|
ISRCTN
|
ISRCTN92257749
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Laparoscopic versus open appendectomy
|
|
Scientific title
|
Laparoscopic versus open procedure for perforated appendix: a randomized controlled trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
In the treatment of perforated appendicitis, laparoscopic appendicetomy is associated with lower morbidity than open appendicetomy
|
|
Lay summary
|
Lay summary under review
|
|
Ethics approval
|
Human Research Medical Ethics Committee, University of the Witwatersrand, Johannesburg, 27 November 2011 ref: M110730
|
|
Study design
|
Prospective single-centre randomized controlled trial
|
|
Countries of recruitment
|
South Africa
|
|
Disease/condition/study domain
|
Appendicitis
|
|
Participants - inclusion criteria
|
All potential patients presenting with appendicitis at Chris Hani Baragwanath Hospital, Johannesburg, South Africa
|
|
Participants - exclusion criteria
|
1. Patients less than 12 years of age
2. Those who have undergone previous abdominal surgery
3. Pregnant patients
|
|
Anticipated start date
|
05/12/2011
|
|
Anticipated end date
|
31/05/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the conatct details below to request a patient information sheet
|
|
Target number of participants
|
100 patients
|
|
Interventions
|
Open appendicetomy (OA) versus laparoscopic appendicetomy (LA)
|
|
Primary outcome measure(s)
|
1. To compare the intra-operative duration
2. The rate of wound sepsis
3. The rate of re-look (the number of re-operations required as a result of the appendicitis or subsequent sequel of the appendicitis)
4. The length of hospital stay
5. The rate of re-admissions between the OA and LA groups
|
|
Secondary outcome measure(s)
|
Whether the duration of the symptoms has any effect on the outcome between the two procedures
|
|
Sources of funding
|
Department of Surgery, University of Witwatersrand (South Africa)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
John
Thomson
|
|
Address
|
2 Edward Drive
Dowerglen
Edenvale
|
|
City/town
|
Johannesburg
|
|
Zip/Postcode
|
1609
|
|
Country
|
South Africa
|
|
Sponsor
|
University of Witwatersrand (South Africa)
|
|
Address
|
c/o Prof Thifheli Luvhengo
Department of Surgery
Baragwanath Hospital
R68 Old Potchefstroom Road
PO Bertsham
|
|
City/town
|
Johannesburg
|
|
Zip/Postcode
|
2013
|
|
Country
|
South Africa
|
|
Sponsor website:
|
http://www.wits.ac.za/
|
|
Date applied
|
04/12/2011
|
|
Last edited
|
18/01/2012
|
|
Date ISRCTN assigned
|
18/01/2012
|
