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IRCT20200114046127N1 IRCT 2020-02-20 Esfahan University of Medical Sciences Postoperative Chronic Pain and Quality of Life following Laparoscopic Trans-Abdominal Preperitoneal (TAPP) Inguinal Hernia Surgery Randomised Clinical Trial on Postoperative Chronic Pain and Quality of Life following Laparoscopic Trans-Abdominal Preperitoneal (TAPP) Inguinal Hernia Surgery; a Comparison between Mesh Fixation Methods of Tacks, Vicryl Suture, and Non-fixation 2017-04-21 anticipated 189 Complete https://irct.ir/trial/45017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In addition to the effective treatment of the medical condition subjected to the study, this trial attempts to improve the patients' quality of life and to reduce surgical complications, Randomization description: Simple randomisation by using the table of random numbers, Blinding description: Patients, investigators, and data analyst did not have any knowledge of the patient's assigned study group. N/A Condition 1: Unilateral Inguinal hernia. Condition 2: Bilateral Inguinal hernia. Condition 3: Chronic pain after herniotomy. Intervention 1: Control group: Patients undergo general anaesthesia and surgery is performed in Trendelenburg position. Thirty minutes before surgery, one gram of cefazoline is injected intravenously. CO2 Insufflation is performed via an open technique of umbilical 11 mm port insertion. In unilateral repair, two 5 mm ports are installed in midclavicular lines. Insertion point on the ipsilateral side is 2 inches above and on the contralateral side 2 inches below the umbilical line. In bilateral repair, both 5 mm ports are located on the umbilical line. Peritoneal dissection is started at the inferior epigastric vessels site and extended medially to umbilical vessels fold and laterally to ASIS with a maximum size of 13 cm. In the case of direct hernia, the hernia sac is dissected and reduced. In indirect or femoral hernias, Para pubic preperitoneal fat pad is dissected to visualise pubic ramus and cooper ligament. Retrovesical preperitoneal dissection allows for better and easier mesh covering. Internal ring is explored and sac is dissected. After dissection of the spermatic cord from parietal peritoneum, a monofilament propylene 10x15 cm mesh is inserted and embedded in the preperitoneal space. This kind of mesh allows visualisation of underlying tissues. Medially mesh is in contact with paravesical space and laterally with ASIS. In the first group, the mesh is fixed to the inguinal ligament and pubic tubercle with 3-4 tacks. The last step is reperitonealization over the mesh and peritoneal repair. Intervention 2: First intervention group: In the second group, the mesh is spread in the same space, but in the next step, the mesh is fixed with a 2-0 Vickryl suture to a point over the internal ring. Other steps of the operation are carried out the same as the control group. Intervention 3: Second intervention group: In the third group, the exact surgical technique as the control group is applied, except that after mesh placement, fixation is not performed. 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 There is no more information currently. Data will be updated.
public Dr. Sara Aghaei
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶ +98 31 3668 0048 saraaghaei.nsr@gmail.com Esfahan University of Medical Sciences scientific Dr. Behrooz Kleidari
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱-۸۱۷۴۶ +98 31 3668 0048 alagol83@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18, with the diagnosis of uncomplicated primary uni/bilateral reducible inguinal or femoral hernia; Eligible for elective laparoscopic hernia repair and general anaesthesia, ASA (American Society of Anesthesiologists) score of ≤ 3. 18 years no limit Both Patients with complicated, incarcerated, strangulated, or recurrent hernia; Following medical conditions: coagulopathy, immunosuppression, current anticoagulation treatment, current opioid or alcohol substance abuse, ongoing long term treatment with steroids and analgesics, ASA score > 3, and BMI ≥ 35. K40.90 K40.20 G89.28 Unilateral inguinal hernia, without obstruction or gangrene, not specified as recurrent Bilateral inguinal hernia, without obstruction or gangrene, not specified as recurrent Other chronic postprocedural pain Treatment - Surgery Treatment - Surgery Treatment - Surgery Control group: Patients undergo general anaesthesia and surgery is performed in Trendelenburg position. Thirty minutes before surgery, one gram of cefazoline is injected intravenously. CO2 Insufflation is performed via an open technique of umbilical 11 mm port insertion. In unilateral repair, two 5 mm ports are installed in midclavicular lines. Insertion point on the ipsilateral side is 2 inches above and on the contralateral side 2 inches below the umbilical line. In bilateral repair, both 5 mm ports are located on the umbilical line. Peritoneal dissection is started at the inferior epigastric vessels site and extended medially to umbilical vessels fold and laterally to ASIS with a maximum size of 13 cm. In the case of direct hernia, the hernia sac is dissected and reduced. In indirect or femoral hernias, Para pubic preperitoneal fat pad is dissected to visualise pubic ramus and cooper ligament. Retrovesical preperitoneal dissection allows for better and easier mesh covering. Internal ring is explored and sac is dissected. After dissection of the spermatic cord from parietal peritoneum, a monofilament propylene 10x15 cm mesh is inserted and embedded in the preperitoneal space. This kind of mesh allows visualisation of underlying tissues. Medially mesh is in contact with paravesical space and laterally with ASIS. In the first group, the mesh is fixed to the inguinal ligament and pubic tubercle with 3-4 tacks. The last step is reperitonealization over the mesh and peritoneal repair. First intervention group: In the second group, the mesh is spread in the same space, but in the next step, the mesh is fixed with a 2-0 Vickryl suture to a point over the internal ring. Other steps of the operation are carried out the same as the control group. Second intervention group: In the third group, the exact surgical technique as the control group is applied, except that after mesh placement, fixation is not performed. Chronic post-herniorrhaphy inguinal pain. Timepoint: 3, 6, and 12 months after surgery. Method of measurement: 100 mm Visual Analogue Scale for assessment of pain intensity. Post-herniorrhaphy quality of life. Timepoint: 12 months after surgery. Method of measurement: The Medical Outcome Survey SF-36 questionnaire for quality of life evaluation. Acute postoperative inguinal pain. Timepoint: 1 and 10 days after surgery. Method of measurement: 100 mm Visual Analogue Scale for assessment of pain intensity. Intraoperative complications. Timepoint: During surgery. Method of measurement: Intraoperative assessments by the surgeon. Postoperative complications including surgical site infection, seroma and hematoma formation, orchitis, and neuralgia. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient; physical examination. Duration of surgery. Timepoint: During surgery. Method of measurement: Timer. Length of hospital stay. Timepoint: In the first week after surgery. Method of measurement: Recording duration of hospitalization. Duration of analgesic use for the management of postoperative groin pain. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient. Time of return to normal daily activities. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient. Recurrence of hernia. Timepoint: 1 and 10 days, 3, 6, and 12 months after surgery. Method of measurement: Interview with the patient; physical examination. Esfahan University of Medical Sciences Approved 2018-01-02 Research Ethics Committee of Isfahan University of Medical Sciences and Health Services Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)