Comparison of Laparoscopic Appendectomy Vs Open Appendectomy concerning Early Surgical Site Infection Incidence, Single-Blinded Parallel-Group, Randomized Controlled Trial

To determine and compare early surgical site infection (SSI), intra-abdominal abscess rate, net cost, and postoperative quality of life between open and laparoscopic appendectomy.

Randomized, parallel group, single-blind (data analyst), phase 3 clinical trial in 2025 across all hospitals in Kerman; 162 patients, simple randomization using A/B card draw.

The trial will be conducted in 2025 across all hospitals in Kerman. Patients (Alvarado score >5) will be randomized into two groups. Only the data analyst will be blinded. Consent obtained, confidentiality maintained.

Patients aged 15–60 with uncomplicated acute appendicitis, no systemic disease or coagulation disorder, and signed informed consent will be included.

Both groups undergo appendectomy under general anesthesia by a unified surgical team. Group 1: Open surgery; Group 2: Three-port laparoscopic surgery. Closure and protocols are standardized.

Patients will be assessed on days 1, 2, 3, 7, and 14 after surgery for the occurrence of surgical site infection (SSI). The evaluated signs include redness at the incision site; purulent discharge; pain and swelling; fever; and culture results of the discharge in suspected cases. Additionally, the formation of intra-abdominal abscess will be evaluated using abdominal ultrasound. Other variables to be assessed include duration of surgery (minutes); length of hospital stay (days); consumption of opioid analgesics after surgery; and quality of life assessment during the first week post-surgery using the standardized WHO-QOL-BREF questionnaire.

Patients will be randomly assigned to either open or laparoscopic surgery using simple randomization. To this end, cards containing the letters A or B will be placed in identical envelopes, and one card will be randomly selected for each participant. If the letter A is drawn, the participant will be assigned to the open appendectomy group, and the next participant will be assigned to the laparoscopic appendectomy group. If the letter B is drawn, the participant will be assigned to the laparoscopic appendectomy group, and the next participant will be assigned to the open appendectomy group.

Patients will be blinded to the type of surgery (open/laparoscopic) only before the procedure, and blinding will not be possible after surgery. The surgeon cannot be blinded to the type of surgery. The individual analyzing the results will be blinded to patient allocation, and each surgical method will be assigned codes A and B for data analysis. Therefore, this study will be conducted as a single-blind trial (blinding only for the data analyst).

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