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IRCT20250507065635N1 IRCT 2025-10-01 Kerman University of Medical Sciences Laparoscopic vs. Open Appendectomy: Surgical Site Infection Study Comparison of Laparoscopic Appendectomy Vs Open Appendectomy concerning Early Surgical Site Infection Incidence, Single-Blinded Parallel-Group, Randomized Controlled Trial 2025-08-23 anticipated 162 Complete https://irct.ir/trial/83591 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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). N/A Acute appendicitis. Intervention 1: Control group: Open appendectomy (OA) performed under general anesthesia through a right lower quadrant abdominal incision using the standard open surgical technique. Skin closure is performed with appropriate sutures following routine protocols. Intervention group: Laparoscopic appendectomy (LA) performed under general anesthesia using a standard three-port laparoscopic technique for appendix dissection and removal. Skin closure is similarly done with sutures according to standard procedures. Both groups’ surgeries are conducted by the same surgical team following a unified protocol to minimize bias. Intervention 2: Intervention group: Laparoscopic appendectomy performed under general anesthesia using a standard three-port laparoscopic technique for appendix dissection and removal. The procedure follows established surgical guidelines and is conducted by a unified surgical team to minimize bias. Skin closure is done with appropriate sutures according to standard practice. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fatemeh Doost Mohammadi
Clinical Research Development Unit, Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran
kerman Iran (Islamic Republic of) 7613747181 +98 34 3244 1553 f.doostmohammadi2@gmail.com Kerman University of Medical Sciences scientific Fatemeh Doost Mohammadi
Clinical Research Development Unit, Shahid Bahonar Hospital, Kerman University of Medical Sciences, Kerman, Iran
kerman Iran (Islamic Republic of) 7613747181 +98 34 3244 1553 f.doostmohammadi2@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All patients with acute appendicitis and an Alvarado score greater than five will be included in the study. 10 years 65 years Both K35.80 Unspecified acute appendicitis Treatment - Surgery Treatment - Surgery Control group: Open appendectomy (OA) performed under general anesthesia through a right lower quadrant abdominal incision using the standard open surgical technique. Skin closure is performed with appropriate sutures following routine protocols. Intervention group: Laparoscopic appendectomy (LA) performed under general anesthesia using a standard three-port laparoscopic technique for appendix dissection and removal. Skin closure is similarly done with sutures according to standard procedures. Both groups’ surgeries are conducted by the same surgical team following a unified protocol to minimize bias. Intervention group: Laparoscopic appendectomy performed under general anesthesia using a standard three-port laparoscopic technique for appendix dissection and removal. The procedure follows established surgical guidelines and is conducted by a unified surgical team to minimize bias. Skin closure is done with appropriate sutures according to standard practice. Surgical site infection (SSI). Postoperative days 1, 2, 3, 4, 7, and 14 will be considered as the primary time points for outcome assessment. At these intervals, the surgical wound will be evaluated in terms of its appearance (e.g., potential discharge), blood tests (e.g., leukocyte count), and the presence of intra-abdominal abscesses using ultrasound imaging. Timepoint: Surgical site infection (SSI). Postoperative days 1, 2, 3, 4, 7, and 14 will be considered as the primary time points for outcome assessment. Method of measurement: The surgical wound will be evaluated in terms of its appearance (e.g., potential discharge), blood tests (e.g., leukocyte count), and the presence of intra-abdominal abscesses using ultrasound imaging. Surgery duration. Timepoint: By a digital clock by minute, and then entering it into a checklist. Method of measurement: Once during an appendectomy for each person. Postoperative pain score. Timepoint: For each person, 6, 2, 12, and 24 hours after the operation. Method of measurement: Visual Analog Scale. Frequency of use of housing until 48 hours after the operation. Timepoint: until 48 hours after the operation. Method of measurement: Using the patient record. Start consuming food. Timepoint: Recording the time of first intake of oral fluids, recording the time of starting a soft diet or light solid food, and recording the time of complete return to a normal diet after surgery. Method of measurement: Recording the time of first intake of oral fluids, recording the time of starting a soft diet or light solid food, and recording the time of complete return to a normal diet after surgery. Improve bowel movement. Timepoint: Recording the time of the first gas, recording the time of the first bowel movement, recording the time of hearing bowel sounds, and recording the time of food tolerance without nausea/vomiting. Method of measurement: Recording the time of the first gas, recording the time of the first bowel movement, recording the time of hearing bowel sounds, and recording the time of food tolerance without nausea/vomiting. Recovery of physical activity. Timepoint: Record the time when you do not need help to walk or go to the bathroom. Method of measurement: Record the time when you do not need help to walk or go to the bathroom. Length of hospital stay after surgery. Timepoint: Length of hospital stay after surgery. Method of measurement: Length of hospital stay by day and then recorded in the checklist. Changes in white blood cells and CRP levels after surgery. Timepoint: Twice: once 24 hours after surgery and once 5 days after surgery. Method of measurement: White blood cell count and C-reactive protein level. Postoperative quality of life. Timepoint: 7 days after surgery. Method of measurement: WHO-QOL-BREF standard questionnaire. Kerman University of Medical Sciences Approved 2025-09-27 Afzalipour Hospital-Kerman University of Medical Sciences Medical University Campus, Haft-Bagh Highway, Kerman, Iran kerman Kerman Iran (Islamic Republic of)