A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain.
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Return to normal activities
研究概览
简要总结
Chronic groin pain is a frequent cause for referral to general surgeons. In some cases this pain may be due to the presence of a hernia. However, if on clinical examination there is no palpable lump or bulge, the cause of the pain may be difficult to elucidate. Some of these patients may have the diagnosis of sportsman's groin. Other names which have been attached to this condition include Gilmores groin and sportsmans hernia. These conditions are more commonly associated with sportsmen and women but those who do not play sport may also receive this diagnosis. Sportsman's groin is thought to be a syndrome of weakness of the posterior inguinal wall without a clinically recognisable hernia. Differing explanations for sportsman's groin include avulsion of the conjoint tendon from the pubic tubercle, weakening of the transversalis fascia, tears in the internal or external oblique, superficial inguinal ring dilatation and abnormalities of the rectus abdominus insertion.
There is some evidence that pre peritoneal mesh placement in these patients may be beneficial. The theory being that the mesh prevents pressure transmission to the damages structures, allowing them to heal more rapidly.
Aim. To assess the potential benefit of pre peritoneal mesh placement using the TAPP technique in patients with chronic groin pain.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Groin pain (unilateral or bilateral) for at least 4 months. In this way, patients with temporary symptoms will be excluded from undergoing unnecessary surgery.
- •Tenderness over pubic tubercle or superficial inguinal ring.
排除标准
- •Aged less than 18 years Aged more than 50 years - due to increased incidence of sacro-iliac and hip pathology.
- •Bulge, lump or cough impulse consistent with inguinal or femoral hernia on clinical examination.
- •Patients unwilling or unable to provide informed consent. Medically unfit for general anaesthetic
- •Pregnant women
- •Diabetes - due to diabetic neuropathy
- •Steroid use
- •QST suggestive of nerve entrapment.
结局指标
主要结局
Return to normal activities
时间窗: 3 months
次要结局
未报告次要终点
