
Zaans Medical Centre
Zaandam, Netherlands
Isala
Zwolle, Netherlands
Related Publications (1)
van Amstel P, Bakx R, van der Lee JH, van der Weide MC, Eekelen RV, Derikx JPM, van Heurn ELW, Gorter RR; CAPP collaborative study group. Identification of the optimal treatment strategy for complex appendicitis in the paediatric population: a protocol for a multicentre prospective cohort study (CAPP study). BMJ Open. 2022 Feb 17;12(2):e054826. doi: 10.1136/bmjopen-2021-054826.
PMID: 35177453DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramon Gorter, MD PhD
Amsterdam UMC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 16, 2021
Study Start
August 12, 2019
Primary Completion
July 3, 2024
Study Completion
July 3, 2024
Last Updated
July 30, 2024
Record last verified: 2024-07