跳至主要内容
临床试验/NCT03856710
NCT03856710招募中不适用

A Double-blinded Randomised Controlled Trial Comparing the Clinical and Cost Effectiveness of Self-fixating Versus Stapled Mesh in the Laparoscopic Management of Inguinal Hernia

Doncaster And Bassetlaw Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
47
试验地点
2
主要终点
Chronic pain rates Hernia recurrence rates

研究概览

简要总结

Inguinal (groin) hernias are common and occur when an internal part of the body pushes through a weakness in the surrounding tissue wall of the groin. They are more likely to occur in men and affect people's quality of life by causing pain that is worse after any strenuous activity. If untreated they can cause serious problems such as strangulation when too much bowel comes through the weakness and becomes squeezed with the risk of losing blood supply requiring emergency surgery. To prevent such complications, elective surgery for symptomatic inguinal hernias is undertaken either in the conventional open method which involves a cut in the groin, or the keyhole surgery, when the surgery is undertaken via three small incisions in the abdomen (instead of a single, larger groin incision), a thin tube containing a light source and a camera (laparoscope) is inserted through one of these incisions, so the surgeon can see inside the abdomen. Special surgical instruments are inserted through the other incisions, so the surgeon can pull or push the hernia back into place and a piece of mesh is then stapled or glued to secure it to the weakened area in the abdomen wall. Securing the mesh with staple has been associated with increased post-operative pain and analgesia requirement; whereas not doing so has been thought to increase the chances of recurrence- more so in large sized weakness. A newer mesh appears to offer benefit over conventional meshes as it grips the tissues around the weakness without requiring staples or glue to fix it in place, and has shown to cause lesser post-operative pain and recurrence.

This study is going to compare the newer self-gripping mesh with the conventional mesh requiring fixation to see which is best for patients undergoing keyhole repair to fix inguinal hernias.

详细描述

Design: Double Blinded Randomised Controlled Trial This is a multicentre randomised controlled trial in the setting of two district general teaching hospitals serving an aggregate population of over 750 000. There are already established general surgical clinics and operating sessions available for and including study patients. Both units undertake conventional open and laparoscopic treatments for inguinal hernias on a regular basis in keeping with the national average numbers.

Methodology; Patients with symptomatic unilateral or bilateral inguinal hernias diagnosed clinically &/or radiologically will be identified at general surgical clinics and the primary investigator, will arrange the following;

  • Assess inclusion / exclusion criteria for participation in study

  • Informed written consent for participation in the study

  • Baseline clinical severity and quality of life analysis using:

  • Euroqol (EQ5D)

  • Core Outcome Measures Index adapted for patients with hernia (COMI-hernia)

  • Informed written consent for intervention (the patient will be blinded as to the intervention group) Subjects; Patients will be identified during attendance to our general surgical clinics. Patients will be clearly informed that participation in the study is entirely voluntary and that refusal to participate will in no way disadvantage them.

Intervention (within 3 months of randomization);

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
Double (Participant, Outcomes Assessor)

盲法说明

Patients will be unaware of the type of mesh received as the randomisation process will be carried out intraoperatively when the patient is under general anaesthesia. Subsequently, over the follow-up period every possible effort will be made to continue the blinding process in order to minimise any bias in patient reported outcomes. Similarly outcome assessors would be blinded as well.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Demonstrated to have primary or recurrent unilateral or bilateral inguinal hernia
  • Both patient and surgeon occupy a position of equipoise over the relative merits of either intervention
  • Ability to give informed written consent

排除标准

  • Non-elective acute presentation with inguinal hernia and its complications
  • Inability to give informed written consent
  • Groin symptoms which on clinical examination and radiological investigations fail to demonstrate any evidence of inguinal hernia.
  • Pregnancy

结局指标

主要结局

Chronic pain rates Hernia recurrence rates

时间窗: 12 months

Pain persisting beyond 3 months post inguinal hernia surgery

Hernia recurrence rates

时间窗: 12 months

Clinical or radiological evidence of inguinal hernia at any time point

次要结局

  • Analgesia requirement(1 week)
  • Quality-of-life improvement(12 months)
  • Technical success(1 day)
  • Operative time(1 day)
  • Perioperative complications including injury to organs, bleeding(1 day)
  • Return to work and routine activities(12 months)
  • Cost effectiveness of the two techniques by assessing incremental cost per QALY of the intervention(12 months)

研究者

发起方
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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