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

CompletedOBSERVATIONAL
Enrollment

1,308

Participants

Timeline

Start Date

August 12, 2019

Primary Completion Date

July 3, 2024

Study Completion Date

July 3, 2024

Conditions
AppendicitisAppendix MassAppendicitis Perforated
Interventions
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

Trial Locations (32)

Unknown

Northwest hospital group, Alkmaar

Flevoziekenhuis, Almere Stad

Meander MC, Amersfoort

Hospital Amstelland, Amstelveen

Amsterdam UMC - Location AMC, Amsterdam

Amsterdam UMC - Location VUmc, Amsterdam

OLVG, Amsterdam

Gelre hospital, Apeldoorn

Rijnstate, Arnhem

Bravis Hospital, Bergen op Zoom

Red Cross Hospital, Beverwijk

Tergooi, Blaricum

Amphia, Breda

IJsselland Hospital, Capelle aan den IJssel

Albert Schweitzer Hospital, Dordrecht

Catharina hospital, Eindhoven

Admiraal de Ruyter Hospital, Goes

UMCG, Groningen

Spaarne Gasthuis, Haarlem

Zuyderland MC, Heerlen

Dijklander, Hoorn

Sint Antonius Hospital, Nieuwegein

Radboud UMC, Nijmegen

Laurentius, Roermond

Erasmus MC, Rotterdam

Franciscus Gasthuis & Vlietland, Rotterdam

Ikazia, Rotterdam

Maasstad Hospital, Rotterdam

Haga/JKZ, The Hague

Maxima Medical Centre, Veldhoven

Zaans Medical Centre, Zaandam

Isala, Zwolle

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Amsterdam UMC, location VUmc

OTHER

lead

Ramon Gorter

OTHER

NCT04755179 - Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population | Biotech Hunter | Biotech Hunter