跳至主要内容
临床试验/NCT07252999
NCT07252999招募中不适用

Transection Versus Reduction of Hernia Sac in Open Pediatric Inguinal Hernia Repair: A Randomized Controlled Trial Study

Piyanuch Lormuangthong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Reactive hydrocele

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Hernia sac transection

Experimental

Patients who underwent open inguinal hernia surgery using hernia sac transection technique.

干预措施: Hernia sac transection (Procedure)

Hernia sac reduction

Active Comparator

Patients who underwent open inguinal hernia surgery using hernia sac reduction technique.

干预措施: hernia sac reduction (Procedure)

结局指标

主要结局

Reactive hydrocele

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Course of pain killer requirement(post-operative follow-up at week1)

研究者

发起方
Piyanuch Lormuangthong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Piyanuch Lormuangthong

Principle investigator

Mahidol University

研究点 (1)

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