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IRCT20180312039067N2 IRCT 2024-02-29 Esfahan University of Medical Sciences Evaluating the recurrence rate and adverse events of transversalis muscle fascia repair in total extraperitoneal repair (TEP) of inguinal hernia Evaluating the recurrence rate and adverse events of transversalis muscle fascia repair in total extraperitoneal repair (TEP) of inguinal hernia in Isfahan Al Zahra Hospital autom and winter of 1402: a double-blind clinical trial 2024-03-05 anticipated 60 Complete https://irct.ir/trial/74246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 patients with direct inguinal hernia who meet the inclusion criteria will be randomized in blocks based on unilateral or bilateral hernia with a one-to-one ratio by random allocation software 2.0 into two groups of laparoscopic repair with TEP method with or without inguinal canal repair, Blinding description: The main researcher of the study (surgeon) will provide the sealed code and the patient's information to another researcher who intends to follow up the patient in the mentioned time slots, who will not know about the patient's surgical method. 2-3 Inguinal hernia. Intervention 1: Control group: The inguinal canal will be repaired with the TEP method based on the published guidelines, and the mesh will be inserted without fixation. Intervention 2: Intervention group: In addition to the above cases, after the complete reduction of the direct hernia sac, the fascia of the transversalis muscle around the direct hernia will be closed with a 3-0 non-absorbable thread. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published When: The access period will start 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data. Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address vahidreisi@outlook.com or the contact number 09136043590 How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Pedram Hadipour
Number5, Mahan Convened, West aban alley, Kharazmi avenue, Sepahanshahr, Isfahan, Iran
Isfehan Iran (Islamic Republic of) 6816744111 +98 31 3651 8499 pmhr۶۸@gmail.com Esfahan University of Medical Sciences scientific Masoud Sayadi
Number5, Mahan convened, West aban alley, Kharazmi avenue, Sepahanshahr, Isfahan, Iran
Isfehan Iran (Islamic Republic of) 6816744111 +98 31 3651 8499 sayadi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) No history of abdominal surgery below the umbilical line Primary direct hernia or unilateral or bilateral recurrent hernia No history of mesh implantation BMI less than or equal to 40 No history of liver disorder characterized by ascites No history of renal failure failure to complete written consent 18 years no limit Both Need to repair inguinal hernia with open surgery Strangulated inguinal hernia K40 Inguinal hernia Treatment - Surgery Treatment - Surgery Control group: The inguinal canal will be repaired with the TEP method based on the published guidelines, and the mesh will be inserted without fixation. Intervention group: In addition to the above cases, after the complete reduction of the direct hernia sac, the fascia of the transversalis muscle around the direct hernia will be closed with a 3-0 non-absorbable thread. Operation time. Timepoint: First randomization day. Method of measurement: STOPWATCH. Hospitalization time. Timepoint: First randomization day. Method of measurement: Documentation in medical records. Recurrence. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Clinical exam. Pain. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Visual Analogue Scale (VAS) measures pain intensity. Seroma. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Ultrasonography. Infection. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: Clinical exam. Analgesics. Timepoint: Post operation 7th day, 1st, 3rd and 6th months. Method of measurement: History taking. Esfahan University of Medical Sciences Approved 2023-07-26 Ethics comitte of Isfahan university of Medical Sciences Hezar jarib street, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)