Acute appendicitis Digestive System Acute appendicitis
Conditions
Interventions
Single incision transumbilical extracorporeal appendectomy. The patients were nonrandom and this novel technique was compared to conventional multiport laparoscopic appendectomy.
Sponsors
Kuwait Ministry of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute appendicitis 2. Able to sign a consent
Exclusion criteria
Exclusion criteria: Underage patients who are unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Kuwait
Contacts
Public ContactSalman Alsafran
Outcome results
None listed