Single-incision appendectomy: an equally safe alternative?
| ISRCTN | ISRCTN97312223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97312223 |
| Secondary identifying numbers | 1793/2021 |
- Submission date
- 31/12/2023
- Registration date
- 15/01/2024
- Last edited
- 10/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Surgeons constantly strive to refine their techniques into smaller and more effective incisions while ensuring the patient is safe and receives the necessary treatment. This study aims to prove that single-incision extracorporeal appendectomy (removal of the appendix) is the same as performing conventional three-port (three incisions) appendectomy. This will provide a foundation for future studies to compare cosmetic outcomes as well as rates of surgical site hernias.
Who can participate?
Patients aged 18 to 80 years diagnosed with acute appendicitis (inflammation of the appendix) at the study site (Mubarak Alkabeer Hospital)
What does the study involve?
The study involves an operation in which an incision through the umbilicus (belly button) will be made, the appendix will be delivered through that incision and excised and the wound will be closed. This will be compared to the traditional minimally invasive method of making three incisions (one above the umbilicus and two others on the left and lower side of the body) and inserting trochars or ports (the device that allows laparoscopic surgical instruments to be used) and proceeding with surgery using that method.
What are the possible benefits and risks of participating?
The additional benefit is a more cosmetic surgery compared to traditional surgery. The possible risk is an increased rate of wound opening, surgical site infection, and possibly pain.
Where is the study run from?
Mubarak Alkabeer Hospital (Kuwait)
When is the study starting and how long is it expected to run for?
October 2020 to October 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Omar Al-Qabandi, oaalqabandi@moh.gov.kw
2. Dr Salman Alsafran, salman.alsafran@ku.edu.kw
Contact information
Public, Scientific, Principal Investigator
Hawalli Governorate \ Ministries Area - Block 1, Khalid Ben AbdulAziz Street
Kuwait City
91711
Kuwait
 ORCID ID |
0000-0001-9581-6050 |
|---|---|
| Phone | +965 (0)65008300 |
| Salman.alsafran@ku.edu.kw |
Study information
| Study design | Single-center retrospective case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Single-incision extra-corporeal appendectomy compared to conventional multi-ports appendectomy: a case-control study |
| Study acronym | SIEA |
| Study objectives | Single incision tran-sumbilical appendectomy is non-inferior to conventional laparoscopic appendectomy |
| Ethics approval(s) |
Approved 06/09/2021, Ministry of Health Standing Committee for the Coordination of Health and Medical Research in Kuwait (Ministry of Health Kuwait, Sulaibkhat - Jamal Abdel Nasser Street, Kuwait City, PO Box 5 zip code 13001, Kuwait; +965 (0)24878168; hsc.ethicalcommitee@ku.edu.kw), ref: 1793/2021 |
| Health condition(s) or problem(s) studied | Acute appendicitis |
| Intervention | Single incision transumbilical extracorporeal appendectomy. The patients were nonrandom and this novel technique was compared to conventional multiport laparoscopic appendectomy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The non-inferiority of the single incision extra-corporeal appendectomy (SIEA) in comparison to conventional three-port appendectomy (CA). This was measured by first taking the baseline characteristics of both groups in terms of: 1. Gender: male or female, in crude numbers, the two groups were compared using the chi-square analysis 2. Age: in crude numbers and the two groups were compared using the T-test analysis 3. Comorbidities: any patient with a comorbidity (diabetes type 1 and 2, hypertension, dyslipidemia, bronchial asthma, pregnancy, miscellaneous) is recorded, the total number of comorbidities present within the demographic would be summed up and the average number of comorbidities would be compared between the two groups as the number of comorbidities present using the chi-square analysis. 4. Symptoms the patients presented with (abdominal pain, nausea, vomiting, anorexia, fever, diarrhoea, constipation, dysuria) are recorded and calculated in a percentage format to assess the likelihood for symptoms to occur in both groups, calculate the alvorado score for each patient who presented with such symptoms, calculate the average in both groups and compare them using the T-test analysis. 5. Signs: white blood cell count as per the first two digits of the lab format (e.g. 12 instead of 12 x 10^9), the averages of both groups are compared using the T-test. Duration of symptoms in days, calculation of both averages achieved using the T-test, image positivity whether by ultrasound or CT image are recorded as either image positive or image negative, and the average occurrences in both groups are compared using the chi-square analysis. |
| Secondary outcome measures | 1. Cost analysis, derived from the cost of the disposable instruments as quoted by the companies that the ministries have contracted to provide for the surgery and calculated as an average cost between the two groups 2. Length of stay in days, recorded, averaged, and compared between both groups 3. Operative time in minutes, recorded, averaged and compared between both groups 4. Readmission rates: whether present or absent in each patient over 12 months, averaged and compared between both groups 5. Complications: stump leak, deep space infection, wound infection, wound dehiscence, reoperation over 12 months. Recorded as either present or absent, the rate of which would be added and the average of both groups compared using statistical tests depending on the variable (t-test, Fischer's exact test, etc) Noninferiority in this study would be defined as the absence of any increase in a negative variable in terms of complication rates, length of stay, cost, operative time of the study group (SIEA) compared to the control group (CA) while demonstrating no demographic difference between the two groups in terms of signs and symptoms. |
| Overall study start date | 01/10/2020 |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 156 |
| Key inclusion criteria | 1. Acute appendicitis 2. Able to sign a consent |
| Key exclusion criteria | Underage patients who are unable to provide consent |
| Date of first enrolment | 10/09/2021 |
| Date of final enrolment | 10/09/2022 |
Locations
Countries of recruitment
- Kuwait
Study participating centre
Kuwait City
47064
Kuwait
Sponsor information
Government
Sulaibkhat - Jamal Abdel Nasser Street, PO Box 5
Kuwait City
13001
Kuwait
| Phone | +965 (0)24878168 |
|---|---|
| appsupport@moh.gov.kw | |
| Website | https://www.moh.gov.kw/en/Pages/Default.aspx |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 28/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data aforementioned in this form will be made available after analysis in the journal article that is planned to be published. The raw data will be kept in a secure location by the investigators since it contains sensitive information pertaining to patient identity. |
Editorial Notes
08/01/2024: Study's existence confirmed by the Ministry of Health, Kuwait.
