A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Post-op pain
研究概览
简要总结
Our recent prospective randomized controlled study comparing single-port vs. multiport laparoscopic total extraperitoneal inguinal herniorraphy (NCT 01660048) demonstrated superiority of the single-port technique in reducing post-op pain/analgesic requirements, quicker return to work/normal physical activities and improved cosmetic scar scores. During this study all patients underwent the initial extraperitoneal dissection with the distension balloon. However, the balloon itself costs AU $380 per device which represents a significant percentage of the overall cost of the procedure (when the hospital/operating rooms cost is approximately AU $2500 for a unilateral laparoscopic inguinal hernia repair) especially if only unilateral inguinal herniorraphy is performed.
The European Hernia Society Guidelines encourage the use of the distension balloon for the initial distension/dissection of the extraperitoneal space especially during the learning curve. This recommendation arises from the fact that during the conventional multiport repair the umbilical port allows only the insertion of the laparoscope and the extraperitoneal space cannot easily be dissected with the scope itself, especially in patients with well-developed linea alba extending down to the pubic symphysis, and the camera itself, if used as dissection device, would become smudged and it would have to be repeatedly withdrawn for cleaning. Yet this must occur since the extraperitoneal space must be dissected in the midline sufficiently for safe insertion of two additional 5 mm ports for insertion of dissecting instruments in order to complete the extraperitoneal space dissection and the repair.
With single incision laparoscopic surgery the use of the Triport™ system ensure that the port can be place under direct vision into the extraperitoneal space when the scope and two dissecting instruments can be safely inserted at the outset. In this way the extraperitoneal space can be dissected under direct vision. The balloon dissection is essentially a blind dissection even though the balloon distension is being observed by the scope, incorrect tissue planes can be entered ie the dissection can occur below the pre-peritoneal fascia exposing the nerves in the groin with the potential risks for nerve damage and entrapment. This is an argument that surgeons who practise transabdominal preperitoneal inguinal hernia repair use to justify their superior technique over the TEP repair because, in the TAPP repair, the peritoneum is carefully dissected free from and leaving the underlying preperitoneal fascia intact.
While the use of the balloon, when some 25 "pumps" of air are used during the insufflation, to create a significant space to place not only the two 5 mm ports but also to create a significant extraperitoneal dissection when usually only the lateral space and the hernia sac need to be dissected this is not always possible. In patients who have had previous lower abdominal surgery including previous anterior inguinal herniorraphy (especially if the mesh plug is used) the balloon dissention is normally judicious as one cannot predict whether there are any significant peritoneal or even bowel adhesions. Consequently, in such cases, the balloon distension is normally confined to an area just inferior to the umbilical port and superior to the pubic symphysis so that there is just enough extraperitoneal dissection to place the two 5 mm trocars. Usually this means only using only 5 pumps of air in the distension balloon for placement of two 5 mm trocars. Then the dissection of the extraperitonealy space under direct vision can take place. The use of the distension balloon in such cases represents an enormous waste of resources since AU $380 is spent just to create enough space to place the two 5 mm ports and hence allowing the insertion of the dissecting instruments. With the Triport+™ port the dissecting instruments can easily be placed in the extraperitoneal space and the dissection can begin under direct vision hence achieving the same safe dissection that TAPP surgeons claim to perform.
In this study we aim to look at the safety and efficacy of telescopic vs. balloon dissection by prospectively comparing a similar former group of patients to the ones who had previously undergone single-port inguinal herniorraphy with balloon dissection in our previous study (NCT 01660048).
All patients having surgical treatment of groin hernia at St Luke's and Holroyd Private Hospitals are subject to very careful assessment and study. All patients are requested to report immediately if there are any problems.
详细描述
This study will compare the extraperitoneal dissection during single-port laparoscopic total extraperitoneal repair of inguinal/femoral hernias using the traditional balloon dissection and the telescopic dissection techniques.
Laparoscopic hernia repair was first introduced in 1990. The uptake rate was slow to start off with such that in 1994 only 9.7% of all inguinal hernias were performed laparoscopically However, in 2012, the figure now stands at 48% Australia-wide. (www.medicareaustralia.gov.au). Indeed, in the State of New South Wales this figure stands at 51%, which means that it is the commonest operation performed for inguinal hernias in this State.
Up to 2009, the laparoscopic hernia repair involves the insertion of 3 ports: 10mm port in the infra-umbilical region for the camera via a 2 cm incision and 2 x 5 mm working ports usually in the midline for the dissecting instruments via 2 x 10 mm incisions. These ports are called secondary trocars which are usually sharp. Their insertion has the potential to cause bowel and vascular injuries.
The European Hernia Society guidelines (www.herniaweb.org) on the treatment of inguinal hernias have shown (conventional) endoscopic techniques to be associated with higher rates of port-site hernias and visceral injuries especially during the learning curve period.
A recent study of 37,000 gynaecological laparoscopies in the US showed a bowel injury rate of 0.16%; a third of these led to the death of the patients. 22% of all bowel injuries resulted from the insertion of secondary trocars (www.danaise.com/vascular_and_bowel_injuries_duri.htm).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 86 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients referred with inguinal/femoral hernias
排除标准
- •• workers Compensation cases
- •previous extraperitoneal intervention
- •unfit for a general anaesthetic
- •strangulated hernias
结局指标
主要结局
Post-op pain
时间窗: measured on day 1 and day 7
Post-op pain measured on day 1 and 7 using the visual analogue score of 0 to 10
次要结局
- • Conversion to multiport or open operation(up to one year)
- • Length of hospital stay(up to one year)
- operation time(participants will be followed for the duration of hospital stay, an expected average of 1 day)
- Analgesic requirements(up to one week)
- return to work or normal physical activities(up to one year)
- Quality of life health scores(up to 1 year)
- Cosmetic scar score(1 year)
- Recurrence of hernia(1 year)
- post-operative complications including urinary retention, wound infection, seroma formation, chronic pain, testicular atrophy(1 year)
- cost analysis of the ports used(up to one year)
研究者
Dr Hanh Minh Tran
Director
The Sydney Hernia Specialists Clinic
