Laparoscopic versus open appendectomy
| 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
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
Scientific
2 Edward Drive
Dowerglen
Edenvale
Johannesburg
1609
South Africa
Study information
| Study design | Prospective single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the conatct details below to request a patient information sheet |
| Scientific title | Laparoscopic versus open procedure for perforated appendix: a randomized controlled trial |
| Study objectives | In 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) studied | Appendicitis |
| Intervention | Open appendicetomy (OA) versus laparoscopic appendicetomy (LA) |
| Intervention type | Other |
| 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 study start date | 05/12/2011 |
| Completion date | 31/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 patients |
| Key inclusion criteria | All potential patients presenting with appendicitis at Chris Hani Baragwanath Hospital, Johannesburg, South Africa |
| Key exclusion criteria | 1. Patients less than 12 years of age 2. Those who have undergone previous abdominal surgery 3. Pregnant patients |
| Date of first enrolment | 05/12/2011 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- South Africa
Study participating centre
1609
South Africa
Sponsor information
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" |
https://ror.org/03rp50x72 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
