跳至主要内容
临床试验/CTRI/2024/05/068146
CTRI/2024/05/068146尚未招募3 期

A Randomised Control Trial to compare Lichenstein versus Desarda technique for primary inguinal hernia repair in adolescents and young adults

All India Institute of Medical Sciences Raebareli1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Hernia recurrence in one year of follow-up.

研究概览

简要总结

Inguinal hernia is generally defined as protrusion of the contents of the abdominal cavity or preperitoneal fat through a defect in the inguinal area. Although incidence and prevalence reported in literature vary and is not precisely known, the lifetime chance of a person being operated for inguinal hernia is quiet high, 27% in men and 3% in women. As per European hernia society(EHS) guidelines published in 2009 for management of adult hernias state that Lichenstein technique or endoscopic methods should be used for repair of inguinal hernias in adults. This is in contrast to practice in paediatric population where high ligation of hernia sac is recommended. However, adolescent patients represent a “gray zone” between children and adults, and there is no consensus on the most appropriate surgery for inguinal hernias in these patients. Type of operation in these patients largely depends on the surgeon. Adult surgeons prefer to repair adolescent hernias with a mesh repair and pediatric surgeons tend to repair them with a high ligation of the sac. Although, mesh has been shown to be quite beneficial in terms of decreasing recurrence rates in inguinal hernias in adults, there are potential morbidities related to mesh use, such as chronic pain, seromas, infections, and infertility. Because of this, the avoidance of mesh may be preferable in inguinal hernia repairs in adolescents and young adults, if not at the sacrifice of increased hernia recurrence. Due to this, various mesh free tissue repair techniques have been described in literature. The most popular is the Shouldice repair technique, which is considered best among the non-mesh repair techniques with strength of recommendation level 1A. However, although the Shouldice method has recurrence rates of less than 1%, its technically demanding nature can potentially increase the incidence of recurrence of up to 15% with the less experienced and less trained hands. Therefore, other mesh free tissue repair techniques have been described throughout the literature one of which is Desarda mesh free tissue repair that was described by Dr Mohan P Desarda in 2001. The technique requires no complicated dissection or suturing, and is easy to learn as its developer claimed. Moreover, It does not require any foreign material and does not use weakened muscles or transversalis fascia for repair. Some authors have therefore concluded that the Desarda repair has the potential to become the new gold standard particularly in low-income and middle-income countries. Also, as results of Desarda technique appears promising in various studies in literature, a randomised control trial can be planned to compare this comparatively newer technique with the standard Lichtenstein technique of inguinal hernia repair, especially in adolescent and young adult population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
13.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • All adolescents and young adults aged between 13 years to 25 years diagnosed as case of inguinal hernia in department of paediatric surgery and department of general surgery and fit for regional/general anaesthesia.

排除标准

  • Patients below 13 years and above 25 years of age.
  • Patients with an aponeurosis that was divided, tiny, and/or weak.
  • Patients with recurrent or strangulated hernias.

结局指标

主要结局

Hernia recurrence in one year of follow-up.

时间窗: 1 year. | 6 months.

Occurrence of any chronic pain- defined as moderate (VAS 30 to 54) or strong (VASgreater than 54) pain lasting more than 6 months after surgery.

时间窗: 1 year. | 6 months.

次要结局

  • General and local complications(graded as per clavein dindo classification)(1 year)
  • ï‚§ Length of time to return to various levels of everyday activity{Return to normal activity will be defined as the patient’s ability to perform elementary activities [i.e., dressing, walking, bathing (basic activity)]; usual activities at home [i.e., preparing food, cleaning house (home activity)]; and returning to all previously performed activities (work activity)}(1 year)
  • ï‚§ Presence or absence of foreign body sensation, and abdominal wall stiffness in the groin area.(1 year)

研究者

发起方
All India Institute of Medical Sciences Raebareli
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rohit Kapoor

All India Institute of Medical Sciences, Raebareli

研究点 (1)

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