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

The aim of this study is to evaluate direct repair of hernia defects with sutures, with the aim of reducing seroma formation and recurrence after direct laparoscopic inguinal hernia repair.

60 patients with direct inguinal hernia who meet the inclusion criteria, will be randomized in blocks based on whether the hernia is unilateral or bilateral with a one-to-one ratio by random allocation software to two groups of laparoscopic repair with TEP with or without repair of the inguinal canal with non-absorbable sutures.

The hernia will be repaired and then the main researcher of the study (surgeon) will provide the code and the patient's information to another researcher who intends to follow up the patient in the mentioned time intervals, who will not know the patients' surgical procedure.

Age older than 18 years, no history of open abdominal surgery, primary direct hernia or unilateral or bilateral recurrent hernia, no history of mesh implantation, BMI less than or equal to 40, and exclusion criteria: history of liver disorder characterized by ascites, failure kidney, failure to complete written consent, need to repair inguinal hernia with open surgery, history of abdominal surgery below the umbilical line Exclusion criteria: strangulated inguinal hernia

Inguinal canal will be repair with the TEP method and the mesh will be inserted without fixation. In the 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.

The rate of surgical complications, including seroma, recurrence, surgical infection, acute pain, chronic pain, and other possible complications and patient safety

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.

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.

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

The access period will start 6 months after the results are published

The data will be available to researchers working in academic and scientific institutions.

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.

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

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.