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IRCT20181023041424N1 IRCT 2019-04-17 Iran University of Medical Sciences The benefits assessment of port-less laparoscopy in pediatric inguinal hernia repair The efficacy of port-less laparoscopic surgery in reducing costs and length of surgical scar in children with Inguinal hernia 2019-01-15 anticipated 68 Complete https://irct.ir/trial/36481 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We assign the children to portless (group B) and standard (group A). We have six possible combinations of group assignments regarding to size of block 4. All possible combinations were AABB, ABAB, BAAB, BABA, BBAA and ABBA. At the first, we select one of these arrangements at random and the four eligible admitted children were assigned accordingly in each block. We repeated this process many times to include the eligible children, Blinding description: Participants are categorized consciously in the intervention groups after being informed consent, but they are unaware of the allocation of the study group. The main investigator, who is the same surgeon and author of the article, is not blind and aware of the allocation of the groups, health care personnel (nurses, Etc.) who are responsible for the care of patients, are also unaware of the allocation of study groups, data collection authorities and those who evaluate the outcome, and the safety committee and data monitoring are unaware of the allocation of groups. N/A Pediatric inguinal hernia. Intervention 1: "Intervention group:" The intervention in the intervention group is to remove the umbilical port. After induction of general anesthesia, the Veress needle is first inserted into the abdominal cavity through the umbilical skin incision and the CO2 gas is injected with the appropriate volume and pressure, and after reaching the constant pressure, the needle is removed and the gas is cut off, then without the use of port the camera enters into the abdomen and the surgery continues. Intervention 2: "Control group:" After induction of general anesthesia, a 5 mm port is inserted in the umbilicus and the CO2 gas is continuously connected to the port and the gas is fed by the device. The appropriate lens is then inserted into the abdomen through the port and the surgical procedure is performed in a routine manner. (The control group received no intervention and was considered as a comparison group). Yes - There is a plan to make this available What will be shared: The whole potential data is publishable after being unidentifiable When: The beginning of the access period from the beginning of 1399 to 6 months after the publication of the results To whom: Only for researchers working in academic and scientific institutions Conditions: There are no specific requirements for sending requests for access to data or documentation Where to obtain: Tel number: 09381666138 Email Address:MK.surgeon@yahoo.com How to obtain: After receiving the application by email, the documents and data will be provided to the applicant at most within a week. Comments:
public Mohammad Karbalaei
No. 193, Dastgerdi Ave., Modares Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 2304 6253 karbalaei.m@iums.ac.ir Iran University of Medical Sciences scientific Mohammad Karbalaei
No. 193, Dastgerdi Ave., Modares Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 2304 6253 karbalaei.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) All patients with congenital inguinal hernia presented to the outpatient clinic 1 month 14 years Both Children who their parents declined to participate in this study Male infants less than 2 months old K40 Inguinal hernia Treatment - Surgery Treatment - Surgery "Intervention group:" The intervention in the intervention group is to remove the umbilical port. After induction of general anesthesia, the Veress needle is first inserted into the abdominal cavity through the umbilical skin incision and the CO2 gas is injected with the appropriate volume and pressure, and after reaching the constant pressure, the needle is removed and the gas is cut off, then without the use of port the camera enters into the abdomen and the surgery continues. "Control group:" After induction of general anesthesia, a 5 mm port is inserted in the umbilicus and the CO2 gas is continuously connected to the port and the gas is fed by the device. The appropriate lens is then inserted into the abdomen through the port and the surgical procedure is performed in a routine manner. (The control group received no intervention and was considered as a comparison group) Length of surgical scar. Timepoint: One month after the operation. Method of measurement: Ruler؛ Hospital Charts. Costs. Timepoint: At the time of discharge. Method of measurement: Hospital charts. Iran University of Medical Sciences Approved 2019-01-15 Ethics committee of Iran University of Medical Sciences Iran University of Medica Tehran Tehran Iran (Islamic Republic of)