Changing the Innate Consensus About Mesh Fixation in Trans-abdominal Preperitoneal Laparoscopic Inguinal Hernioplasty in Adults: Short and Long Term Outcome. Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- pain following lap hernioplasty with different method of fixation
研究概览
简要总结
Introduction: Inguinal hernioplasty is the standard treatment for inguinal hernia. Mesh fixation is used to keep mesh in place for which various mesh fixation techniques have been used in laparoscopic inguinal hernia repair, but their effectiveness has remained inconclusive.
Aim of the work: Randomized comparative study comparing early and late outcome of different method of mesh fixation.
Methods: In Zagazig University Hospitals, over the period from July 2016 to July 2018, patients with with oblique inguinal hernias undergoing Tans abdominal preperitoneal technique were randomized into 3 groups: Group A; mesh non fixation . Group B; tacker mesh fixation Group C: Cyanoacrylic tissue glues (Histoacryl) mesh fixation Clinical effects were assessed by the following variables: intraoperative data, postoperative outcome as regard recurrence rate, postoperative complications, analgesic consumption, operation time, hospital stay, and patient costs. Follow up was 18 months.
详细描述
Inguinal hernias are the commonest hernia met in clinical practice and accounts for 75% of abdominal hernia. Inguinal hernia repair is regarded as the standard treatment for adult symptomatic inguinal hernia following the international guideline for groin hernia management in which mesh is used to reinforce inguinal floor. Surgical mesh repair can be performed by open or laparoscopic techniques. Lichtenstein repair is commonly applied for open approach whereas trans-abdominal preperitoneal repair (TAPP) and totally extra peritoneal repair (TEP) are commonly used for laparoscopic approach.
During the repair of an inguinal hernia, sutures or tacks are generally used to secure the prosthetic mesh in place. In TAPP repairs the peritoneum is closed using sutures or tacks. These mesh fixation or peritoneal closure techniques may contribute to postoperative chronic pain presumably due to nerve irritation or entrapment .
Several techniques for mesh fixations have been used including suture, glue or self-gripping mesh for open hernia repair (OHR); metallic tack, absorbable tack, glue, suture, self-gripping mesh or even non-fixation techniques for laparoscopic hernia repair (LHR). Up to date, there have been eight systematic reviews and meta-analyses (SRMAs) on OHR (ie, glue vs suture (n=5) and self-gripping mesh vs suture (n=3) and one network meta-analysis (NMA For LHR, comparisons were tack and glue (n=6).
fixation versus no fixation (n=3) .Although evidences were interesting, the overall results were inconclusive. In mesh-based repair, flat mesh is recommended over three-dimension mesh, while self-gripping mesh is another alternative mesh..
Intraoperative strategies to reduce pain include the non-fixation of mesh or the use of non-mechanical methods of mesh fixation other than tacking or suturing, which may be less traumatic to the local tissue and less likely to cause local nerve entrapment. These non-mechanical methods include self-fixating meshes or glue. Similarly, closing the peritoneum with sutures may be less traumatic than the use of tacks, thus resulting in less postoperative 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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from 20 to 50
- •An uncomplicated oblique inguinal hernia.
- •Unilateral hernia
排除标准
- •Patients younger than 20 or older than 50 year old
- •Patients with complicated hernia
- •Bilateral hernia
- •Recurrent hernia
- •Patients with previous lower abdominal surgery.
结局指标
主要结局
pain following lap hernioplasty with different method of fixation
时间窗: 1.5 years
pain on visual analogue score
次要结局
- recurrence of the disease following lap hernioplasty with different method of mesh fixation(1.5 years)
研究者
Tamer Alsaied Alnaimy
assistant professour
Zagazig University
