Condition category
Digestive System
Date applied
04/12/2011
Date assigned
18/01/2012
Last edited
28/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr John Thomson

ORCID ID

Contact details

2 Edward Drive
Dowerglen
Edenvale
Johannesburg
1609
South Africa

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 measures

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

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

http://www.wits.ac.za/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25318368

Publication citations

  1. 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.

Additional files

Editorial Notes