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IRCT20231029059895N1 IRCT 2025-03-14 Esfahan University of Medical Sciences The Enhanced View-Totally Extra-peritoneal (eTEP) Technique for Repair of Inguinal Hernia after Radical Prostatectomy The Enhanced View-Totally Extra-peritoneal (eTEP) Technique for Repair of Inguinal Hernia after Radical Prostatectomy: A Clinical Trial 2025-01-04 anticipated 60 Complete https://irct.ir/trial/80566 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Inguinal Hernia. Intervention 1: Intervention group: The patients in this group are operated with the eTEP technique, which is described as follows: A transverse incision is performed superior to the umbilicus, utilizing a transrectal approach on the left side. The posterior sheath of the rectus abdominis muscle is meticulously separated to gain access to the preperitoneal space. The carbon dioxide gas source is calibrated to achieve an intra-abdominal pressure (IAP) of 12 mmHg. Following this, a 10 mm optic trocar is introduced. The hernia sac is transferred into the preperitoneal space and repositioned laterally. The pubic bone and the inguinal ligament are subsequently isolated. A 12 × 15 cm mesh is secured in place using a stapler. The preperitoneal space is then evacuated, and the surgical wounds are sutured closed, followed by bandaging. Intervention 2: Control group: Patients in this group are operated on with the TAPP technique. In Transabdominal Preperitoneal (TAPP) repair for inguinal hernia, the procedure begins with the patient under general anesthesia in a supine Trendelenburg position. A 10 mm infraumbilical trocar is inserted for the laparoscope, with two additional 5 mm working ports placed in the lower abdomen. A peritoneal incision is made above the hernia defect, and the peritoneal flap is dissected to expose the preperitoneal space. The hernia sac is carefully reduced, with indirect sacs fully dissected and direct sacs reduced. A synthetic mesh (typically 10x15 cm) is then placed in the preperitoneal space, covering the myopectineal orifice, and secured with tacks or fibrin glue if necessary. The peritoneal flap is closed using sutures or tacks to prevent mesh exposure to the bowel. Finally, trocar sites are closed, and the patient is awakened from anesthesia and monitored postoperatively for early complications. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information is available.
public Masoud Sayyadi Shahraki
Sofe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 0000 drsayadi@yahoo.com Esfahan University of Medical Sciences scientific Alireza Jalili
Sofe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 0000 jalili.alireza110@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inguinal Hernia diagnosis with a history of radical prostatectomy 18 years no limit Male Patients eligibility to be laparscopic inguinal hernia repair surgery candidates. K40 inguinal hernia Treatment - Surgery Treatment - Surgery Intervention group: The patients in this group are operated with the eTEP technique, which is described as follows: A transverse incision is performed superior to the umbilicus, utilizing a transrectal approach on the left side. The posterior sheath of the rectus abdominis muscle is meticulously separated to gain access to the preperitoneal space. The carbon dioxide gas source is calibrated to achieve an intra-abdominal pressure (IAP) of 12 mmHg. Following this, a 10 mm optic trocar is introduced. The hernia sac is transferred into the preperitoneal space and repositioned laterally. The pubic bone and the inguinal ligament are subsequently isolated. A 12 × 15 cm mesh is secured in place using a stapler. The preperitoneal space is then evacuated, and the surgical wounds are sutured closed, followed by bandaging. Control group: Patients in this group are operated on with the TAPP technique. In Transabdominal Preperitoneal (TAPP) repair for inguinal hernia, the procedure begins with the patient under general anesthesia in a supine Trendelenburg position. A 10 mm infraumbilical trocar is inserted for the laparoscope, with two additional 5 mm working ports placed in the lower abdomen. A peritoneal incision is made above the hernia defect, and the peritoneal flap is dissected to expose the preperitoneal space. The hernia sac is carefully reduced, with indirect sacs fully dissected and direct sacs reduced. A synthetic mesh (typically 10x15 cm) is then placed in the preperitoneal space, covering the myopectineal orifice, and secured with tacks or fibrin glue if necessary. The peritoneal flap is closed using sutures or tacks to prevent mesh exposure to the bowel. Finally, trocar sites are closed, and the patient is awakened from anesthesia and monitored postoperatively for early complications. Grade of pain. Timepoint: 2 hours, 1 day, at discharge, one month after surgery. Method of measurement: Visual Analogue Scale. Complications (Hematoma, seroma, Rehospitalization, Hernia recurrence), Vascular, bladder or, bowels injury. Timepoint: During or after surgery. Method of measurement: Surgeon's evaluations and reports. Esfahan University of Medical Sciences Approved 2025-02-08 Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib St., Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)