The goal of this clinical trial is to learn if hernia sac transection works to treat pediatric inguinal hernia. Researchers will compare hernia sac transection to hernia sac reduction (traditional inguinal hernia repair) to see outcome in 6 months. Visit the clinic at week1, month3, month 6 for follow-up.
An inguinal hernia is a common condition in children where abdominal contents push through a weak spot in the abdominal wall into the groin area. Normally, when the testicles move from the abdomen into the scrotum, the peritoneal lining is pulled downward with them through the inguinal canal. The testicles are fully descended into the scrotum at about eighth months of gestation. Afterward, the opening created by this pouch closes and dissolves. The persistence of this inguinal canal, which should have closed spontaneously, is a common cause of hernias in children, with an incidence of 3.5-5% and it increases up to 44-55% in premature infants. Inguinal hernias often require surgical repair due to the risk of complications like bowel obstruction, which occurs in a significant percentage of cases with an incidence of 3-16%. Open surgery remains the most common method for inguinal hernias. A study by Chukwubuike KE et al. found that pediatric inguinal hernia repair had a postoperative complication rate of 9.9%. The most common complications were scrotal edema, scrotal hematoma, wound infection, hernia recurrence, testicular atrophy และsensory disturbance in the groin region. Laparoscopic hernia surgery has become more widely used since the first operation in 1993. In this procedure, the hernia sac is cut open and the patent processus vaginalis is used to tighten the internal inguinal ring to prevent future hernias. The purse-string technique is used to close the opening of the internal ring without removing the hernia sac. Laparoscopic surgery offers faster recovery and less risk of spermatic cord injury, with similar operative times and shorter hospital stays compared to open surgery. However, it requires a higher initial cost and the expertise of a surgeon experienced in the procedure. In a study by Kelly Dreuning, Laparoscopic versus open pediatric inguinal hernia repair: state of the art comparison and future perspectives from a meta-analysis, laparoscopic and open hernia repairs were performed in 375 and 358 patients, respectively. There was no difference in recurrence between the two groups. Open hernia repair is still used for pediatric patients at Ramathibodi Hospital in order to remove the hernia sac from the spermatic cord. It is a complicated procedure, especially when dealing with big hernias. In a study by Roberto Cirocchi et al., Comparison of hernia sac transection and full sac reduction for the treatment of inguinal hernia: A systematic review and meta-analysis of clinical trials, 1,824 patients were included in the systematic review and meta-analysis of clinical trials which comprised 12 randomized controlled trials (RCTs) and 3 controlled clinical trials (CCTs). Nine hundred and thirty-five of these 1,824 patients had hernia sac transection, and nine hundred and sixty-six had hernia sac reduction. The study found that the two techniques were similar in terms of primary and secondary outcomes, even though hernia sac reduction might lead to a lower, albeit not statistically significant, recurrence rate. The study by Mohamed Ali Chaouch et al., A systematic review and meta-analysis of hernia sac management in laparoscopic groin hernia mesh repair: reduction or transection, is a systematic review and meta-analysis (PRISMA) study which included 6 studies with a total of 2,941 patients: 821 in the transection group and 2,120 in the reduction group. It was found that the transection group had a significantly lower rate of postoperative seroma than the reduction group (OR = 1.71; 95% CI \[1.22, 2.39\], p = 0.002). However, there was no significant difference between the two groups in operative time (MD = -4.39; 95%CI \[-13.62, 4.84\], p = 0.35) and recurrence rate (OR = 2.70; 95%CI \[0.50,14.50\], p = 0.25) The aforementioned information indicates that research has been done on the rates of complications following hernia surgery involving the excision of the hernia sac by reduction and transection. However, as of now, there are no conclusive findings about laparoscopic surgery. Thus, this study aimed to assess the rates of complications in pediatric patients who underwent open hernia surgery using reduction and transection techniques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
After administering anesthesia, a standard open inguinal hernia surgery typically was performed by the surgeon. Open inguinal hernia surgery using hernia sac transection technique. Other practices for the patient were as per standard care, including examination, diagnosis, treatment and follow-up.
After administering anesthesia, a standard open inguinal hernia surgery typically was performed by the surgeon. Open inguinal hernia surgery using hernia sac reduction technique. Other practices for the patient were as per standard care, including examination, diagnosis, treatment and follow-up.
Ramathibodi hospital
Ratchathewi, Bangkok, Thailand
RECRUITINGReactive hydrocele
Number of Participants with diagnosed through a physical examination that includes a transillumination test, where a soft, fluid-filled mass in the scrotum will glow with a soft, transparent light
Time frame: post-operative follow-up at week1, month3, month6
Scrotal hematoma
Number of Participants with diagnosed through a physical examination showing a hard lump, bruising, abnormal skin color, and subcutaneous hemorrhage, sometimes with shallow rugae in the scrotum
Time frame: post-operative follow-up at week1, month3, month6
Hernia recurrence
Number of Participants with diagnosed through a physical examination showing intermittent bulge in the groin and can not get above mass
Time frame: post-operative follow-up at month3, month6
Testicular atrophy
Number of Participants with the testicular volume is reduced by 20% from pre- to post-operation after measuring the width, length and height of the testicles in centimeters, it is considered testicular atrophy.
Time frame: post-operative follow-up at month3, month6
Course of pain killer requirement
Measures the amount of painkiller medication used for less than or equal to 1 day or more than 1 day.
Time frame: post-operative follow-up at week1
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