Appraisal Consultation Document: Laparoscopic surgery for inguinal hernia repair
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Appraisal Consultation Document
Laparoscopic surgery for inguinal hernia repair
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The Department of Health and the Welsh Assembly Government have asked the National Institute for Clinical Excellence (NICE or the Institute) to conduct an appraisal of laparoscopic surgery for inguinal hernia repair and update guidance issued to the NHS in England and Wales in 2001. The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for this appraisal by professional organisations and patient/carer and service user organisations. The Committee has developed preliminary recommendations on the use of laparoscopic surgery for inguinal hernia repair. This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website, www.nice.org.uk). Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. The process the Institute will follow after the consultation period is summarised below. For further details, see the Guide to the Technology Appraisal Process (this document is available on the Institute's website, www.nice.org.uk).
The key dates for this appraisal are: Details of membership of the Appraisal Committee are given in Appendix A and a list of the sources of evidence used in the preparation of this document is given in Appendix B. |
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Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation. |
| 1 | Appraisal Committee's preliminary recommendations |
| 1.1 | Laparoscopic surgery is recommended as a treatment option for the repair of inguinal hernia. |
| 1.2 |
In order to enable patients to choose between open and laparoscopic surgery (either by the totally extraperitoneal [TEP] or the transabdominal preperitoneal [TAPP] procedures), they should be fully informed of all of the risks (e.g. pain, numbness and serious complications) and benefits associated with each of the three procedures. In particular, consideration should be given to:
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| 1.3 | When a choice between TAPP and TEP for the repair of inguinal hernia is clinically appropriate, it is recommended that TEP should be the preferred procedure. |
| 1.4 | Laparoscopic surgery for inguinal hernia repair by TAPP or TEP should only be performed by surgeons who have received appropriate training and who regularly carry out the procedure. |
| 2 | Clinical need and practice |
| 2.1 | An inguinal hernia is a protrusion of a sac of peritoneum (often containing intestine or other abdominal contents) through a weakness in the abdominal wall in the groin. It usually presents as a lump, with or without some discomfort, which may limit daily activities and the ability to work. Around 98% of inguinal hernias are found in men because of the vulnerability of the male anatomy to the formation of hernia in this region. Inguinal hernias can occasionally be life-threatening if the bowel within the peritoneal sac strangulates and/or becomes obstructed. |
| 2.2 | In England, there were approximately 70,000 surgical repairs of inguinal hernia in 2001/02, affecting 0.14% of the population and utilising over 100,000 NHS bed-days of hospital resource. Of these procedures, 62,969 were for the repair of primary hernias and 4939 for the repair of recurrent hernias. |
| 2.3 | Surgical repair (herniorraphy) is undertaken in the majority of individuals presenting with inguinal hernia, to close the defect, alleviate symptoms of discomfort, prevent serious complications (that is, obstruction or strangulation of the bowel), and reduce the risk of recurrence. |
| 2.4 | The majority of hernia repairs are undertaken as elective procedures. However, serious complications requiring emergency surgery arise in 4.8% of people undergoing surgery for a primary hernia and 8.6% of people undergoing surgery for a recurrent hernia. Some individuals present with bilateral hernias, which may be repaired during the same operation, or at a later date, with up to 30% of people with a primary unilateral hernia going on to develop a hernia on the opposite side. |
| 2.5 | Traditional methods of open repair (e.g. the Bassini method), which repair the hernia defect by suturing, have not changed significantly since their introduction in the late 19th century. Recently, the availability of prosthetic meshes has led to an increase in the number of 'tension-free' methods of reinforcing the inguinal region. Open mesh methods of repair are classified as open flat mesh (OFM - for example, the Lichtenstein method), open preperitoneal mesh (OPPM - for example, the Stoppa and Nyhus methods), and plug and mesh repair (OPM - for example, the Rutkow method). Open methods of hernia repair are associated with postoperative pain and numbness because of the large inguinal incision. Open flat mesh repairs are thought to be the principal surgical method of hernia repair in the UK. |
| 3 | The technology |
| 3.1 |
Laparoscopic surgery is a minimal-access technique that allows the hernia repair to be undertaken without the need to open the abdominal wall. Small incisions are made for the laparoscope and operating instruments, and synthetic mesh is usually used to close the hernia and prevent recurrence. There are two main approaches for the laparoscopic repair of inguinal hernias.
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| 3.2 | The surgical approach to inguinal hernia repair is the main focus of this appraisal; other issues such as comparisons between TAPP and TEP and the use of laparoscopic surgery in special subgroups (for example, bilateral or recurrent hernia) are subsidiary considerations. |
| 3.3 | The potential benefits of using a laparoscopic approach include reduced postoperative pain, earlier return to normal activities and a reduction in long-term pain and numbness. The repair of bilateral hernias (including occult hernias detected during contralateral inspection at the time of a unilateral repair) may be undertaken during the same operation. |
| 3.4 | Laparoscopic surgery is associated with additional costs, for the endoscopy system (video unit, monitor and endoscope and CO2 insufflator) and instruments (that is, trocars, staplers, diathermy scissors or ports), although these may be reusable. The cost of laparoscopic surgery is highly dependent on whether disposable or reusable equipment is used. |
| 4 | Evidence and interpretation |
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The Appraisal Committee considered evidence from a number of sources (see Appendix B). | |
| 4.1 | Clinical effectiveness |
| 4.1.1 | Outcomes of interest against which the effectiveness of laparoscopic and open surgery was assessed were primary outcomes of recurrence and persistent pain, and secondary outcomes of the rate of complications and persisting numbness, the duration of the operation, length of hospital stay, time to return to normal activities and quality of life. |
| 4.1.2 | A systematic review of the literature identified 37 randomised controlled trials (RCTs) that compared laparoscopic with open mesh repair of inguinal hernias in a total of 5560 randomised participants. The effectiveness of laparoscopic surgery compared with different methods of open surgery (open flat mesh, open preperitoneal mesh and open plug and mesh) was presented separately for the TAPP and TEP laparoscopic methods of repair. The best available data (individual patient data, or aggregate data from studies) was used to generate a meta-analysis of the effectiveness of TAPP and TEP procedures for different outcomes of effectiveness. |
| 4.1.3 | Laparoscopic surgery was associated with a statistically significant increase in operation time compared to open methods of hernia repair. Meta-analysis of 16 RCTs of TAPP repair demonstrated an overall increase of 13.3 minutes (95% CI, 12.1 to 14.6) compared to open repair. Meta-analysis of eight RCTs of TEP repair demonstrated an overall increase of 7.9 minutes (95% CI, 6.22 to 9.6) compared to open repair. |
| 4.1.4 | Laparoscopic surgery was associated with a significantly shorter time to return to usual activities in all of the studies that measured this outcome. Meta-analysis of seven RCTs of TAPP repair reported a hazard ratio (HR) of 0.66 (95% CI, 0.58 to 0.75; p < 0.00001), corresponding to a return to normal activities approximately 3 days earlier than after open repair. Meta-analysis of five RCTs of TEP repair reported an HR of 0.49 (95% CI, 0.42 to 0.56; p < 0.00001), approximating to a return to usual activities 4 days earlier than after open repair. |
| 4.1.5 | Both TAPP and TEP procedures demonstrated a statistically significant reduction in persisting numbness compared to open repair. Meta-analysis of eight RCTs comparing TAPP and open repair reported a relative risk (RR) of numbness of 0.26 (95% CI, 0.17 to 0.40; p < 0.00001) in favour of TAPP repair. Meta-analysis of four RCTs comparing TEP with open repair reported an RR of 0.67 (95% CI, 0.53 to 0.86; p < 0.002) in favour of TEP. One trial reported no difference between laparoscopic surgery (RR 1.00, 95% CI, 0.06 to 15.71 for TAPP; RR 2.57, 95% CI, 0.11 to 62.38 for TEP) and open plug and mesh repair. One RCT of TAPP compared to open repair showed that the reduction in numbness was maintained at 5-year follow up (3% persistent numbness with TAPP compared to 23% with open flat mesh repair). |
| 4.1.6 | Overall, there were fewer cases of persisting pain at 1 year post-operation in both TAPP and TEP studies. Meta-analysis of eight RCTs of TAPP repair reported an RR of 0.72 (95% CI, 0.58 to 0.88, p = 0.001) in favour of TAPP. Meta-analysis of four RCTs of TEP repair reported an RR of 0.77 (95% CI, 0.64 to 0.92, p = 0.004) in favour of TEP repair. One RCT of TAPP compared to open repair showed that the reduction in pain was maintained at 5-year follow-up (2% persistent pain with TAPP compared to 10% with open flat mesh repair). |
| 4.1.7 | The rates of recurrence were similar in the trial groups. Meta-analysis of 15 TAPP RCTs reported a total of 26 recurrences out of 1052 TAPP procedures (2.5%) compared to 22 recurrences out of 1062 open repair procedures (2.1%) (RR 1.18, 95% CI, 0.69 to 2.02). Thirteen RCTs of TEP repair reported a total of 23 recurrences out of 1007 TEP repairs (2.3%), compared to 13 recurrences out of 1002 open repair procedures (1.3%) (RR 1.61, 95% CI, 0.87 to 2.98). |
| 4.1.8 | A number of studies reported adverse events, such as haematoma, seroma, wound-related infection, mesh infection, vascular or visceral injuries and port-site hernia. Laparoscopic repair (both TAPP and TEP) was associated with fewer cases of wound-related infection and haematoma. However, TAPP repair was associated with a higher incidence of vascular and visceral injuries compared to open repair (0.13% vascular injuries with TAPP compared to 0% with TEP and open repair; 0.79% visceral injuries with TAPP compared to 0.16% with TEP and 0.14% with open repair). |
| 4.1.9 | One RCT randomised 28 people to TAPP and 24 people to TEP. There was a trend towards an increased operation time with TEP, although this did not reach statistical significance. There were no statistically significant differences between the procedures in terms of intra-operative complications, incidence of haematoma, recurrence at 3-month follow up, or time to return to usual activities. |
| 4.1.10 | The effectiveness of laparoscopic surgery in the repair of recurrent (six trials of TAPP and five trials of TEP) and bilateral inguinal hernias (six trials of TAPP and six trials of TEP) was consistent with the overall results for primary surgery of unilateral inguinal hernias. |
| 4.1.11 | The Assessment Group evaluated the effect of surgeons experience on the duration of operation for laparoscopic repair (the 'learning effect'). Inexperienced surgeons (up to 20 procedures) were estimated to perform TAPP procedures in 70 minutes and TEP procedures in 95 minutes, compared to experienced surgeons, who were estimated to perform TAPP procedures in 40 minutes and TEP procedures in 55 minutes. |
| 4.2 | Cost effectiveness |
| 4.2.1 | The literature review identified seven economic evaluations of laparoscopic surgery for inguinal hernia repair - three based on economic models and four based on primary studies. Only two studies (submitted by Ethicon Endosurgery and BARD Ltd) were relevant to the UK setting. |
| 4.2.2 | Ethicon provided a re-analysis of data from the MRC Laparoscopic Groin Hernia Trial, taking into consideration the repair of occult bilateral hernias. This model was based on the assumption that bilateral repairs in 30% of people with occult hernias would prevent the need for subsequent operation, and reduced the incremental cost effectiveness ratio (ICER) for laparoscopic surgery from £55,549 per quality-adjusted life year (QALY), as reported in the MRC Laparoscopic Hernia Trial, to £15,000 per QALY. However, the model did not take into account the possibility that some people with occult hernias would not develop a clinically significant hernia. |
| 4.2.3 | The BARD submission compared the cost effectiveness of the Perfix plug (used in open plug and mesh repairs) to laparoscopic surgery on the basis of data presented in the previous guidance issued in 2001 (see Section 8 Related guidance). BARD estimated that open plug and mesh repairs may be cost saving on the basis of the assumptions that the additional device cost is offset by a reduction in the recurrence rate (0.5% Perfix plug compared to 2.2% with laparoscopic surgery reported in the previous guidance) and hospital stay. |
| 4.2.4 | The Assessment Group developed a Markov model that updates the paper by Vale l, Grant A, and McCormack K (unpublished data 2003). The cost and outcome of various laparoscopic (TAPP and TEP) and open techniques (OFM, OPPM, OPM) were assessed in 1-year cycles over 5- and 25-year time horizons. All individuals entered the model at the point of initial hernia repair by an open (OFM, OPPM or OPM) or laparoscopic (TAPP or TEP) method. In the first year, survivors were assumed to undergo a 3-month period of convalescence and return to full health. In subsequent years, individuals could be in a health state of no recurrence (with or without persisting pain or numbness), recurrent hernia proceeding to re-operation, recurrence without re-operation (at risk of emergency surgery for complications), or death (operative and all cause mortality). |
| 4.2.5 | Inputs to the economic model on the costs and EQ5D utility estimates for the different health states were based on data from the MRC Laparoscopic Hernia trial. Theatre costs (£6.40 per minute) and the in-hospital costs (£236 per day) were similar for open and laparoscopic procedures. The additional equipment and consumable costs of laparoscopic surgery were £167 per procedure with reusable equipment or £788 per procedure with disposable equipment. Baseline estimates for operation length, hospital stay, operative mortality, recurrence, re-operation, persistent pain and numbness, time away from usual activities and health state utilities were taken from the best available data identified during this systematic review. Relative differences in the effectiveness of the different methods of open and laparoscopic repair were based on the meta-analysis results for the various outcomes, which were applied to these baseline parameters. Probabilities, costs and utilities were not considered to be fixed but were assigned a probability distribution to reflect uncertainty about their values. The same annual risk of recurrence, pain, numbness and relative effect sizes was used for primary and subsequent procedures. A constant annual risk for persistent pain, numbness and recurrence was assumed when extrapolating from years 6-25 of the model. |
| 4.2.6 | The results from the model showed that laparoscopic surgery (using reusable equipment) was associated with an increased cost of between £100 and £400 per procedure. Also, QALY differences between all of the techniques were small. Incremental analysis found the OPM method to be the most cost-effective method of open repair, driven by the duration of operation and hospital stay, which was the shortest with this procedure. However, when the same duration of operation and hospital stay was assumed for all open procedures, this increased the cost of OPM and OPPM techniques compared to OFM, and OFM became the most cost-effective method of open repair. TEP dominated TAPP as it was less costly and more effective than the TAPP method of repair. The incremental cost of laparoscopic surgery compared to OFM was between £5000 and £12,000 per QALY at 5 years and between £2000 and £5000 per QALY at 25 years for TEP and TAPP, respectively. When the cost effectiveness of laparoscopic surgery was compared with OPM repair, laparoscopic surgery was not cost effective (with an ICER of £46,000-£606,000), and TEP was only cost effective (£20,000 per QALY) if the benefits extended for 25 years. |
| 4.2.7 | Sensitivity analysis for differences in the costs, utility and relative effectiveness of different methods of open and laparoscopic repair was undertaken to evaluate the effect of uncertainty in these areas, the majority of which had little effect on the cost effectiveness of laparoscopic surgery. However, the cost effectiveness of laparoscopic repair was shown to be highly dependent on the cost of the open repair comparator. |
| 4.2.8 | Sensitivity analysis, that assumed laparoscopic surgery did not improve the level of persistent numbness compared to OFM increased the incremental cost effectiveness ratio of TEP from £2000 per QALY at baseline to £4000 per QALY at 25 years. Sensitivity analysis that assumed that laparoscopic surgery did not improve the level of persistent pain increased the incremental cost effectiveness ratio of TEP from £2000 per QALY at baseline to £8000 per QALY at 25 years. Assumptions that laparoscopic surgery did not confer any benefits of reduced persistent pain or numbness increased the cost effectiveness ratio of TEP to approximately £100,000 per QALY at 25 years. The use of reusable (approximately £170 per procedure) or disposable (approximately £790 per procedure) equipment in laparoscopic surgery had a huge impact on the cost effectiveness of surgery. Laparoscopic surgery using disposable equipment increased the incremental cost of TEP from £2000 per QALY at baseline to £14,000 per QALY at 25 years. |
| 4.2.9 | In a separate analysis, the Assessment Group modelled the effect of repairing occult bilateral hernias on the cost effectiveness of laparoscopic surgery. This led to an increase in the cost of laparoscopic surgery compared to OFM, and a reduction in the probability of recurrence (as it has already been repaired) in the first year, increasing the incremental cost effectiveness of TEP from £5000 per QALY at baseline to up to £10,000 per QALY at 5 years, depending on the prevalence and rate of progression of occult hernia. |
| 4.3 | Consideration of the evidence |
| 4.3.1 | The Committee reviewed the data available on the clinical and cost effectiveness of laparoscopic surgery for inguinal hernia repair, having considered evidence on the nature of the condition and the value placed on the benefits of laparoscopic surgery for inguinal hernia repair by people with the condition, those who represent them, and clinical experts. It was also mindful of the need to take account of the effective use of NHS resources. |
| 4.3.2 | The Committee heard evidence from experts that the incision resulting from open hernia repair may cause damage to the tissues and nerves, leaving some people with long-term pain and numbness. Experts further advised that all the open methods of repair (OFM, OPPM and OPM) would be expected to have similar incidence of persistent pain and numbness. |
| 4.3.3 | The Committee noted that laparoscopic repair of inguinal hernia was likely to result in considerably less long-term pain and numbness than open repair. However, the laparoscopic approach is associated with similar recurrence rates to that of the open procedure. The Committee considered that although laparoscopic surgery would be the preferred technique for the repair of recurrent hernias (as scar tissue from previous open repairs may be avoided) and bilateral hernias (repaired during the same operation), it should also be an option for primary repair of unilateral hernias because of the reduced incidence of long-term pain and numbness and the potential for earlier return to normal activities. |
| 4.3.4 | The Committee considered carefully the evidence from the RCTs on the potentially higher incidence of visceral and vascular injuries associated with the TAPP method of laparoscopic repair compared to both TEP and open procedures. Experts advised that this may have been a result of the relative lack of experience of surgeons in some of these early studies, and advised that there is currently no significant difference in the rate of adverse events between either of the laparoscopic procedures when performed by experienced surgeons. The Committee recommended that ongoing audit and review of the results of laparoscopic hernia repair should be established at a national level to ensure that these potentially serious events are identified and recorded in individual centres. |
| 4.3.5 | The Committee was unable to determine which of the two laparoscopic approaches should be preferred for routine surgery on the basis of clinical effectiveness or adverse outcomes when performed by experienced surgeons. However, the Committee was advised that the TEP approach enabled the surgeon to both view and, if required, effect a repair of an occult hernia on the contralateral side during a primary repair procedure. The TAPP approach also allowed an occult hernia on the contralateral side to be seen, but required more dissection to facilitate repair. The Committee was therefore persuaded that TEP should be the preferred method of laparoscopic repair where clinical features and surgical expertise permit. |
| 4.3.6 | The Committee considered that both the effectiveness and the cost effectiveness of laparoscopic hernia repair was closely linked to the experience of the surgeon in the technique. Therefore it noted the importance of ensuring appropriate standards of training. The Committee heard evidence from experts that whilst surgeons are being trained in laparoscopic surgery there is likely to be an increase in the duration of the operation, but were persuaded that this would not affect the overall longer-term cost effectiveness of the procedure. |
| 4.3.7 | The Committee considered it important that individuals be advised of the potential risk of complications associated with laparoscopic surgery. Laparoscopic surgery would not be appropriate for all, particularly those people unable to undergo general anaesthesia, or in situations where the size or location of the hernia defect does not lend itself to laparoscopic surgery. Experts advised that individual surgeons tend to have a favoured method of open or laparoscopic repair. The Committee concluded that individuals should be given impartial advice as to the relative risks and benefits of laparoscopic repair compared to open repair during discussions with the surgeon at the time of referral, in order to facilitate an informed choice. |
| 4.3.8 | The Committee reviewed the data on the cost effectiveness of laparoscopic repair compared to the different methods of open repair, and considered the OFM technique to be the most clinically relevant comparator because it is the most common method of open repair and because of the absence of long-term data on the costs and outcomes of newer techniques (OPPM and OPM). The Committee considered laparoscopic surgery (TAPP and TEP) to be a cost-effective alternative to OFM repair. |
| 5 | Proposed recommendations for further research |
| 5.1 | It is recommended that future trials report the utility of individuals undergoing laparoscopic surgery at 1 year and longer follow-up (where possible up to 25 years) to provide long-term data on the cost effectiveness of this technique. |
| 5.2 | The issue of chronic pain and numbness after inguinal hernia repair should be addressed prospectively in future studies using standard definitions to allow for the assessment of the degree of pain. |
| 5.3 | It is recommended that a registry be set up to monitor the incidence of serious adverse events (specifically the rates of visceral and vascular injury) associated with laparoscopic hernia repair and recurrence rates. |
| 6 |
Preliminary views on the resource impact for the NHS |
| This section outlines the Appraisal Committee's preliminary assessment concerning the likely impact on NHS resources if the recommendations in Section 1 were to be implemented. When guidance is issued, this section is intended to assist NHS planners and managers in its implementation. Therefore, the Institute particularly welcomes comments and information from those who would be involved in the implementation of the guidance so that this section can be made as helpful and robust as possible. | |
| 6.1 | Approximately 70,000 surgical inguinal hernia repairs are performed in England each year, at a cost to the NHS of £56 million a year. In the year 2001/02, 95.9% of mesh repairs were performed by open surgery, and 4.1% of repairs were performed by laparoscopic surgery. |
| 6.2 | The anticipated costs of adopting laparoscopic surgery are based on the degree of diffusion of this technique. However, experts advised that for the foreseeable future, it is unlikely that the uptake of laparoscopic surgery would exceed 40% of all surgical hernia repairs. If the annual percentage of laparoscopic repairs increased to 20%, the additional cost to the NHS in England would be approximately £1 million (based on the number and cost of hernia repairs in 2001/02 of £1078 for laparoscopic and £987 for open mesh repairs). |
| 6.3 |
The cost effectiveness of laparoscopic surgery for inguinal hernia repair is influenced by:
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| 6.4 | The duration of surgery is directly linked to the experience of the surgeon, thus there is an increased duration of operation with laparoscopic surgery as training operating surgeons progress through their learning curve. However, the duration of operation with open and laparoscopic repairs are likely to be of similar duration when performed by experienced surgeons which should lead to lower overall costs attributed to theatre time. |
| 6.5 | Hospital policy as to the use of reusable or disposable consumables will also have a significant impact on the cost of laparoscopic surgery. Reusable equipment for laparoscopic surgery costs about £170 per procedure compared to disposable equipment, which costs about £790 per procedure. |
| 6.6 | The Assessment Group model assumed a slightly higher recurrence rate for laparoscopic repair compared to open repair. If there is no difference in recurrence rates, then the cost effectiveness of laparoscopic surgery has been underestimated and the overall budget impact might be less. |
| 6.7 | There is likely to be regional variation in the implementation costs of this guidance depending on the degree to which of laparoscopic surgery is taken up locally, and variations in hospital policy towards, for example, the use of reusable or disposable equipment. |
| 7 | Proposals for implementation and audit |
| This section presents proposals for implementation and audit based on the preliminary recommendations for guidance in Section 1. | |
| 7.1 | Surgeons who carry out repair of inguinal hernia should review their current practice and policies to take account of the guidance set out in Section 1. |
| 7.2 | Local guidelines or care pathways for people who undergo surgery for repair of inguinal hernia should incorporate the guidance. |
| 7.3 | To measure compliance locally with the guidance, the following criteria could be used. Further details on suggestions for audit are presented in Appendix C. |
| 7.3.1 | Laparoscopic surgery is considered as a treatment option for the repair of inguinal hernia. |
| 7.3.2 | The individual undergoing repair of inguinal hernia is fully informed of all the risks and benefits associated with open surgery and laparoscopic surgery by both the TEP or TAPP procedures. |
| 7.3.3 |
In choosing between open and laparoscopic surgery (either the TEP or TAPP procedures), the following are considered:
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| 7.3.4 | TEP is used when a choice between either TAPP or TEP for the repair of inguinal hernia is clinically appropriate. |
| 7.3.5 | Laparoscopic surgery for inguinal hernia repair by TAPP or TEP is performed only by a surgeon who has received appropriate training and regularly carries out the procedure. |
| 8 | Related guidance |
| 8.1 |
National Institute for Clinical Excellence (2001) Guidance on the use of laparoscopic surgery for inguinal hernia. NICE Technology Appraisal Guidance No. 18. London: National Institute for Clinical Excellence. Available from www.nice.org.uk. |
| 9 | Proposed date for review of guidance |
| 9.1 |
The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review. |
| 9.2 |
It is proposed that the guidance on this technology is reviewed in August 2007. |
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David Barnett |
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Chair, Appraisal Committee |
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March 2004 |
| Appendix A. Appraisal Committee members and NICE project team. |
| A. Appraisal Committee members |
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NOTE The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members who took part in the discussions for this appraisal appears below. The Appraisal Committee meets three times a month except in December, when there are no meetings. The Committee membership is split into three branches, with the chair, vice-chair and a number of other members between them attending meetings of all branches. Each branch considers its own list of technologies and ongoing topics are not moved between the branches. |
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Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal. |
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The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website. |
| Dr Darren Ashcroft |
| Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical sciences, University of Manchester |
| Professor David Barnett (Chair) |
| Professor of Clinical Pharmacology, University of Leicester |
| Dr Peter Barry |
| Consultant in Paediatric Intensive Care and Honorary Senior Lecturer, Department of Child Health, Leicester Royal Infirmary |
| Mr Bryan Buckley |
| Lay representative, Vice Chairman, InContact |
| Professor Mike Campbell |
| Statistician, Institute of General Practice & Primary Care, Sheffield |
| Dr Mark Chakravarty |
| Head of Government Affairs and NHS Policy, Procter and Gamble Pharmaceuticals (UK) Ltd, Egham, Surrey |
| Dr Peter I Clark |
| Consultant Medical Oncologist, Clatterbridge Centre for Oncology, Wirral, Merseyside |
| Dr Mike Davies |
| Consultant Physician, University Department of Medicine & Metabolism, Manchester Royal Infirmary |
| Professor Cam Donaldson |
| PPP Foundation Professor of Health Economics, School of Population and Health Sciences & Business School, Business School - Economics, University of Newcastle upon Tyne |
| Professor Jack Dowie |
| Health Economist, London School of Hygiene |
| Professor Gary A Ford (Vice Chair) |
| Professor of Pharmacology of Old Age/Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust |
| Dr Fergus Gleeson |
| Consultant Radiologist, The Churchill Hospital, Oxford |
| Ms Sally Gooch |
| Director of Nursing, Mid-Essex Hospital Services NHS Trust, Chelmsford |
| Professor Trisha Greenhalgh |
| Professor of Primary Health Care, University College London |
| Miss Linda Hands |
| Clinical Reader in Surgery, University of Oxford |
| Professor Peter Jones |
| Professor of Statistics and Dean, Faculty of Natural Sciences, Keele University |
| Ms Joy Leavesley |
| Senior Clinical Governance Manager, Guy's and St Thomas' NHS Trust |
| Ms Ruth Lesirge |
| Lay representative, previously Director, Mental Health Foundation, London |
| Ms Rachel Lewis |
| Staff Nurse (Nephrology), Hull Royal Infirmary |
| Dr Ruairidh Milne |
| Senior Lecturer in Public Health, National Coordinating Centre for Health Technology Assessment, University of Southampton |
| Dr Neil Milner |
| General Medical Practitioner, Sheffield |
| Dr Rubin Minhas |
| General Practitioner with a Special Interest in Coronary Heart Disease, Primary Care CHD Lead, Medway PCT & Swale PCT |
| Mr Muntzer Mughal |
| Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust |
| Mr Richard Devereaux-Phillips |
| Public Affairs Manager, Medtronic Ltd |
| B. NICE Project Team |
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Each appraisal of a technology is assigned to a Health Technology Analyst and a Technology Appraisal Project Manager within the Institute. |
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Eleanor Donegan |
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Technical Lead, NICE project team |
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Dr Sarah Cumbers |
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Project Manager, NICE project team |
| Appendix B. Sources of evidence considered by the Committee | |
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A |
The Assessment Report for this appraisal was prepared by the Health Services Research Unit and the Health Economics Research Unit, University of Aberdeen.
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B |
The following organisations accepted the invitation to participate in this appraisal. They were invited to make submissions and comment on the draft scope and Assessment Report. They are also invited to comment on the ACD and consultee organisations are provided with the opportunity to appeal against the FAD. I Manufacturer/sponsors:
II Professional/specialist and patient/carer groups:
III Commentator organisations (without the right of appeal):
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C |
The following individuals were selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee's deliberations. They gave their expert personal view on laparoscopic surgery for inguinal hernia repair by attending the initial Committee discussion and/or providing written evidence to the Committee. They are invited to comment on the ACD.
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| Appendix C. Detail on criteria for audit of the use of laparoscopic surgery for inguinal hernia repair | |||
| Possible objectives for an audit | |||
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An audit could be carried out on the appropriateness of use of laparoscopic surgery for inguinal hernia to ensure the following.
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| Possible patients to be included in the audit | |||
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An audit could be carried out on all people referred for repair of inguinal hernia in a reasonable time period for audit, for example, 6 months or 1 year. | |||
| Measures that could be used as a basis for an audit | |||
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The measures that could be used in an audit of laparoscopic surgery for inguinal hernia are as follows. |
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Criterion |
Standard |
Exception |
Definition of Terms |
| 1. Laparoscopic surgery is considered as a treatment option for the repair of inguinal hernia | 100% of the people referred for repair of inguinal hernia | None | Surgeons will need to agree locally on how consideration of laparoscopic surgery as a treatment option is recorded for audit purposes. |
| 2. The individual undergoing repair of inguinal hernia is fully informed of all the risks and benefits associated with open and laparoscopic surgery | 100% of people referred for repair of inguinal hernia | None |
'Risks' include pain, numbness and serious complications. 'Laparoscopic surgery' means either the TEP or the TAPP procedure. Clinicians will need to agree locally on how an individual is determined to be 'fully informed' of risks and benefits for audit purposes. |
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3. In choosing between open and laparoscopic surgery, the following are considered: a. the suitability of the individual for general anaesthesia |
100% of people referred for repair of inguinal hernia | None | 'Laparoscopic surgery' means the TEP or the TAPP procedure.
'Nature of the presenting hernia' means primary repair, recurrent hernia or bilateral hernias. |
| 4. TEP is used when a choice between either TAPP or TEP for the repair of inguinal hernia is clinically appropriate | 100% of people having laparoscopic repair of inguinal hernia | A. The surgeon is not appropriately trained in TEP B. The patient does not choose TEP |
For a definition of 'clinically appropriate', refer to 3 a-d above. |
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5. Laparoscopic repair of inguinal hernia is performed only by a surgeon who: a. has received appropriate training and |
100% of people having laparoscopic repair of inguinal hernia | None | Clinicians will need to agree locally on what constitutes 'appropriate training' and how many procedures are needed to count as 'regularly' carrying out the procedure. |
| Calculation of compliance with the measure | ||
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Compliance (%) with each measure described in the table above is calculated as follows. | ||
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Number of patients whose care is consistent with the criterion plus number of patients who meet any exception listed |
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X 100 | |
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Number of patients to whom the measure applies |
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Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved. | ||
This page was last updated: 30 March 2010