Superficial and intra-abdominal infections: 8% in the standard loop group to 4% in the endoloop closure group.
ID
Bron
Verkorte titel
Aandoening
Appendicitis
Appendectomy
Appendicectomy
Laparoscopic appendectomy
Appendectomie
Laparoscopische appendectomie
Ondersteuning
Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Superficial and intra-abdominal infections.
Achtergrond van het onderzoek
Laparoscopic appendectomy is the treatment of choice for appendicitis provided sufficient laparoscopic expertise is available. Infectious complications (wound infection and intra-abdominal abscesses) following laparoscopic appendectomy are however not uncommon and can lead to reinterventions, additional treatment and prolonged hospital stay. A safer and easier stump closure technique using an endostapler rather than the standard loop closure has shown to be effective in reducing the number of infections complications but is associated with higher costs (+/- 700€). In a cost-effectiveness multicenter study alongside a randomized trial we will determine the clinical effectiveness, quality of life and costs associated with both approaches.
Primary outcome parameters are superficial and intra-abdominal infections. Secondary outcome parameters are postoperative quality of life at 2, 4 and 12 weeks (SF-36, EQ-5D) operating time, conversion rate, overall morbidity, hospital stay, return to work or school, direct and indirect medical costs. A sample size of 600 patients per treatment arm will be able to detect a difference in superficial and intra-abdominal infections from 8% in the standard loop group to 4% in the endoloop closure group.
Doel van het onderzoek
Superficial and intra-abdominal infections: 8% in the standard loop group to 4% in the endoloop closure group.
Onderzoeksopzet
Follow-up at two, four and twelve weeks.
Onderzoeksproduct en/of interventie
1. Laparoscopic appendectomy with endostapled stump closure;
2. Laparoscopic appendectomy with endolooped stump closure.
Publiek
Postbus 22660
H.A. Swank
Heelkunde G4-144
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+31 205664580
h.a.swank@amc.uva.nl
Wetenschappelijk
Postbus 22660
H.A. Swank
Heelkunde G4-144
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+31 205664580
h.a.swank@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Acute appendicitis.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Perforation of the appendiceal base;
2. Inflammation of the caecum.
Opzet
Deelname
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