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IRCT20140310016917N10 IRCT 2024-06-11 Rasht University of Medical Sciences Comparison of the Clinical Outcomes of Laparoscopic Inguinal Hernia Surgery using the Preperitoneal Intra-Abdominal TAPP Method with and without Septal Defect Closure in Patients with Inguinal Hernia: A Randomized Controlled Clinical Trial Comparison of the Clinical Outcomes of Laparoscopic Inguinal Hernia Surgery using the Preperitoneal Intra-Abdominal TAPP Method with and without Septal Defect Closure in Patients with Inguinal Hernia: A Randomized Controlled Clinical Trial 2024-07-22 anticipated 76 Complete https://irct.ir/trial/77046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done from the website https://www.sealedenvelope.com. The randomization of this study will be by the blocked randomization method. Based on the list obtained from this website, each person will be randomly assigned to the control or intervention group using 4 random blocks with the number of 19 blocks in a ratio of 1:1. Using this method, each person is assigned one of the letters A or B to each group, and for randomization, the list of codes obtained from this website will be provided to the project researchers, and every patient with inguinal hernia who meets the conditions for entering the study , will be entered into the plan according to the assigned code, Blinding description: In this study, patients undergoing surgery will be unaware of which surgical procedure they will undergo, and the outcome assessor will also be unaware of which patient will undergo which procedure. N/A Hernia. Intervention 1: Intervention group: Transabdominal laparoscopic preperitoneal surgery method without defect closure. Intervention 2: Control group:Transabdominal laparoscopic preperitoneal surgery method with defect closure. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "No more information"
public Moein Moghadam Ahmadi
Poursina Hospital, Parastar St.
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3232 3971 crdu_poursina@gums.ac.ir Rasht University of Medical Sciences scientific Moein Moghadam Ahmadi
Poursina Hospital, Parastar St.
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3232 3971 crdu_poursina@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Unilateral or Bilateral Hernia American Society of Anesthesiologists Risk score (ASA class 1 or 2) 18 years no limit Both Symptoms of Peritonitis Previous Major Abdominal and Pelvic Surgery Contraindication General Anesthesia or laparoscopy Incarcerated Hernia Strangulated Hernia K40.9 Unilateral inguinal hernia, without obstruction or gangrene Treatment - Surgery Treatment - Surgery Intervention group: Transabdominal laparoscopic preperitoneal surgery method without defect closure Control group:Transabdominal laparoscopic preperitoneal surgery method with defect closure Occurrence of complication of Hematoma. Timepoint: 24 hours after the surgery. Method of measurement: Clinical examination. Occurrence of complication of surgery site infection. Timepoint: One month after surgery. Method of measurement: Clinical examination. Occurrence of complication of Seroma. Timepoint: One month to 6 months after surgery. Method of measurement: Clinical examination and ultrasound. Acute postoperative pain. Timepoint: 24 hours after the surgery. Method of measurement: Visual Analogue Scale. Chronic pain after surgery. Timepoint: 6 months after surgery. Method of measurement: Visual Analogue Scale. Returning to normal activities. Timepoint: 6 months after surgery. Method of measurement: Patient interview. Hernia recurrence. Timepoint: 6 months after surgery. Method of measurement: Physical examination. Rasht University of Medical Sciences Approved 2024-04-24 Research Ethics Committees of Guilan university of medical sciences University Research and Technology Vice-Chancellor, Shahid Siyadati St., Namjo St. Rasht Guilan Iran (Islamic Republic of)