No registrations found.
ID
Source
Brief title
Health condition
Appendicitis
Appendectomy
Appendicectomy
Laparoscopic appendectomy
Appendectomie
Laparoscopische appendectomie
Sponsors and support
Amsterdam
Intervention
Outcome measures
Primary outcome
Superficial and intra-abdominal infections.
Secondary outcome
1. Postoperative quality of life at two, four and twelve weeks (SF-36, EQ-5D);
2. Operating time;
3. Conversion rate;
4. Overall morbidity;
5. Hospital stay;
6. Return to work or school;
7. Direct and indirect medical costs (direct: equipment, operating time, infectious complications and indirect: return to work, daily activity).
Background summary
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.
Study objective
Superficial and intra-abdominal infections: 8% in the standard loop group to 4% in the endoloop closure group.
Study design
Follow-up at two, four and twelve weeks.
Intervention
1. Laparoscopic appendectomy with endostapled stump closure;
2. Laparoscopic appendectomy with endolooped stump closure.
Postbus 22660
H.A. Swank
Heelkunde G4-144
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+31 205664580
h.a.swank@amc.uva.nl
Postbus 22660
H.A. Swank
Heelkunde G4-144
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+31 205664580
h.a.swank@amc.uva.nl
Inclusion criteria
Acute appendicitis.
Exclusion criteria
1. Perforation of the appendiceal base;
2. Inflammation of the caecum.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2165 |
NTR-old | NTR2289 |
Other | ZonMW : 80-82310-97-10035 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |