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IRCT20161217031440N3 IRCT 2021-10-14 Shahid Beheshti University of Medical Sciences Comparison of recurrence rate and pain severity in patients with incisional hernia in open and laparoscopic methods Comparison of recurrence rate and pain severity in patients with incisional hernia in open and laparoscopic methods 2021-10-17 anticipated 70 Complete https://irct.ir/trial/59270 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are randomly assigned into two groups (open and laparoscopic) using a random number table. A random number table containing unrepeated numbers between 1 and 70 is selected and the reading is started from the left. If the number is odd the patient is assigned into open group and if the number is even the patient is assigned into laparoscopic group, Blinding description: The person evaluating the patients is not aware of patients assignment and so is blinded. 2-3 Incisional hernia. Intervention 1: Intervention group 1: surgery using open method. Intervention 2: Intervention group 2: surgery using laparoscopic method. 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 There is no more information.
public Barmak Gholizadeh
Shahid Modarres hospital, Saadat abad
Tehran Iran (Islamic Republic of) 193954719 +98 21 2298 6403 b_gholizadeh@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Barmak Gholizadeh
Shahid Modarres hospital, Saadat Abad st.
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2208 3109 barmak.gholizadeh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having incisional hernia with a 3-15 cm diameter 18 years 80 years Both Having contraindication for anesthesia Having immunosuppression Having intestinal obstruction K43.0 Incisional hernia with obstruction, without gangrene Treatment - Surgery Treatment - Surgery Intervention group 1: surgery using open method Intervention group 2: surgery using laparoscopic method Recurrence rate. Timepoint: One year after the surgery. Method of measurement: By asking the patient about the recurrence. Pain severity. Timepoint: 3 days, one week and 4 weeks after the surgery. Method of measurement: By using Visual Analogue Scale. Shahid Beheshti University of Medical Sciences Approved 2020-12-15 Ethics committee of Shahid Beheshti University of Medical Sciences Third Floor, School of Medicine, Aarabi st., Yaman st., Shahid Chamran hwy. Tehran Tehran Iran (Islamic Republic of)