Laparoscopic versus open appendectomy

ISRCTN	ISRCTN92257749
DOI	https://doi.org/10.1186/ISRCTN92257749
Protocol serial number	N/A
Sponsor	University of Witwatersrand (South Africa)
Funder	Department of Surgery, University of Witwatersrand (South Africa)

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

Primary study design	Interventional
Study design	Prospective single-centre randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Whether the duration of the symptoms has any effect on the outcome between the two procedures
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
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

2 Edward Drive

Johannesburg
1609
South Africa

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes