]>
IRCT20200727048228N1 IRCT 2020-09-05 Shahid Beheshti University of Medical Sciences Comparison of Inguinal Hernia Repair with Laparoscopic and open Methods Comparison of Early Complications and Recurrence in Inguinal Hernia Surgery with Laparoscopic (TAPP) and Open Methods (Lichtenstein) 2018-08-25 anticipated 84 Complete https://irct.ir/trial/49916 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: As most laparoscopic surgeries are performed under general anesthesia, in order to make both study arms equal, both arms will undergo operation with spinal anesthesia, Randomization description: Permuted Block Randomization, Block Size of 2 An 84 row random sequence was produced by R software, then patients who consent to either type of surgery where registered into the aforementioned sequence according to the order of referral and patient's surgery type was determined. N/A Inguinal Hernia. Intervention 1: Intervention group: Trans Abdominal PrePeritoneal Laparoscopic Surgery with Spinal Anesthesia (standard 3 port surgery with transabdominal peritoneal dissection and fixation of mesh in preperitoneal space. Intervention 2: Control group: Lichtenstein Open Surgery with Spinal Anesthesia with standard inguinal incision, incising external oblique fascia, skeletonizing cord, resection of hernia sac and fixation of mesh. Yes - There is a plan to make this available What will be shared: Information about the main outcome may be shared When: Accessible after publication of the trial To whom: Researchers and employees in academic and scientific institutions Conditions: Use of data to complete their studies Where to obtain: Dr. Mansour Nateghi How to obtain: Data can be shared after reviewing the researcher's request and provision of sufficient documentation of his/her research and the reason for using the data Comments:
public Mansour Nateghi
Imam Hussein Hospital, Madani St, Nezam-Abad
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 mansournateghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Behzad Nemati Honar
Imam Hussein Hospital, Madani St, Nezam-Abad
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 behzadnematihonar@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Consent of the Patients Unilateral Non-Incarcerated Primary Inguinal Hernia (Non-Recurrent) 18 years no limit Both Patient Dissent Recurrent Hernia Bilateral Hernia Patients with Underlying Diseases (e.g; Asthma, Benign prostatic hyperplasia, Chronic obstructive pulmonary disease) Heavy Workers K40.90 Unilateral inguinal hernia, without obstruction or gangrene, not specified as recurrent Treatment - Surgery Treatment - Surgery Intervention group: Trans Abdominal PrePeritoneal Laparoscopic Surgery with Spinal Anesthesia (standard 3 port surgery with transabdominal peritoneal dissection and fixation of mesh in preperitoneal space Control group: Lichtenstein Open Surgery with Spinal Anesthesia with standard inguinal incision, incising external oblique fascia, skeletonizing cord, resection of hernia sac and fixation of mesh Severity of Post-op Pain. Timepoint: Just After Surgery, 8h, 24h, 48h and a week after the operation. Method of measurement: Visual Analogue Scale. Surgical Site Infection. Timepoint: 2 and 7 days after surgery. Method of measurement: Physical Examination. Seroma. Timepoint: 2 and 7 days after surgery. Method of measurement: Physical Examination. Hematoma. Timepoint: 2 and 7 days after surgery. Method of measurement: Physical Examination. Recurrence. Timepoint: 6 months and a year after surgery. Method of measurement: Physical Examination. Research Chancel of Shahid Beheshti University of Medical Sciences Approved 2018-07-10 Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Arabi St., Yaman St., Chamran Highway Tehran Tehran Iran (Islamic Republic of)