Comparition of the Results of Inguinal Hernia Repair Using Laparoscopic Total Extra-peritoneal or Open Prolene Hernia System Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Pain scale
研究概览
简要总结
Abdominal wall hernias are common, with a lifetime risk of 27% in men and 3% in women.
Inguinal and femoral hernias are the most common affections faced by primary care physicians that require surgical intervention.
The most common hernia in both sexes is the indirect inguinal hernia. The male-to-female ratio is 9:1 for inguinal hernias and 1:3 for femoral hernias. Inguinal hernia repair is one of the most common operations undertaken in routine surgical practice.
Since the introduction of the Bassini method in 1887, more than 70 types of pure tissue repair have been reported in the surgical literature. Throughout the years, attention was paid to the recurrences that occur after the use of tissue approximation technique, in the literature it has been reported that they occur in up to 34% of cases, being that the actual incidence of recurrences it is underreported, therefore, the repair of the hernia with approximation of tissue has practically been abandoned.
The concept of tension free repair for hernias was introduced by Lichtenstein who explain that the prime etiologic factor behind most herniorrhaphy failures is the suturing together, under tension, of structures that are not normally in apposition. The technique of the hernioplasty with the use of mesh was not widely accepted at first, the expansion of the use of mesh expanded for years. The use of mesh increased from 7 per cent of all operations in 1992 to 51 per cent in 1996. Currently, groin hernia treatment is not standardized but, today, tension free mesh repair technique is regarded as gold standard. Based in the Stoppa technique, the laparoscopic hernia repair was developed in 1991. The most common laparoscopic techniques for inguinal hernia repair are transabdominal preperitoneal (TAPP) repair and total extraperitoneal (TEP) repair. The use of the laparoscopic technique was progressively increasing based on the advantages of minimal invasive procedures, but since the publication of Neumayer in 2004, where he reports a recurrent incidence in laparoscopic hernia of 10.1 % compared with 4% for open surgery, the use of laparoscopic repair declines considerably. Surgeons remain divided on the best technique for inguinal hernia repair: while more than half never perform laparoscopic inguinal hernia repair, today the laparoscopic technique for hernia repair is used in 28% of cases, of which 25% is used the TEP approach and is considered the best approach for bilateral inguinal hernia repair (17). Advantages and disadvantages of TEP are: faster return to usual activities, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries (18).
In 1999, Gilbert published the use of bilayer patch device, known as prolene ® hernia system (Ethicon; Somerville, NJ, USA) (PHS) to repair inguinal hernia. The unique feature of this polypropylene mesh device is that it has attached the component, its underlay patch provides a pre-peritoneal repair, a connector that has the desirable attributes of a plug and an onlay patch covers the back wall. In the literature, better results have been reported for PHS repair than for Lichtenstein repair. The advantages of the anterior repair of inguinal hernias are: low operative costs, short learning curve, reproducible results at all levels and the possibility of the use of local anesthesia.
The objective of this study is to compare the results of laparoscopic totally extra-peritoneal repair (LTEPR) with open prolene hernia system repair (OPHSR) retrospectively.
详细描述
In our environment, 10367 (10.41% of all surgeries) hernia repair are performed in one year, of witch 5797 (51.92%) are inguinal hernia repair, of them 2870 (49.51%) are performed laparoscopically and 2927 (50.49%) are performed using different open repair techniques.
All consecutive patients that underwent LTEPR repair of inguinal hernia from 2003 to 2007 and open OPHSR inguinal hernia repair from 2008 to 2015, were analyzed. A total of 577 patients were included divided in two groups, the LTEPR group 293 patients and in the OPHSR group 284 patient. The selection of patients for LTEPR was bilateral inguinal hernia or recurrence after open repair, for OPHSR was unilateral inguinal hernia or health condition with preference to regional or local anesthesia. The follow up of all patients was between 18 to 60 months (mean 38.10 month).
Setting The LTEPR group was operated by two surgeons with long experience in laparoscopic hernia repair in a public hospital. The selected patients were those with bilateral inguinal hernia or recurrent hernia after open surgery, patients with contraindication for general anesthesia and patients with low midline scar or Pfannenstiel incision were excluded. Patients of the OPHSR group were operated in a private hospital by medical specialists in surgery with experience in repair using PHS; patients under local anesthesia were excluded.
Operative technique Pre-op antibiotic shot of 2rd generation cephalosporin was given to all the patients.
For LTEPR, under general anesthesia and supine position the plane preperitoneal was developed using a kidney-balloon trocar (Covidien-Medtronic, New Haven, CT, USA) using the 45 degrees scope to evaluate the plane. After developing the preperitoneal space, a structural trocar (Covidien-Medtronic, New Haven, CT, USA) was inserted and the space inflated with gas with low pressure. One working 10-millimeter trocar was inserted in the midline high as possible, if was necessary one more 5-millimeter trocar was inserted under the first one.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For laparoscopic repair: bilateral inguinal hernia or recurrent hernia For open repair: Patients with unilateral inguinal hernia More than 18 years old. Both sexes
排除标准
- •Patient under 18 years old Patients who cannot sign the informed consent.
结局指标
主要结局
Pain scale
时间窗: 60 months
the patients were asked to classified their pair after surgery in visual analog scale from 0 to 10, being 0: no pain and 10 severe pain. (0: no pain, 1 to 3: mild pain, 4 to 6: moderate pain, and 7 to 10 severe pain.
complication after surgery
时间窗: 60 months
Complications were recorded from the records: type and number. Each type of complication is presented in a number of occurrences and calculates the percent of occurrence.
次要结局
- Diary activity performance(60 months)
- Scar satisfaction(60 months)
- sexual function(60 months)
研究者
Sergio Gabriel Susmallian
Head of the department of general surgery
Assuta Medical Center
