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Stapler or endoloop closure of the appendiceal stump in laparoscopic appendectomy.


- candidate number7935
- NTR NumberNTR2289
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-apr-2010
- Secondary IDs80-82310-97-10035 ZonMW
- Public TitleStapler or endoloop closure of the appendiceal stump in laparoscopic appendectomy.
- Scientific TitleStapler or endoloop closure of the appendiceal stump in laparoscopic appendectomy.
- ACRONYMSTELLA
- hypothesisSuperficial and intra-abdominal infections: 8% in the standard loop group to 4% in the endoloop closure group.
- Healt Condition(s) or Problem(s) studiedAppendectomy, Laparoscopy, Appendicitis
- Inclusion criteriaAcute appendicitis.
- Exclusion criteria1. Perforation of the appendiceal base;
2. Inflammation of the caecum.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2010
- planned closingdate1-sep-2013
- Target number of participants1200
- Interventions1. Laparoscopic appendectomy with endostapled stump closure;
2. Laparoscopic appendectomy with endolooped stump closure.
- Primary outcomeSuperficial and intra-abdominal infections.
- Secondary outcome1. 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).
- TimepointsFollow-up at two, four and twelve weeks.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES H.A. Swank
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.A. Bemelman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryLaparoscopic 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.
- Main changes (audit trail)
- RECORD14-apr-2010 - 10-apr-2011


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