The efficacy of port-less laparoscopic surgery in reducing costs and length of surgical scar in children with Inguinal hernia

Assessment of the feasibility, safety and potential benefits of laparoscopic repair for congenital inguinal hernia (CIH) in our hospital using portless technique.

Clinical trial with control group, parallel, one blinded, randomized

Feasibility of portless laparoscopic repair of the inguinal hernia, conversion rate and need for umbilical port were the main measurements. The data collection tool included a questionnaire with two parts and a checklist of items. All patients were examined after one week, then at 3 and 6 months. This study was conducted at Ali Asghar children`s hospital, Tehran,Iran. The study was conducted one-blinded, so patients and surgical nurses were unaware of how the study groups were assigned.

68 patients with congenital inguinal hernia (CIH) presented to the outpatient clinic and were eligible to be enrolled. Boys under 2 months old for fear of damage to cord structures and children who their parents declined to participate in this study were excluded.

In the 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. Camera is then inserted through the port and the surgical procedure is performed in a standard manner. In the non-port (intervention) group, after induction of general anesthesia, the Veress needle is first inserted into the abdominal cavity through a small 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 without the use of port (the main intervention is the removal of the port), the camera enters into the abdomen and the surgery continues according to the routine.

Length of surgical scar ؛ Costs

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

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.

The whole potential data is publishable after being unidentifiable

The beginning of the access period from the beginning of 1399 to 6 months after the publication of the results

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