ISRCTN ISRCTN92257749
DOI https://doi.org/10.1186/ISRCTN92257749
Secondary identifying numbers N/A
Submission date
04/12/2011
Registration date
18/01/2012
Last edited
28/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr John Thomson
Scientific

2 Edward Drive
Dowerglen
Edenvale
Johannesburg
1609
South Africa

Study information

Study designProspective single-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the conatct details below to request a patient information sheet
Scientific titleLaparoscopic versus open procedure for perforated appendix: a randomized controlled trial
Study objectivesIn the treatment of perforated appendicitis, laparoscopic appendicetomy is associated with lower morbidity than open appendicetomy.
Ethics approval(s)Human Research Medical Ethics Committee, University of the Witwatersrand, Johannesburg, 27/11/2011, ref: M110730
Health condition(s) or problem(s) studiedAppendicitis
InterventionOpen appendicetomy (OA) versus laparoscopic appendicetomy (LA)
Intervention typeOther
Primary outcome measure1. 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 measuresWhether the duration of the symptoms has any effect on the outcome between the two procedures
Overall study start date05/12/2011
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100 patients
Key inclusion criteriaAll potential patients presenting with appendicitis at Chris Hani Baragwanath Hospital, Johannesburg, South Africa
Key exclusion criteria1. Patients less than 12 years of age
2. Those who have undergone previous abdominal surgery
3. Pregnant patients
Date of first enrolment05/12/2011
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • South Africa

Study participating centre

2 Edward Drive
Johannesburg
1609
South Africa

Sponsor information

University of Witwatersrand (South Africa)
Hospital/treatment centre

c/o Prof Thifheli Luvhengo
Department of Surgery
Baragwanath Hospital
R68 Old Potchefstroom Road
PO Bertsham
Johannesburg
2013
South Africa

Website http://www.wits.ac.za/
ROR logo "ROR" https://ror.org/03rp50x72

Funders

Funder type

Hospital/treatment centre

Department of Surgery, University of Witwatersrand (South Africa)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2015 Yes No