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IRCT20200825048515N25 IRCT 2021-03-17 Esfahan University of Medical Sciences Comparison of the effect of fix and non-fix mesh (Use of external fixation (hernia band) after surgery) in causing complications after hernioplasty surgery Comparative study of the effect of fixation mesh and non-fixation of mesh (Use of external fixation (hernia band) after surgery) in causing postoperative complications in patients with inguinal hernia undergoing laparoscopic hernioplasty 2021-02-07 anticipated 64 Complete https://irct.ir/trial/53941 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 64 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: Due to the nature of the present study, the surgeon is aware of the type of surgery in each of the two groups, but the patient and the evaluator (data collector) are not aware of the type of surgery in each group. 3 Inguinal hernia. Intervention 1: Control group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh(Bard 3D Max) is fixed internally (using Vicryl suture 2-0). Intervention 2: Intervention group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh is not fixed and after the operation, an external hernia(Paksaman) is used. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Masoud Sayadi Shahraki
Al-Zahra Hospital, Department of Surgery
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 sayadi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Masoud Sayadi Shahraki
Al-Zahra Hospital, Department of Surgery
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 sayadi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Having an inguinal hernia Satisfaction with participation in this study no limit no limit Both Having an incarcerated hernia Having a strangulated hernia Having a very large inguinal hernia (scrotal) Having a femoral inguinal hernia K40.3 Unilateral inguinal hernia, with obstruction, without gangrene Treatment - Surgery Treatment - Other Control group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh(Bard 3D Max) is fixed internally (using Vicryl suture 2-0). Intervention group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh is not fixed and after the operation, an external hernia(Paksaman) is used. Seroma. Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Observation. Hematoma. Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Observation. Pain. Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Visual Analogue Scale (VAS). Recurrence of hernia. Timepoint: 1, 3 and 6 months after surgery. Method of measurement: Observation. Isfahan University of Medical Sciences Approved 2020-12-13 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)