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

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

Conditions

• Appendicitis
• Appendix Mass
• Appendicitis 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

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Ramon Gorter

  lead OTHER

Principal Investigators

• Ramon Gorter, MD PhD · Amsterdam UMC

Eligibility

Min Age

0 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-12

Primary Completion

2024-07-03

Completion

2024-07-03

Countries

• Netherlands

Study Locations