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IRCT20210309050650N2 IRCT 2021-11-06 Zanjan University of Medical Sciences Comparison of mesh fixation and non-fixation in laparoscopic Transabdominal prepritoneal inguinal hernia repair Comparison of outcomes and complications of mesh fixation and non-fixation in laparoscopic Transabdominal prepritoneal inguinal hernia repair in patients with primary inguinal hernia 2021-11-01 anticipated 112 Complete https://irct.ir/trial/59787 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomized block is used to randomize the patients under study and to fully observe the randomness of placement in the control group and the sample group because the inclusion process requires randomization due to the ongoing recruitment. Based on the calculated sample size, the sample size in each group is 24 people for easier application of random blocks to randomize the members of each group. Permutations are considered as 6 permutations according to 2 groups: AABB, ABAB, BBAA, BABA, BAAB, ABBA. The permutations are written on 6 cards and the selection of permutations and their order will be randomly selected from among the cards. The order of exit of the cards is written and will determine the order of recruitment of intervention groups based on it. An individual randomization unit will be used for the study. The information of the registered persons will be anonymous and without their personal information. N/A Primary inguinal hernia. Intervention 1: Intervention group: In this group, the peritoneum is first cut on the middle umbilical ligament so that this incision is 3-4 cm above the hernia defect and extends laterally to the upper anterior iliac spine. After removal and ligation of the sac hernia, the mesh used is usually 10 x 15 so that it can completely cover the myopectineal hole. After fixing the 3D mesh, the mesh will not be fixed. The arched position of the mesh will allow the mesh to fit properly. Finally, the peritoneum is completely closed to prevent the intestines from hitting the mesh. Intervention 2: Control group: In this group, the peritoneum is first cut on the middle umbilical ligament so that this incision is 3-4 cm above the hernia defect and extends laterally to the upper anterior iliac spine. After removal and ligation of the sac hernia, the mesh used is usually 10 x 15 so that it can completely cover the myopectineal hole. After placing the 3D mesh, the mesh will be fixed to the Cooper ligament with the help of a spiral tucker. Finally, the peritoneum is completely closed to prevent the intestines from hitting the mesh. The number of Tackers required to do this will vary in patients. 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 Its release schedule is not yet known.
public Naser Keikhali
Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 nkeikhali@zums.ac.ir Zanjan University of Medical Sciences scientific Naser Keikhali
Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 nkeikhali@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with primary inguinal hernia 18 years no limit Both Age under 18 years Dementia and other psychological disorders Impossibility of proper follow-up of the patient Contraindications to general anesthesia Contraindications Laparoscopic surgery Bilateral inguinal Hernia The hernia has recurred History of previous abdominal surgery and intra-abdominal adhesions drug abuse Taking psychiatric drugs Liver and kidney diseases K40.90 Unilateral inguinal hernia, without obstruction or gangrene, not specified as recurrent Treatment - Surgery Treatment - Surgery Intervention group: In this group, the peritoneum is first cut on the middle umbilical ligament so that this incision is 3-4 cm above the hernia defect and extends laterally to the upper anterior iliac spine. After removal and ligation of the sac hernia, the mesh used is usually 10 x 15 so that it can completely cover the myopectineal hole. After fixing the 3D mesh, the mesh will not be fixed. The arched position of the mesh will allow the mesh to fit properly. Finally, the peritoneum is completely closed to prevent the intestines from hitting the mesh. Control group: In this group, the peritoneum is first cut on the middle umbilical ligament so that this incision is 3-4 cm above the hernia defect and extends laterally to the upper anterior iliac spine. After removal and ligation of the sac hernia, the mesh used is usually 10 x 15 so that it can completely cover the myopectineal hole. After placing the 3D mesh, the mesh will be fixed to the Cooper ligament with the help of a spiral tucker. Finally, the peritoneum is completely closed to prevent the intestines from hitting the mesh. The number of Tackers required to do this will vary in patients. Postoperative pain in patients. Timepoint: Patients' pain will be assessed on days 2, 7 and the third and sixth months after surgery. Method of measurement: Based on Visual Analogue Scale scale, data would be collected. Zanjan University of Medical Sciences Approved 2021-10-26 Ethics committee of Zanjan University of Medical Sciences Ayatollah Mousavi Hospital Zanjan Zanjan Iran (Islamic Republic of)