Plain English Summary
Background and study aims
Appendicitis is a painful swelling of the appendix, a finger-like pouch connected to the large intestine. It is traditionally classified as uncomplicated or complicated, and is treated by removal of the appendix, known as an appendectomy or appendicectomy, which is the most commonly performed surgical procedure. Appendicectomy can be performed by one of two methods. Laparoscopic appendicectomy (LA) involves making several small cuts in your abdomen through which special surgical instruments are inserted. Open appendicectomy (OA) involves making a single larger cut in the abdomen. Currently the Department of Surgery at Chris Hani Baragwanath Hospital, Johannesburg, South Africa, practises both OA and LA in the treatment of perforated appendicitis (burst appendix). To date there have been no studies comparing outcomes between OA and LA in perforated appendicitis. The aim of this study is to compare the intra-operative duration, the rate of wound sepsis, the rate of relook, the length of hospital stay and the rate of re-admissions between the OA and LA groups. Additionally we aim to look at whether the duration of the symptoms has any effect on the outcome between the two procedures.
Who can participate?
Patients presenting with acute abdomens suspected to be caused by perforated appendicitis at Chris Hani Baragwanath Hospital.
What does the study involve?
Participants will be randomly allocated to undergo either OA or LA. A team of senior surgeons capable of doing both OA and LA will perform the surgery. Surgeons will perform standardized procedures in both subgroups as per current clinical guidelines.
What are the possible benefits and risks of participating?
As this study will be comparing the outcomes of two different emergency surgical procedures, patients will be subjected to the risks which are associated with the surgical procedures. It must be noted that all patients recruited into the study need emergency surgery and thus inclusion in the study per se adds no additional risk factors to patients.
Where is the study run from?
Chris Hani Baragwanath Hospital, Johannesburg, South Africa.
When is the study starting and how long is it expected to run for?
The study began in December 2011 and ran for about 6 months.
Who is funding the study?
There is no sponsor for the above trial. Should any minor costs be incurred they will be funded by the Department of Surgery, University of Witwatersrand, Johannesburg, South Africa.
Who is the main contact?
Dr John Thomson
drjohnthomson@gmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Laparoscopic versus open procedure for perforated appendix: a randomized controlled trial
Acronym
Study hypothesis
In the treatment of perforated appendicitis, laparoscopic appendicetomy is associated with lower morbidity than open appendicetomy.
Ethics approval
Human Research Medical Ethics Committee, University of the Witwatersrand, Johannesburg, 27/11/2011, ref: M110730
Study design
Prospective single-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the conatct details below to request a patient information sheet
Condition
Appendicitis
Intervention
Open appendicetomy (OA) versus laparoscopic appendicetomy (LA)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. 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
Secondary outcome measures
Whether the duration of the symptoms has any effect on the outcome between the two procedures
Overall trial start date
05/12/2011
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All potential patients presenting with appendicitis at Chris Hani Baragwanath Hospital, Johannesburg, South Africa
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients
Participant exclusion criteria
1. Patients less than 12 years of age
2. Those who have undergone previous abdominal surgery
3. Pregnant patients
Recruitment start date
05/12/2011
Recruitment end date
31/05/2012
Locations
Countries of recruitment
South Africa
Trial participating centre
2 Edward Drive
Johannesburg
1609
South Africa
Sponsor information
Organisation
University of Witwatersrand (South Africa)
Sponsor details
c/o Prof Thifheli Luvhengo
Department of Surgery
Baragwanath Hospital
R68 Old Potchefstroom Road
PO Bertsham
Johannesburg
2013
South Africa
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Department of Surgery, University of Witwatersrand (South Africa)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25318368
Publication citations
-
Results
Thomson JE, Kruger D, Jann-Kruger C, Kiss A, Omoshoro-Jones JA, Luvhengo T, Brand M, Laparoscopic versus open surgery for complicated appendicitis: a randomized controlled trial to prove safety., Surg Endosc, 2014, doi: 10.1007/s00464-014-3906-y.