This non-blind randomized clinical trial was conducted in Cairo University Specialized Children Hospital, Cairo- Egypt, and Suez Canal University Teaching Hospital, Ismailia- Egypt, from January 2019 to March 2021. Ethical and research committees approved the study as a part of Doctorate degree thesis. We included 152 participants in the study with unilateral and bilateral inguinal hernia and with no other major congenital anomalies. The study included patients from elective list with no history of recurrence or irreducibility who were randomized into two equal blocks each for one of the two techniques. Group A were operated using standardized technique of sac dissection and purse string suturing and group B were operated using sutureless repair. Sample size was calculated using https://clincalc.com/stats/samplesize.aspx.
After signing the informed consent from legal guardian, Patients were randomly assigned to either of the two groups using online randomization tool (http://www.randomization.com).
For groups, basic data and history was obtained including bilateralism, history of irreducibility, history of recurrence, and history of previous abdominal surgery. We performed ultrasound for ring size. We obtained a pre-operative ultrasound for all patients for which we measured the size of the ring size of the ring was included in comparing the outcomes of the two techniques.
Using general anesthesia, patient in supine 20degrees Trendlenberg position, 5mm port was inserted by Hasson technique infra-umbilical and pneumoperitoneum was achieved for a pressure range 8–10 mmHg according to patient age followed by introduction of 30 degree laparoscopy. Two instruments were introduced to the abdomen under vision on both sides of the rectus sheath without ports.
In both techniques the surgeon started dissection of the internal ring peritoneum above the vas and vessels, separating the peritoneum of the internal ring from the sac (Herniotomy). In group A (control group) we performed a purse string suture at the level of the internal ring peritoneum without any further dissection. In group B (Study Group) we performed a complete dissection and striping of the sac from the vas and vessels leaving at least 1cm of depritonization between the internal ring peritoneum and the remaining of the sac. Patient with bilateral inguinal hernia were operated with the same technique for both sides including patients with patent processus vaginalis found during surgery.
Our team afterward followed up patients for a period 6 months to record the data of recurrence or complications. All data were collected regarding intra-operative complications, early post-operative complications and recurrence. First visit was after one week of the surgery, subsequent visits were at 3 months, 6 months after surgery. Patients who needed follow up during COVID-19 outbreaks were contacted by phone to ask about any recurrent bulging in the inguinal region and were rescheduled for visits after the end of the governmental limitations.
The detailed data collected for analysis for each patient included the age, gender, side, size of the defect with pre-operative ultrasound examination, intraoperative time, and contralateral subclinical hernia discovered during the operation, intraoperative complications, early post-operative complications (scrotal edema, hematoma) and recurrence. Patients were then sub grouped according to ring size for further assessment of the recurrence factors.
Data were coded and entered using the statistical package for the Social Sciences (SPSS) version 25 (IBM Corp., Armonk, NY, USA). Data was summarized using mean, standard deviation, median, minimum and maximum in quantitative data and using frequency (count) and relative frequency (percentage) for categorical data. For comparing categorical data, Chi square test was performed. P-values less than 0.05 were considered as statistically significant.