Inguinal Hernia Repair
Conditions
Keywords
hernia sac transection, hernia sac reduction, open inguinal hernia repair
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHernia sac transection
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.
PROCEDUREhernia sac reduction
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.
Sponsors
Ramathibodi Hospital
Piyanuch Lormuangthong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male pediatric patients under 18 years old * Patients who underwent open inguinal hernia surgery on the affected side by a pediatric surgeon * Patients who had follow-up after inguinal hernia surgery at Ramathibodi Hospital or phone follow-up (Telemed) for 6 months * Patients who agree to participate in the study by signing an informed consent form
Exclusion criteria
* Preterm infants * Inguinal hernia patients with strangulated hernia * Patients with non-communicating hydrocele * Patients who had follow-up at another hospital after inguinal hernia surgery * Patients who refused to participate in the study or withdrawn
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactive hydrocele | post-operative follow-up at week1, month3, month6 | 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 |
| Scrotal hematoma | post-operative follow-up at week1, month3, month6 | 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 |
| Hernia recurrence | post-operative follow-up at month3, month6 | Number of Participants with diagnosed through a physical examination showing intermittent bulge in the groin and can not get above mass |
| Testicular atrophy | post-operative follow-up at month3, month6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Course of pain killer requirement | post-operative follow-up at week1 | Measures the amount of painkiller medication used for less than or equal to 1 day or more than 1 day. |
Countries
Thailand
Contacts
Primary ContactPiyanuch Lormuangthong, Doctor of medicine
Outcome results
None listed