Assessing risks, costs, and benefits of laparoscopic hernia repair.

Annu. Rev. Medicine 1998. 49:95–109Copyright © 1998 by Annual Reviews Inc. All rights reserved

ASSESSING RISKS, COSTS, AND

BENEFITS OF LAPAROSCOPIC

HERNIA REPAIR

Muhammed Ashraf Memon, MBBS, DCH, FRCSI, FRCSEd,

FRCSEng

Laparoscopic Surgical Research Fellow, Department of Surgery, Creighton University

School of Medicine, Omaha, Nebraska 68131; e-mail: [email protected]

Robert J. Fitzgibbons, Jr., MD, FACS

Professor and Chief, Division of General Surgery, Creighton University School of

Medicine, Omaha, Nebraska 68131; e-mail [email protected]

KEY WORDS: hernia, inguinal surgery; surgery, laparoscopic; laparoscopic economics; cost-

benefit analysis; cost and cost analysis

ABSTRACT

Laparoscopic inguinal herniorrhaphy (LIHR) was introduced with the fol-lowing potential advantages: less postoperative discomfort and pain, re-duced recovery time that allows earlier return to full activity, easier repair ofa recurrent hernia, the ability to treat bilateral hernias concurrently, the per-formance of a simultaneous diagnostic laparoscopy, ligation of the hernia sacat the highest possible site, improved cosmesis, and decreased incidence ofrecurrence. Potential disadvantages include complications, such as bowel,bladder, and vascular injuries; potential adhesive complications at siteswhere the peritoneum has been breached or prosthetic material has beenplaced; the apparent need, at least at the present, for a general anesthetic; andthe increased cost because of expensive equipment needs. Most surgeonsagree that LIHR has a role in the management of patients with a recurrenthernia after a conventional inguinal herniorrhaphy (CIHR), bilateral inguinalhernia, or a need for laparoscopy for another procedure, such as laparoscopiccholecystectomy. The routine use of LIHR for the unilateral, uncomplicatedhernia is a more contentious issue.

0066-4219/98/0201-0095$08.00

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INTRODUCTION

Groin hernia is one of the most common afflictions of adults, especially men(1). The earliest recordings of medical history include discussions about effec-tive means of treatment. Approximately 500,000 to 750,000 herniorrhaphiesare performed in the United States each year (2–6). It was the most commonsurgical operation performed by general surgeons in the United States in 1991according to data from the National Center for Health Statistics, Hyattsville,Maryland (7). There are large, direct costs for the surgical procedure and sig-nificant indirect costs because of time away from normal activities. The over-all cost to society for treatment of this condition would be even greater if theestimated 800,000 patients per annum in the United States who choose not tohave their inguinal hernias repaired had changed their minds (8).

Many different types of surgical procedures are currently used to repair an in-guinal hernia, and there is a lack of consensus among surgeons concerning the bestprocedure. The perfect method for inguinal herniorrhaphy has yet to be developed.It is not surprising, therefore, that numerous modifications of existing proce-dures have been described and that new procedures are regularly being developed.

BACKGROUND

Modern surgical thinking concerning inguinal herniorrhaphy has been domi-nated by the principles first set forth by Bassini, who in 1884 developed a tech-nique for inguinal herniorrhaphy that included high ligation of the sac and re-inforcement of the inguinal floor (9). His operation was associated with alower operative mortality, and the recurrent hernia rate was one fifth of thatwhich was commonly accepted at the time. Modifications of Bassini’s repairhave been described by McVay (10), Halsted (11), Shouldice, and others(12–15) in attempts to further reduce the recurrence rate and to avoid compli-cations. Impressively low recurrence rates have been achieved with thesevariations in the hands of experts. However, postoperative pain has generallybeen considered excessive by both surgeons and patients, presumably result-ing from the tension created by suturing together tissues that are not naturallyin apposition (16). In addition, chronic groin pain syndromes have plaguedthese procedures. A randomized, prospective trial published from Canada byCunningham et al disclosed an astonishing rate of long-term pain after thesekinds of repairs (63% at 1 year and 53% at 2 years with 10% being severe) (17).Finally, in general surgical practice outside of specialty centers using any ofthese conventional methods, the recurrence rate requiring re-operation re-mains approximately 10%, as evidenced by a population-based study per-formed by the Rand Corporation and by the high incidence of recurrent herniasat enrollment in most published series (Table 1 & 2).

96 MEMON & FITZGIBBONS JR.

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Lichtenstein has popularized the concept of avoiding tension during her-niorrhaphy (18). He theorized that by using a mesh prosthesis to bridge the her-nia defect rather than closing it with sutures, as with the Bassini repair and itsmodifications, tension is avoided. He also felt that the lack of tension reducedthe incidence of suture pull-out, which resulted in his low recurrence rate of0.1%. Surgeons were slow to turn away from accepted dogma. Dr. Lichten-stein was largely ignored until the late 1980s. However, since that time therehas been rapid acceptance of the tension-free concept and, based on an infor-mal survey of a large group of surgeons attending an American College of Sur-

LAPAROSCOPIC HERNIA REPAIR 97

Table 1 Noncomparative trials of LIHR (series with >100 repairs)

Authors Year Percent ofherniasrecurrent atenrollment

Hernia Recurrencerate

Length offollow-up

n % months

Arregui et al (26) 1992 14 147 1.3 *

Fitzgibbons et al (37) 1993 14.5 867 4.5 34

Wheeler (53) 1993 5 135 0 18

Philips et al (54) 1995 1.6 3229 1.6 22

Corbitt (73) 1993 12 100 0 18

Felix et al (74) 1994 13 205 0 21

Felix (75) 1995 14 733 0.3 24

Felix (75) 1995 8 382 0.3 9

Geis et al (76) 1993 11 450 0.6 30

Hawasli (77) 1992 10 143 1.4 7

Himpens (78) 1993 17 100 2 *

Kald et al (79) 1995 17 200 3.5 24

Kavic (80) 1995 10 244 1 34

Newman et al (81) 1993 14 102 * 1

Paget (82) 1994 15 222 1.8 18

Panton (83) 1994 18 106 0 12

Quilici (84) 1993 5 173 0 *

Ramshaw (85) 1995 14 290 2.1 *

Ramshaw (85) 1995 16 118 0.5 *

Begin (86) 1993 53 200 0.5 18

Ferzli et al (87) 1995 11 326 1.6 22

Voeller (88) 1995 12 365 0 15

Rubio (89) 1994 * 120 0 48

* Information not available

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geons meeting (personal communication), a Lichtenstein type of operation hasbecome the method of choice by the majority of surgeons. Modifications ofLichtenstein’s operation have now been described using prosthetic plugs (19)or preformed prosthetic sheets, which have a rigid border that can be deformedfor manipulation through a small incision. These prosthetic sheets spring backto their original, flat shape when placed on the preperitoneal side of the herniadefect and will cover the entire inguinal floor (Kugel hernia patch, SurgicalSense, Inc, Arlington, Texas; available commercially, but no peer review sci-entific study has been published yet). These modifications make the use ofvery small incisions possible, yet are consistent with the tension-free concept.

The late 1980s is especially important to the specialty of general surgery be-cause during this time therapeutic laparoscopic surgery, the first real innova-tion in general surgery in decades, was developed. Laparoscopic cholecystec-tomy became the standard procedure for symptomatic calculus gallbladderdisease, despite the absence of controlled clinical trials (20). Attempts weremade to modify many other general surgical operations so that they could beperformed laparoscopically. None has enjoyed the obvious success of laparo-scopic cholecystectomy. Pertinent to this discussion is the fact that the devel-opment of laparoscopic herniorrhaphy and the rise in popularity of the tension-free concept were chronologically parallel events.


Table 2 Noncomparative trials of CIHR (series with 1000 repairs)

Authors Year Technique Percent ofhernias re-current atenrollment

Hernia Recur-rencerate

Lengthoffollow-up

n % months

Welsh/Alexander (12) 1993 Shouldice 15 34374 1 Variable

Robbins & Rutkow(19)

1993 Mesh and plug 16 1583 0.1 28

Amid (90) 1995 Lichtenstein’smesh repair

N/A 4000 0.1 60

Hay et al (91) 1995 Shouldice/Bas-sini/Cooper’sligament repair

N/A 1647 8 68

Lichtenstein (92) 1987 Lichtenstein’smesh repair

19 6321 0.7 24–168

Read (93) 1975 OPPH/sutureclosure

6.6 1420 6.6 41

Rignault (94) 1986 OPPH/mesh 21 1151 2.2 12–168

Rutledge (95) 1993 Cooper’s liga-ment repair

11 1142 2 108

N/A = Not applicable because recurrent hernias were excluded, n = number, OPPH = openpreperitoneal herniorrhaphy, % = percent

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LAPAROSCOPIC INGUINAL HERNIORRHAPHY

Laparoscopic inguinal hernia repair (LIHR) was developed with the followingpotential advantages in mind: less postoperative discomfort and pain, reducedrecovery time that allows earlier return to full activity, easier repair of a recur-rent hernia because the repair is performed in tissue that has not been previ-ously dissected, the ability to treat bilateral hernias concurrently, the perform-ance of a simultaneous diagnostic laparoscopy, the highest possible ligation ofthe hernia sac, and improved cosmesis (21–25). In addition, it was theorizedthat LIHR might have a lower recurrence rate than conventional inguinal her-niorrhaphy (CIHR) because of the mechanical advantage gained by placing theprosthesis in the preperitoneal space and the tension-free nature of the repair(26, 27).

These potential advantages of laparoscopic herniorrhaphy must be inter-

preted in the light of the possible disadvantages of a laparoscopic approach.

These include complications related to the laparoscopy such as bowel perfo-

ration or major vascular injury, potential adhesive complications at sites

where the peritoneum has been breached or prosthetic material has been

placed, the apparent need, at least at the present time, for a general anesthetic,

and increased cost because of the expensive equipment needs (28). The con-

ventional operation can be performed under local anesthesia on an outpa-

tient basis, with minimal risk of intra-abdominal injury, and the cost is less

(29–31).The LIHRs performed earlier on in surgeons’ learning curves were plagued

by two serious flaws. The first was an unacceptably high recurrence rate that

approached 20% (32, 33), due to the nonscientific repair method of simply fill-

ing the defect with large plugs or sheets of prosthetic material, while failing to

address the weakened inguinal floor. This problem was soon identified, and

surgeons started routinely using a large, flat prosthesis to support the entire in-

guinal floor. This modification has tremendously improved the recurrence rate

in contemporary series. Table 1 is a summary of recently published non-

comparative, mainly single-center series of laparoscopic hernia repairs. The

recurrence rates are essentially the same as those reported with the conven-

tional method for studies of the same design (Table 2).The second flaw was an unacceptably high incidence of neuralgia (34–37).

This problem was also rapidly solved as surgeons became familiar with the

posterior abdominal wall anatomy as seen from the laparoscopic prospective.

Surgeons learned to avoid stapling in critical areas where nerves traverse. Only

now that such technical problems have been solved and the operation has been

standardized can the true benefits be assessed.


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BENEFITS OF LAPAROSCOPIC INGUINALHERNIORRAHPHY

Conventional (open) hernia repair methods such as Bassini, McVay, Stoppa,or Shouldice suffer from one major disadvantage, i.e. a slow and painful recov-ery process. This is attributed to a number of factors that include a large skinincision, injury to various nerves, entrapment of nerves by postoperative scarformation or by suture, and presence of tissue tension. It is now believed thatthe presence of tissue tension in a hernia repair plays a significant role in bothshort- and long-term pain and recurrence (38). The postoperative recoveryprocess, therefore, is generally better with a tensionless herniorrhaphy, such asLichtenstein (39). LIHR was envisioned to allow for the best of both worlds byavoiding a large groin incision and subsequent scarring and by placing theprosthesis in a tension-free manner. This would be most beneficial in patientswith recurrent hernia after a failed CIHR or with bilateral or other complicatedhernias.

In Table 3, 13 trials [9 randomized prospective (40–48) and 4 non-randomized (49–52) trials] comparing laparoscopic and conventional herniarepair have been summarized. All of the comparative trials except one (40)have shown a statistically significant benefit for LIHR patients over both ten-sion and tension-free CIHRs in one or more of the parameters studied. A re-cently published prospective randomized trial (48) that enrolled 997 patientsclearly showed that LIHR patients had significantly less postoperative pain, asmeasured by a visual analogue pain scale, returned to normal work and athleticactivities much faster, and had a significantly lower recurrence rate at the endof two years. In addition, the incidence of wound abscesses was significantlyless in the LIHR group.

THE RISKS ASSOCIATED WITH LAPAROSCOPICHERNIORRHAPHY

The overall complication rate with LIHR is slightly lower than in conventionalrepairs (28), but the difference is not great. Some of the complications associ-ated with LIHR have been more severe and life threatening than those seen inCIHR and include bladder and bowel perforation (42, 53), bowel obstructionor herniation at trocar sites (54–57), major vascular injury (58), and colovesi-cal fistula (59). Table 4 summarizes possible complications of laparoscopicherniorrhaphy by separating them into three groups: (a) those related to thelaparoscopy; (b) those related to the patient, i.e. general complications; and (c)those related to the herniorrhaphy. Except for complications unique to lapa-roscopy, the incidence of other complications is similar for both procedures.


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Complications related to the patient are minimized with CIHR when the opera-tion is performed under local anesthesia, although many patients find this ap-proach unacceptable. To summarize, the potential for severe, life-threateningcomplications is greater with LIHR than CIHR, although the overall incidenceof complications between the two procedures is similar (28). The question be-comes, “Does the benefit of LIHR justify the increased risk of severe compli-cations?”

COST CONSIDERATIONS

If one includes the factors of surgical procedure and time away from normaldaily activities, the estimated cost of repairing 500,000 to 700,000 inguinalhernias per annum is approximately $3 billion (2, 4, 5, 7, 8, 60). It has been es-timated that herniorrhaphies cause the loss of 10 million working days eachyear , at a cost that has not been precisely defined but is obviously significant.Failure of the primary hernia repair (i.e. recurrence) requiring re-operation fur-ther increases the management costs of this routine procedure.

Cost-Benefit and Cost-Effective Analysis

Cost-benefit and cost-effective analyses measure and compare the vital gainsand losses associated with different methods of patient management. Doubilet etal (61) described four important measurements for any event that is introducedinto clinical practice to improve costeffectiveness. These include (a) cost sav-ings; (b) effectiveness in improving health care; (c) cost savings, with an equalor better health outcome; and (d) additional benefit worth the additional cost.


Table 4 Complications (37)

Related to laparoscopy Related to the patient Related to the herniorrhaphy

I. BleedingA. Abdominal wallB. Intra-abdominalC. Retroperitoneal

II. Visceral injuryA. Bowel perforationB. Bladder perforation

III. Bowel obstructionA. Trocar or peritoneal clo-

sure site herniaB. Adhesions

IV. Diaphragmatic dysfunc-tion

V. Wound infectionVI. Hypercapnia

I. UrinaryII. IleusIII. Aspiration pneumoniaIV. Cardiovascular and

Respiratory insufficiencyV. Nausea and vomiting

I. NeurologicalII. Cord & testicularIII. HydroceleIV. Wound infectionV. Prosthetic infectionVI. SeromaVII. Retroperitoneal hema-

tomaForeign body reaction to

mesh

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COST SAVINGS According to Stahlgren (62), there are four ways to achieve cost

savings when treating an adult patient with an inguinal hernia: (a) avoid unneces-

sary operations; (b) perform outpatient or ambulatory surgery; (c) reduce the

cost of the operation and hospitalization; and (d) minimize the incidence of re-

currence and wound infection by using appropriate surgical techniques with

known results.

Avoid unnecessary operations Surgeons routinely recommend elective in-guinal herniorrhaphy at the time of diagnosis for two reasons: fear of hernia ac-cident, i.e. obstruction and /or strangulation, and progression of the hernia withtime, making repair more difficult (63). In fact, the natural history of a groinhernia is not known. At the present time, there is no predictor of which herniawill become strangulated or when strangulation might occur. Since inguinalherniorrhaphy is currently performed routinely on diagnosis, there are no re-cent data documenting the incidence of hernia accident in adults.

An analysis of hernia management without operation was performed by

Neuhauser (64) that combined unpublished data from Cali, Colombia, in the

1970s with data from a study published in 1896, which described 10,000 pa-

tients enrolled in Berger’s truss clinic in Paris. The author found the annual

risk of a hernia accident for all ages to be 0.00291–0.0037. The incidence of

strangulation in patients 65 years of age was estimated to be 0.00291/year, or

0.044 during the remaining 15 years of life expectancy (64). Based on this an-

nual risk of a hernia accident and considering the life expectancy and operative

mortality rates for an uncomplicated herniorrhaphy in the Medicare population

from 1971, Neuhauser showed that elective operation has a greater loss of life

for a 65-year-old, although the absolute difference was negligible. Therefore,

in an older population, simple observation or truss may well be justified. Even

a truss, which costs between $80–100, including fitting, may not be necessary.

A recent report (65) revealed a truss to be uncomfortable and of no benefit in

controlling the hernia in the majority (69%) of patients. It was further sug-

gested that a truss may increase the incidence of complications and may make

eventual hernia repair more difficult. If hernia repair can be avoided altogether

in a significant number of patients, the impact on overall cost would be more

substantial than the difference between CIHR and LIHR.

Performing outpatient or ambulatory surgery Outpatient inguinal hernior-rhaphy can be performed for approximately half the cost of an inpatient proce-dure (66, 67). It is estimated that if one half of these procedures were per-formed in the outpatient setting, there would be a savings of approximately$200 million yearly in the United States. As Schultz (68) pointed out, promot-


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ing LIHR in more cost-efficient surroundings, such as an office surgical suite,could readily improve its acceptance by health-care insurers.

Reduce costs of the operation and hospitalization Most surgeons assumethat the laparoscopic procedure is more expensive because of the use of dispos-able items. Indeed, Schultz (68) showed the higher cost of LIHRs was secon-dary to the increased direct costs, which include supplies, equipment, and op-erating room charges. However, he concluded that this higher cost is offset bythe indirect savings in the health-care experience caused by the patient’s pre-dictable prompt return to unrestricted employment and resumption of produc-tivity. Schurz et al (69) also emphasized the use of cost-conscious techniques(i.e. avoidance of disposable equipment) as the key factor in offsetting highercost. Nevertheless, the authors conceded that despite all these measures, thecosts and charges of LIHR will never be as low as CIHR.

On the other hand, Lenker et al and others (70, 71) recently showed that

with the use of a strict cost-control protocol that eliminated all disposable

items except the hernia prosthesis and substituted epidural for general anesthe-

sia, the average cost for a herniorrhaphy could be made equal for LIHR and

CIHR. In fact, the authors showed that bilateral hernias actually could be re-

paired at a lesser cost laparoscopically than with a CIHR. It will be interesting

to see if the same results can be achieved when similar cost-control practices

are applied to both groups.

Minimize recurrence and complications There are a number of factors thatadversely affect patient outcome in inguinal herniorrhaphy, including (a) typeof hernia repair; (b) size of hernia; (c) surgical technique; (d) hemostasis; (e)avoidance of excessive tissue tension; and (f) comorbid conditions, such asrespiratory or cardiovascular diseases or obesity. These factors have beenshown to affect the incidence of recurrence and complications, both of whichcan magnify cost through such factors as prolonged hospital stay, prolongedcourse of antibiotics, reoperation, increased incidence of pain and disability,lost productivity, repeated follow-up outpatient visits, and the need for a sec-ond intervention (72).

Perioperative efforts to control these factors are extremely important. For ex-

ample, the incidence of wound infection following CIHR is estimated to be ap-

proximately 2% (100,000). Reducing this number even slightly would also lead

to significant savings because of the number of herniorrhaphies performed per

annum. A recent randomized, controlled prospective study found that the inci-

dence of wound infection with LIHR was significantly less than with CIHR

(48). Because LIHR is a very new procedure, it is reasonable to assume that

further modifications of the procedure will result in further decrease in the in-


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cidence of complications. Indeed, the two complications of trocar site hernia-tion (Figure 1; see color section, p. C-6) and neuralgia (Figure 2, p. C-7) wereidentified early and now have been virtually eliminated by closing all trocarsites and not stapling in inappropriate areas.

EFFECTIVENESS IN IMPROVING HEALTH CARE According to Doubilet et al(61), the term effectiveness means a strategy that is most sensitive to produc-ing desired results without consideration of its monetary value. When applyingthis term to LIHR, its effectiveness can be measured in terms of: (a) its abilityto repair bilateral hernias concurrently without additional incisions; (b) theperformance of a simultaneous diagnostic laparoscopy; (c) better patient out-come; and (d) a low recurrence rate compared to CIHR (48). The ability to re-pair recurrent hernias with a low recurrence rate has to be considered the mosteffective application of the laparoscopic repair.

COST SAVING, WITH EQUAL OR BETTER HEALTH OUTCOME A procedure thatcosts less but does not increase morbidity or mortality will have the universalblessing of both the medical and business communities. A day case CIHR un-der local anesthesia is quite cost effective. However, the patient’s recovery isslower, and some patients find local anesthesia with sedation unacceptable. Nolarge-scale prospective comparative trials combining cost and outcomes be-tween LIHR and CIHR are currently available.

COST BENEFITS WITH ADDITIONAL COST This term implies health outcomeassociated with monetary implications. A given strategy is more cost effectivethan another if it is (a) less costly and at least as effective; (b) more effectiveand more costly, its additional benefit being worth its additional cost; or (c)less effective and less costly, the added benefit of the rival strategy not beingworth its cost (61). The proponents of LIHR argue that the procedure falls un-der (b); i.e. although more costly, the superior patient outcome is worth theadded cost. Indeed all of the comparative trials except one (40) in Table 3 haveshown a statistically significant advantage for LIHR patients over both tensionand tension-free CIHR in one or more of the parameters studied (these includedecreased analgesia requirement in the immediate postoperative period,and/or earlier return to normal activity, and/or improvement in the overallquality of life as measured by validated instruments, and/or a decreased recur-rence rate).

CONCLUSIONS

LIHR is a new and evolving procedure that has the potential to significantlydecrease the pain and recurrence rate associated with this common operation,


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especially when compared to tension-related CIHRs. Widespread use oftension-free repairs outside of specialty centers is a recent phenomenon, and itis possible that these repairs might be as minimally invasive as LIHRs whileavoiding potential complications associated with laparoscopy. The best indi-cations now for LIHR are: (a) recurrent hernia after a CIHR, because the op-eration is performed in normal, nonscarred tissue; (b) bilateral hernias, sinceboth sides can easily be repaired using the same small laparoscopy incisions;and (c) the presence of an inguinal hernia in a patient who requires a lapa-roscopy for another procedure, such as a laparoscopic cholecystectomy (as-suming the gram stain of the bile is negative). A more contentious issue is theuse of LIHR for the uncomplicated, unilateral hernia. Large randomized, pro-spective trials will be needed to determine whether the added risks and costsare worth the benefits.

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Assessing risks, costs, and benefits of laparoscopic hernia repair.

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