PtFE vs Cierre de Pilares

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A Prospective, Randomized Trial of LaparoscopicPolytetrafluoroethylene (PTFE) Patch Repair

vs Simple Cruroplasty for Large Hiatal Hernia

Constantine T. Frantzides, MD, PhD; Atul K. Madan, MD; Mark A. Carlson, MD; George P. Stavropoulos, MD

Hypothesis:Largehiatalherniasareproneto disruption,resulting in reherniation, whenrepaired withsimplecru-roplasty. The useof mesh may decrease the rate of reher-niation in the laparoscopic repair of large hiatal hernias.

Design:Prospective, randomized controlled trial.

Setting:University-affiliated private hospital.

Patients:Seventy-two individuals undergoing laparo-scopic Nissen fundoplication with a hernia defect greateror equal to 8 cm in diameter.

Intervention: Nissen fundoplicationwith posterior cru-roplasty (n=36) vs Nissen fundoplication with poste-rior cruroplasty and onlay of polytetrafluoroethylene(PTFE) mesh (n =36).

Main Outcome Measures: Recurrences, complica-tions, hospital stay, operative time, and cost.

Results:Patients in both groups had similar hospitalstays, but the PTFE group had a longer operative time.The cost of the repair was $960$70 more in the groupwith the prosthesis. Complications were minor and simi-lar in both groups. There were 8 herniarecurrences(22%)in the primary repair group and none in the PTFE group

(P.006).

Conclusion: The use of prosthetic reinforcement ofcruroplasty in large hiatal hernias may prevent herniarecurrences.

Arch Surg. 2002;137:649-652

T

HE LAPAROSCOPIC tech-nique has revolutionizedthe approach to hiatal her-nia repair and the treat-

ment of gastroesophagealreflux disease. Traditionally, an enlargedhiatus is closed with interrupted large-gauge sutures.1 This method is prone todisruption and reherniation. One inves-tigation of 87 reoperations for gastro-esophageal reflux disease demonstratedthat 72% of patients experienced failureof their antireflux procedure because of thebreakdown of the hiatal hernia repair.2

A recent study has suggested that thelaparoscopic approach maybeinferiorto theopen approach for large hiatal hernia.3 Therecurrence rate for open simple cruro-

plastyintheir study, however,wasstill15%.Othershave demonstrateda similar high re-currence rate (10%-50%) even in the openapproach.4,5 The diaphragmaticrepair maybe more susceptible to disruption becauseof repetitive stresses of coughing, strain-ing,sneezing, andlaughing. Prostheses havebeen used effectively in other fascial de-fects such as inguinal hernias6 and ventralhernias.7 Previous preliminary reports byour group have described the use of poly-

tetrafluoroethylene (PTFE) for large hiatalhernia repair.8,9 No investigation with a sig-nificant sample size, however, has com-pared this repair with simple cruroplasty

alone.Thus, a prospective randomizedstudywas undertaken to compare theuse ofPTFEonly with simple cruroplasty in minimallyinvasive hiatal herniorrhaphy.

RESULTS

A total of 628 fundoplications were per-formed in the period between January 1,1991, and December 31, 2000. In this pa-tient population, 351 underwent a hiatalhernia repair. Seventy-two patients (11%of all patients receiving fundoplications,or 21% of patients with hiatalhernias) with

a hiatal defect of 8 cm or more were en-rolled in this trial (Figure).

There wasno significant difference inthemeanagebetweenthe2groups(Table).There were noconversionsin eithergroup.The operative time was about 30 minuteslonger in the PTFE group (Table). The in-creased operative time along with the costof the PTFE resultedin an increase in hos-pitalchargesof $960 $70inthePTFEgroupcomparedwiththesimplecruroplastygroup.

PAPER

From the Departments ofSurgery, Rush University,Chicago, Ill (Drs Frantzides,Madan, and Stavropoulos); andUniversity of Nebraska MedicalCenter, Omaha (Dr Carlson).

(REPRINTED) ARCH SURG/VOL 137, JUNE 2002 WWW.ARCHSURG.COM649

2002 American Medical Association. All rights reserved.by alejandrohernandez, on May 3, 2007www.archsurg.comDownloaded from
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Only complications that prolonged hospitalizationand/or resulted in patient distress were recorded. Thus,atelectasis and urinary retention, which did not delay dis-charge, were not considered complications. Also, minorabdominal wall hematomas and subcutaneous emphy-sema were not recorded as complications. Subcutaneousemphysemais often seen in patients after laparoscopic re-pair of large hiatal hernia. There were a total of 3 minorcomplications. The2 complications in thePTFE group in-cluded 1 case of pneumonia and1 of urinary retention thatdelayed discharge. Both patients did well after appropri-

atetreatment. Onepatient in thesimple cruroplasty groupdeveloped a pneumothorax. This complication was rec-ognized close to the end of the surgery by sudden tachy-cardia, hypoxia, increased peak pressures, and a protrud-

ing left hemidiaphragm. The procedure wasfinished withdecreased intra-abdominal pressure. Since adequate tidalvolumeswerenoted, no decompression was needed. Post-operatively, a chest radiograph demonstrated a minimalpneumothorax, which was followed up by daily observa-tion, delaying discharge. In retrospect, the longer hospi-tal stay in this case may not have been necessary.

Follow-up ranged from 6 months to 6 years (meanSD, 3.3 1.7 years; median, 2.5 years), with no patientsunavailable for follow-up. All patients (except 1) had atleast 1 year of follow-up. There was no difference in du-ration of follow-up between the 2 groups. All recurrenceswere symptomatic, although they were verified by bariumcontrast studies. Eight recurrences (22%) were noted in

the simple cruroplasty group, as opposed to none in thePTFE group (Table). All recurrences occurred within thefirst 6 months. Five patients with recurrence underwentreoperation (1 open and 4 laparoscopic). All patients re-ceived PTFE onlay as part of their second operation. Oneof these patients who required reoperation developed an-other recurrence. The other 3 patients with recurrenceelected not to undergo surgery and to be treated medi-cally.Neithererosions nor strictures of the esophagusfrommesh placement were seen. Infectious complications re-lated to the mesh were not observed.

628 Total Fundoplications

351 HiatalHernia Repairs (56%)

72 LargeHiatal Hernias

(21% of Total HiatalHernias; 11% of Total

Fundoplications)

Study population.

Simple Cruroplasty vs Cruroplasty With PTFE*

SimpleCruroplasty

CruroplastyWith PTFE

Sample size, No. 36 36

Age, mean (range), y 63 (42-81) 58 (36-92)

Duration of surgery, mean SD, h 2.1 0.3 2.6 0.5Hospital stay, d 2 2

Complications, No.

Minor 1 2

Major 0 0

Conversions, No. 0 0

Recurrences, No. (%) 8 (22) 0

*PTFE indicates polytetrafluoroethylene.P.006.

PATIENTS AND METHODS

The study was approved by our institutional reviewboards, and informed consent was obtained from allsubjects. All patients with hiatal hernias (types I toIV) were consideredfor the study. Presence of a hia-tal herniawas determinedby video esophagogram andesophagogastroduodenoscopy. Patients with dyspha-

gia, odynophagia, or dysmotility on the esophago-gram underwent manometry. Anypatient with a hia-tal defect of 8 cm or larger was enrolledin the study.The 8-cm defect cutoff was chosen empirically.

Preoperative antibioticswere given with the in-duction of anesthesia. Our technique of laparo-scopic hiatal hernia repair has been described in de-tail previously8-11; briefly, thehernia contents andthesac are reduced. The lower 4 to 5 cmof esophagus ismobilized into the abdomen. A cruroplasty is per-formed with interrupted 2-0 nonabsorbable su-tures; each suture incorporates large (1 cm) bitesof both crural muscle and fascia.

In the PTFE group, interrupted 2-0 nonabsorb-able crural sutures were placed and tightened up to

the point to provide a nontension approximation. Forthe onlay repair, an oval sheet (13100.1 cm) offenestrated PTFE (DualMesh Gore-Tex; W. L. Gore& Associates, Inc, Phoenix, Ariz) was used. A radialslotwith a 3-cmdefect inthe center ofthe oval (key-hole) was cut into the PTFE. The mesh was securedto the diaphragm and the crura with a straight herniastapler (Ethicon-EndoSurgery,Cincinnati,Ohio).The2 leaves of thekeyhole were then stapled to each other.

All patients received a 3-stitch(3 cm long),360Nissen fundoplication performed over a 60F esopha-geal bougie. The most cephalad stitch of the fundo-plication incorporated either the anterior arch of theright crus (simple cruroplasty group) or the prosthe-sis and the anteriorarchof the rightcrus (PTFEgroup).

Allpatients were seen postoperativelyat 1 week,

2 weeks, 1 month, 3 months, and then yearly. At 3months,an esophagogastroduodenoscopy and esopha-gogram were performed in all patients; a repeatedesophagogramwas done thereafterevery 6 months. Anycomplaintof chest pain or pyrosis wasevaluated witha barium contrast study and a clinic visit.

Operative time, hospitalization, complications,conversions, and recurrences were recorded. Two-tailed Fisher exact testand 2-tailedunpaired t tests wereperformed with GraphPad InStat Version 1.12a soft-ware (GraphPad Software, Inc, San Diego, Calif) asappropriate. Significance was defined asP.05.




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COMMENT

Although more expensive and slightly longer, the tech-nique with an onlay PTFE patch for large hiatal herniaresults in a lower rate of recurrence. It has been wellknown that, for appropriate healing, tissues must be heldtogether in a tension-free manner. Inappropriate ten-sion predicts failure of tissue approximation. When per-forming anastomosis and abdominal wall herniorrha-

phy,most surgeonstry to follow thisprinciple universally.By the same logic, tension-free hiatal hernia repairs shouldbe performed. If there is excess tension on the hiatal her-nia repair, the use of a mesh as a buttress helps decreasethe tension on the repair. Also, the onlay patch but-tresses the cruroplasty against the frequent mechanicalperturbations that the diaphragm undergoes.

Recurrence rates after simple cruroplasty for largehiatal hernias were unacceptable in the present study, asin other investigations.3-5 In a recent review of more than10000 laparoscopic fundoplications, early reherniationhas been cited as a frequent complication.12

In the present study, we have described the first, toour knowledge, randomized controlled trial of pros-

thetic use in minimally invasive hiatal herniorrhaphy.Other techniques of tension-free repairs with mesh havebeen described. Onestudy used polypropylene mesh, gas-tropexy, and gastrostomy for the management of para-esophageal hernias.13 Another report described the useof multifilamented polyester mesh to laparoscopically re-pair large hiatal hernias.14 Again, although others havedescribed the use of mesh to close large hiatal defects ina limited number of patients, no true comparison withsimple cruroplasty has been performed.15-22

Huntington23 described a technique that used a re-laxing incision to allow a tension-free closure of the crura.A polypropylene mesh was used to close the defect fromthe relaxing incision. While this technique does pro-

vide closure of the crura, we have 2 major concerns. First,the added time and risk in creating a relaxing incisionseem unnecessary. Second, the useof polypropylenemesh,even if placed away from theesophagus,should beavoidedbecause of the reported risks. Others have demon-strated that erosion and stricture of the esophagus maybe caused by polypropylene mesh in both the laparo-scopic13,24 and open25 approaches. Complications asso-ciated with the use of polypropylene have been de-scribed as mesh extrusion, bowel erosion, fistulizationto gastrointestinal organs, and wound sepsis.26 These com-plications arise from the fact that polypropylene meshcreates substantial visceral adhesions to adjacent or-gans. Because of the aforementioned pitfalls, some au-

thors discourage the use of prosthetic materialsat the hia-tus.3,21,24,27

Our preference is a material that provides little po-tential for adhesion formation and fistulization, such asPTFE. Investigations have demonstrated decreased vis-ceral adhesion formation as well as normal diaphrag-matic motion on fluoroscopy with the use of PTFE.28 Re-pairof congenital diaphragmatichernias withPTFEyieldedexcellent long-termresults.29 Others17 have used PTFE, al-though they believed that intracorporeal suturing is nec-essary for securing the mesh. As described, we believe that

the laparoscopicherniastapling deviceis sufficient for an-choring the mesh on the diaphragm and crura.

Others have describedthe useof pledgetedsutures forlarge hiatal hernias.30 Although pledgeted sutures were notstudied duringthis investigation, they do notprovide a truetension-free repair. In fact, a high recurrence rate (42%)hasbeen reported even when pledgeted sutures were usedin the presence of increased tension during simple cruro-plasty.3 There is an assumption that pledgetsareless likely

than PTFE to cause complications such as erosion. How-ever, at least one case oferosionfrom a Teflon pledget froma fundoplication has been reported.31

Because of the proved risk of recurrence without re-inforcement in large hiatal hernias, theuse of mesh is rec-ommended. The PTFE mesh provides a buttress when tis-sueis under tensionandespecially when tissueis subjectedto stressfrom coughing,straining,retching,or obesity.Thisinvestigation demonstrates that the use of meshreinforce-ment in laparoscopic hiatal hernia repair, as opposed tosimple cruroplasty, eliminates recurrent herniation.

Dr Carlson is supported by Mentored Clinical Scientist De-velopment Award 1 K08 GM00703-01A1 from the National

Institutes of Health, Bethesda, Md.This paper waspresented at the 109th Scientific Session

of the Western Surgical Association, San Antonio, Tex, No-vember 12, 2001.

Corresponding author and reprints: Constantine T.Frantzides, MD, PhD, Director of Minimally InvasiveSurgery, Department of General Surgery, Rush Presbyte-rian St Lukes Medical Center, Rush Professional Bldg,Suite 818, 1725 W Harrison Ave, Chicago, IL 60612(e-mail: [email protected]).

REFERENCES

1. RossettiME,Liebermann-MefferetD.Nissenantireflux operation.In: NyhusLM, BakerRJ, eds.Mastery of Surgery. Boston, Mass: Little Brown & Co; 1992:743-757.

2. Stirling MC, Orringer MB. Surgical treatment after the failed antireflux opera-tion.J Thorac Cardiovasc Surg. 1986;92:667-672.

3. Hashemi M, PetersJH, DeMeesterTR, et al.Laparoscopic repairof large type IIIhiatal hernia: objective followup reveals high recurrence rate. J Am Coll Surg.2000;190:553-560.

4. AckermannC, Bally H, Rothenbuehler JM, Harder F. Surgery in para-esophagealhernia: technique and results [in German]. Schweiz Med Wochenschr. 1989;119:723-725.

5. Ellis FHJr, Crozier RE,SheaJA. Paraesophagealhiatus hernia. ArchSurg. 1986;121:416-420.

6. Leichtenstein IL, Amid PK, Shulman AG. The tension-free hernia repair of groinhernias.In: NyhusLM, CondonRE, eds. Hernia. 4thed. Philadelphia, Pa:JB Lip-pincott; 1995:237-247.

7. Luijendijk RW, Hop WC, van del Tol MP, et al. A comparison of suture repairwith mesh repair for incisional hernia. N Engl J Med. 2000;343:392-398.

8. Frantzides CT,CarlsonMA. Prosthetic reinforcement of posterior cruroplastydur-ing laparoscopic hiatal herniorrhaphy.Surg Endosc. 1997;11:769-771.

9. FrantzidesCT, Richards CG,Carlson MA. Laparoscopic repair of largehiatal her-nia with polytetrafluoroethylene.Surg Endosc. 1999;13:906-908.10. Frantzides CT, Carlson MA. Laparoscopic versus conventional fundoplication.

J Laparoendosc Surg. 1995;5:137-143.11. Frantzides CT,RichardsGC. A studyof 362consecutivelaparoscopic Nissen fun-

doplications.Surgery. 1998;124:651-655.12. Carlson MA, Frantzides CT. Complications and results of primary minimally in-

vasive antirefluxprocedures: a review of 10,735 reported cases. J AmColl Surg.2001;193:428-439.

13. Edelman DS. Laparoscopic paraesophagealhernia repair withmesh. SurgLapa-rosc Endosc. 1995;5:32-37.

14. Kuster GG, Gilroy S. Laparoscopic repair of paraesophageal hiatal hernias.SurgEndosc. 1993;7:362-363.

15. Pitcher DE, Curet MJ,MartinDT, Vogt DM,Mason J,Zucker KA.Successful lapa-roscopic repair of paraesophageal hernia.Arch Surg. 1995;130:590-596.




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16. Hawasli A,ZoncaS. Laparoscopic repairof paraesophagealhiatal hernia.AmSurg.1998;64:703-710.

17. PaulMG, DeRosa RP,PetrucciPE, Palmer ML,Danovitch SH.Laparoscopictension-free repair of large paraesophageal hernias.Surg Endosc. 1997;11:303-307.

18. Bueno R, Brooks DC. Laparoscopic repair of paraesophageal hernias: prelimi-nary results [abstract].Surg Endosc. 1993;7:128.

19. Cloyd DW. Laparoscopic repair of incarcerated paraesophageal hernias.SurgEndosc. 1994;8:893-897.

20. Johnson PE, Persuad M, Mitchell T. Laparoscopic anterior gastropexy for treat-ment of paraesophageal hernias. Surg Laparosc Endosc. 1994;4:152-154.

21. Behrns KE, Schlinkert RT. Laparoscopic management of paraesophageal her-nia: early results.J Laparoendosc Surg. 1996;6:311-317.

22. LuketichJD, RajaS, FernandoHC, et al.Laparoscopicrepairof giant paraesopha-

geal hernia: 100 consecutive cases. Ann Surg. 2000;232:608-618.23. Huntington TR. Laparoscopic mesh repair of the esophageal hiatus.J Am Coll

Surg. 1997;184:399-400.24. TrusTL, BaxT, Richardson WS,et al.Complicationsof laparoscopicparaesopha-

geal hernia repair.J Gastrointest Surg. 1997;1:221-228.25. Carlson MA, Condon RE, Ludwig KA, Schulte WJ. Management of intrathoracic

stomach with polypropylene mesh prosthesis reinforced transabdominal hiatushernia repair.J Am Coll Surg. 1998;187:227-230.

26. Bauer JJ, Salky BA, Gelernt IM, Kreel I. Repair of large abdominal wall defectswith expanded polytetrafluoroethylene (PTFE). Ann Surg. 1987;206:765-769.

27. Gantert WA, Patti MG, Arcerito M, et al. Laparoscopic repair of paraesophagealhiatal hernias.J Am Coll Surg. 1998;186:428-433.

28. Newman BM, Jewett TC, Lewis A, et al. Prosthetic materials and muscle flaps inthe repair of extensive diaphragmatic defects: an experimental study. J PediatrSurg. 1985;20:362-367.

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9:164-168.31. Baladas HG, Smith GS, Richardson MA, Dempsey MB, Falk GL. Esophagogas-tric fistula secondary to teflon pledget: a rare complication following laparo-scopic fundoplication.Dis Esophagus. 2000;13:72-74.

DISCUSSION

Philip E. Donahue, MD, Chicago, Ill: I wantto begin bycom-plimenting the authors for an innovative scientific study. It isthe largest prospective randomized paper of its type ever per-formed, and it will be widely quoted for many years in the sur-gery of hiatal hernia. There are several issues that require dis-cussion and confirmation before this presentation will be seenin its proper context. Thefirst one is about theselarge type I hia-tus hernias and the short esophagus. How do you explain theapparent absence of shortened esophagus? North of the border

about 25% of patients with gastroesophageal reflux and hiatushernia have shortened esophagus, andyet just southof the bor-der (Im not sure what latitude Milwaukee is), the shortenedesophagus appears. Have previousreports overestimated the in-cidence of short esophagus? Has widespread use of H2blockeror proton pumpinhibition eliminated transmural shortening ortransmural effects of reflux and consequent shortening?

I wonder, as a corollary to my first question, how manyof your patients with less than 8-cm hiatus hernias developedrecurrences. The total absence of recurrence in the 8-cm grouptreated with mesh is really amazing, and it is a startling con-clusion that will lead all programs to change their recommen-dations regarding mesh repair with large hernias.

The next question is about mesh repair: How about themore traditional things such as excision of the sac, complete

reduction of the herniated viscus beneath the diaphragm, andcareful suture approximation of the wrap with the fundopli-cation? If the use of mesh in all of the patients will help mostof us avoid a 22%recurrence rate with large hiatus hernia, meshuse must become a routine. I recognize the weakness of manyAmerican studiesthat dont have long-term follow-up, but ourlack of unified systems and various patient factors will pre-vent better longitudinal studies for some time.

In conclusion, I believe this is a compelling study. The au-thors deserve special recognitionfor an outstanding project,andI thank the Program Committee for the honor of beginning thisdiscussion of the paper and accompanying manuscript.

James A. Madura, MD, Indianapolis, Ind: I enjoyed thispaper very much andI wonderin your previous experiences whatrole G tubes have played. Weve always felt that doing this, par-ticularly in open operations, kept the stomach in the intra-abdominal position much better than when we didnot use one.Have you had experience with this in any of your studies?

Bruce M. Wolfe, MD, Sacramento, Calif: One of the con-cerns that many of us have had is that late erosion of meshthrough the esophagus may occur. I note that you wrapped themesh all theway aroundthe esophagus. It might be equally sat-

isfactory to close the hernia defect without putting the meshallthe way around the esophagus, thereby reducing the risk oflate mesh erosion of the esophagus. How did you decide youneed to completely encircle the esophagus with the mesh?

Dr Frantzides: First, I would like to thankDr Donohue forhis kind comments and insightful questions.RegardingDr Dona-hues first question about the short esophagus, as I mentionedin my presentation, we have not seen a single short esophagus,and I dont think it is a matter of latitude or a matter of geo-graphic location. With large hiatal hernias, especially with theopen approach, we hadgreat difficultyto reducethe hernia con-tent to visualize. I think it comes down to being able to mobi-lize the esophagus. The length of the esophagus is there; be-cause of the inability to reduce the esophagus and the contents,we thought that we were dealing with short esophagus. That is

why it is becoming more of a myth that there is such a thing; ifit exists, it is in an extremely small percentage.As faras the recurrences,I dont think it isa matter oftech-

nique because we used exactly the same technique in both groups.Bothgroups receivedposterior cruroplasty. It was done withthesame sutures, and it was done in the same manner, incorporat-ing good bites on the crura. I have to admit that at times in cer-tain patients, when you do the cruroplasty, you know more orless from the time that you complete the cruroplasty that this isgoing to recur. At times you see separation of the crura fibers,so I dont think it is a matter of technique. What made the dif-ference was the reinforcement with the prosthesis.

As far as the numbers of the smaller hiatal hernias and thenumber of recurrences, we are putting a paper together and myfellow will be gathering those results. I dont have these off thetop of my head right now, but it was much smaller. It was ap-

proximately 3%.Concerning Dr Maduras question about gastric (G) tubes,

at the Medical College of Wisconsin we were using the G tubeafter every open case of hiatal hernia repair due to primarily thebloating syndrome that these patients have. Since we hadto usean NGtube for a longtime, we felt that the G tube was more ap-propriateinthesepatients.Atthesametime,theGtubewasthoughtto anchor the stomach. With the laparoscopic approach I dontthink that we need to do that, since patients do not experiencethe bloating syndrome.If anchorageof the stomach is theobjec-tive,IdontthinkthattheGtubewouldbetheappropriatemethod;maybe a gastropexy would be a betterway. Butin this study, ob-viously, we didnt explore that option of the gastropexy. I dontfeel it is necessary. Thedisruptionof the hiatalherniorrhaphy isthe main and most important issue in the reherniation.

Lastly, regarding Dr Wolfes question, as far as erosionsby the polypropylene mesh, there are several studies that haveshown that it can erode through the esophagus, whether it isput circumferentially or reinforcing only the posterior cruro-plasty. PTFE has been shown with the ventral hernias andothertypes of herniasthatit is less prone to erode through tissue. Asfar as the circumferential placement, I feel that it is the bestway to place the mesh because it anchors it better around theesophagus. Also, it is not only the posterior part of the crurathat is weak; it isalso the anterior part. So by placing the meshcircumferentially, you reinforce both the anterior arch as wellas the posterior cruroplasty.



PtFE vs Cierre de Pilares

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