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IRCT20210224050491N1 IRCT 2021-03-08 Arak University of Medical Sciences Comparison of mesh fixation and non-fixation in laparoscopic inguinal hernia repair Comparison of mesh fixation and non-fixation in laparoscopic inguinal hernia repair 2021-03-21 anticipated 100 Complete https://irct.ir/trial/54612 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 100 patients who meet the inclusion criteria will be divided into two completely equal groups (50 people) using block randomization method and online software www.sealedenvelope.com and using 10 blocks of 10. . Concealment will be done using the sealed opaque envelope method. In this way, the created sequences will be placed in pots with dark cover and will be sealed, and in order to maintain a random sequence, the numbering on the outer surface of the envelopes will be done in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: This study will be double-blind. In this way, patients will be meshed in the operating room during anesthesia for both groups and patients will not be aware of the type of meshing performed. Also, the outcome assessor recognizes the study groups only on the basis of the letters A and B and is not aware of the intervention performed, and only the surgeon and the resident resident are aware of the study groups and the type of their intervention. N/A inguinal hernia. Intervention 1: Intervention group: After performing surgery for the patient in the final stage, after placing a fibrin mesh in the hernia site in the peritoneal wall, in addition to the two edges of the peritoneum will be sutured on the surgical site, the mesh itself will be sutured to the peritoneum. Intervention 2: Control group: In the control group, after surgery for the patient, in the final stage, a fibrin mesh will be placed at the hernia site in the peritoneal wall and two edges of the peritoneum will be bent on it at the surgical site, but the peritoneal mesh will not be sutured. 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 Ghasem Mehri
Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3417 3630 ghasemmehri1@gmail.com Arak University of Medical Sciences scientific Ghasem Mehri
Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3417 3630 ghasemmehri1@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Candidate patients for laparoscopic inguinal hernia repair surgery referred to Vali Asr Hospital in Arak 18 years 65 years Both History of kidney, liver and heart disease History of drug use Chronic use of painkillers K40 Inguinal hernia Treatment - Surgery Treatment - Surgery Intervention group: After performing surgery for the patient in the final stage, after placing a fibrin mesh in the hernia site in the peritoneal wall, in addition to the two edges of the peritoneum will be sutured on the surgical site, the mesh itself will be sutured to the peritoneum Control group: In the control group, after surgery for the patient, in the final stage, a fibrin mesh will be placed at the hernia site in the peritoneal wall and two edges of the peritoneum will be bent on it at the surgical site, but the peritoneal mesh will not be sutured. Recurrence of the disease. Timepoint: 1 month, 3 months and 6 months after intervention. Method of measurement: Physical examination. Pain. Timepoint: 1 hour, 6 hours and 24 hours after surgery. Method of measurement: Visual Analogue Scale of pain. Length of hospital stay. Timepoint: Time of discharge from the hospital. Method of measurement: Patient hospitalization file. Urinary retention. Timepoint: 1 hour, 6 hours and 24 hours after surgery. Method of measurement: Patient history. Arak University of Medical Sciences Approved 2021-01-24 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Sardasht Town Arak Markazi Iran (Islamic Republic of)