Preliminary Study of Hiatal Hernia Repair Using Polyglycolic Acid: Trimethylene Carbonate Mesh.

2012·0.17 MB·English

by  Massullo, James M.

S P
CIENTIFIC APER
Preliminary Study of Hiatal Hernia Repair Using
Polyglycolic Acid: Trimethylene Carbonate Mesh
James M. Massullo, MD, Tejinder P. Singh, MD, Ward J. Dunnican, MD, Brian R. Binetti, MD
ABSTRACT ablylowrecurrencerate.However,duetothepreliminary
and nonrandomized nature of the data, no strong com-
Background:Repairinglargehiatalherniasusingmeshhas
parison can be made with other types of mesh repairs.
been shown to reduce recurrence. Drawbacks to mesh in-
Additional data collection is warranted.
cludeaddedtimetoplaceandsecuretheprosthesisaswell
as complications such as esophageal erosion. We used a KeyWords:Hiatalhernia,Paraesophagealhernia,Bio-A,
laparoscopic technique for repair of hiatal hernias (HH) Laparoscopic repair.
(cid:1)5cm, incorporating primary crural repair with onlay fixa-
tion of a synthetic polyglycolicacid:trimethylene carbonate
(PGA:TMC)absorbabletissuereinforcement.Thepurposeof
thisreportistopresentshort-termfollow-updata.
INTRODUCTION
Methods: Patients with hiatal hernia types I-III and de-
fects (cid:1)5cm were included. Primary closure of the hernia Large hiatal hernias (HH) are a challenging entity for prac-
defectwasperformedusinginterruptednonpledgetedsu- ticingsurgeons.AlthoughtheassociationofGERDandHH
tures, followed by PGA:TMC mesh onlay fixed with ab- is well known, many HH are asymptomatic. Large para-
sorbable tacks. A fundoplication was then performed. esophageal hernias (PEH) are frequently associated with
Evaluationofpatientswascarriedoutatroutinefollow-up symptomatology, leading patients to seek surgical treat-
visits. Outcomes measured were symptoms of gastro- ment. Elective repair has been proposed due to the poor
esophageal reflux disease (GERD), or other symptoms outcomesassociatedwithemergentsurgery,aswellasthe
suspicious for recurrence. Patients exhibiting these com- complications associated with the diagnosis.1
plaints underwent further evaluation including radio-
Thestandardofcareforrepairinghiatalherniasremainsa
graphic imaging and endoscopy.
controversy. Literature suggests a higher rate of recur-
Results: Follow-up data were analyzed on 11 patients. rence with laparoscopic repair compared to an open re-
Two patients were male; 9 were female. The mean age pair,withrecurrenceratesrangingfrom1.9%to42%.2,3In
was 60 years. The mean length of follow-up was 13 2007,Rathoreetal4publishedresultsofameta-analysisof
months.Therewerenocomplicationsrelatedtothemesh. 13studiesinvolving965patientsundergoinglaparoscopic
Onepatientsufferedfromrespiratoryfailure,onefromgas HHrepair.Theincidenceoftruerecurrencewasreported
bloat syndrome, and another had a superficial port-site as 25.5%.4 Regardless of the approach, there is no con-
infection.Onepatientdevelopedarecurrenthiatalhernia. sensus on the use of pledgets, gastroplasty, gastric fixa-
tion, or esophageal lengthening procedures. Repair of
Conclusions: In this small series, laparoscopic repair of
large hernia defects is technically challenging for most
hiatal hernias (cid:1)5cm with onlay fixation of PGA:TMC tis-
experienced surgeons. High recurrence rates have led to
suereinforcementhasshort-termoutcomeswithareason-
the use of mesh reinforcement. In 2006, Johnson and
colleagues5 published a meta-analysis of the literature
DepartmentofGeneralSurgery,AlbanyMedicalCenter,Albany,NewYork,USA
supportingtheuseofprostheticmaterialsfortherepairof
(allauthors).
large PEH. Different synthetic and biologic mesh types
Dr.TejinderP.SinghisaspeakerforCovidienandEthicon.Dr.WardDunnican
wasagrantrecipientfromCovidien,Ethicon,andNOSCARandconsultanttothe have been used, resulting in various outcomes.5 In 2008,
CowenGroup.Drs.MassulloandBinettihavenoconflictsofinterestorfinancial GoreintroducedBIO-Atissuereinforcement(W.L.Gore,
tiestodisclose.
Flagstaff, AZ). This material consists of a unique Polygly-
Addresscorrespondenceto:JamesM.Massullo,MD,5131BeaconHillRd,Suite colicacid:Trimethylenecarbonate(PGA:TMC)absorbable
230,Columbus,OH43228,Telephone:[phone],Fax:[phone],E-mail:
syntheticpolymer.Ithasanopenmatrixstructurethatacts
[email protected]
asascaffoldfornativetissuein-growth.6Todate,nodata
DOI:10.4293/108680812X13291597715943
havebeenpublishedregardingtheuseofthisproductfor
©2012byJSLS,JournaloftheSocietyofLaparoendoscopicSurgeons.Publishedby
theSocietyofLaparoendoscopicSurgeons,Inc. therepairofhiatalhernias.Ourseriespresentsshort-term
JSLS(2012)16:55–59 55
PreliminaryStudyofHiatalHerniaRepairUsingPolyglycolicAcid:TrimethyleneCarbonateMesh,MassulloJMetal.
outcomes for patients who have undergone laparoscopic ately after fixation. A complete (Nissen) or partial (Tou-
hiatal hernia repair using BIO-A mesh. pet)fundoplicationwasperformedbasedonpreoperative
manometric testing. Patients with esophageal dysmotility
MATERIALS AND METHODS received a partial fundoplication. All wraps were con-
structed to 3cm in length around a 52Fr to 56Fr dilator,
Under IRB-approved guidelines, patients were consented
using 0-TiCron suture material. The same surgeon per-
forsurgery.Datawerecollectedinaretrospectivefashion.
formed all cases.
Patients with type I-III hiatal hernias and hiatal defects
(cid:1)5cm, determined at the time of surgery, were included Postoperatively, patients were placed on a clear liquid diet
in the analysis. Patients who were undergoing concomi- anddischargedhomeonasoftdiet.Patientswereevaluated
tant procedures (eg, sleeve gastrectomy) were excluded. atfollow-upvisitsscheduledapproximately2,6,12weeks,6
monthsthen1yearaftersurgery.Outcomesmeasuredwere
All patients had been evaluated preoperatively in clinic.
symptoms of GERD, epigastric/chest pain, or other symp-
Each patient underwent a complete history and physical
toms suspicious for recurrence. Patients with these com-
examination. Objective testing was either performed at
plaints underwent further evaluation including esophagog-
our institution or the referring institution and confirmed
raphyfollowedbyendoscopyifwarranted.
by us. At a minimum, patients underwent esophagogra-
phy,upperendoscopicevaluation,andmanometry.Anum-
RESULTS
ber of patients had ambulatory pH testing as part of their
GERD evaluation. Between March and September of 2008, 11 patients were
enrolled in this study. Two patients were male, 9 were
Thelaparoscopictechniqueforperformingahiatalhernia
female. Of these 11 patients, 2 presented with symptom-
repairhasbeendescribedelsewhere.7Inallcases,adequate
atic type III hiatal hernias, and 9 presented with GERD.
intraabdominalesophageallength,measuringatleast2.5cm
The mean age was 60 years (range, 42 to 85). The mean
without tension or recoil was ascertained. Primary cruro-
length of follow-up was 13 months (range, 11.6 to 15.7).
plasty was then performed using interrupted 0-TiCron
BMIsrangedfrom21.9to42.5,withanaverageof30.7.No
(TycoHealthcareGroupLP,Norwalk,CT)nonabsorbable
esophageal lengthening procedures were needed (eg,
suture material without pledgets. A 7cm x 10cm BIO-A
Collis gastroplasty). Hospital stay averaged 1 day. There
mesh was trimmed appropriately and arranged in an on-
werenocomplicationsrelatedtothemeshitself,including
lay fashion against the primary repair and around the
infection,erosionintoadjacentstructures,orfistulaformation.
distal esophagus. It was then fixed to both crural pillars
using absorbable tacks (Davol SorbaFix™ or Covidien Three patients (27%) developed postoperative complica-
AbsorbaTack™). Two to 3 tacks were placed through the tions. The first patient failed to wean from the ventilator
mesh into each pillar. Figure 1 shows the mesh immedi- aftersurgery,requiring24hoursofcareintheICUbefore
extubation. A second patient developed gas bloat, which
resolved under observation. The upper GI series in this
case showed no abnormalities. A third patient developed
a superficial infection at the umbilical trocar site. This
resolved with antibiotics and local wound care.
OnepatientreturnedwithsymptomsofGERDat14months
and was found to have a recurrent HH. Relevant informa-
tion on this patient is outlined in Table 1. Thus, the HH
recurrence rate was 9% (1/11). Of the 2 patients with
symptomatic Type III HH, neither had developed GERD
or recurrent HH at 1 year.
DISCUSSION
Thefirstelectivehiatalherniarepairwasreportedin1919
by Soresi.8 As interest grew through the mid part of the
twentieth century, the anatomy and physiology of this
Figure1.PGA:TMCmeshafterfixationtocruralpillars. diseasewaselucidated.Surgeonsdevelopedthetenetsof
56 JSLS(2012)16:55–59
ationofthemeshwithabsorbabletacksallowsthecomplete
Table1.
absenceofforeignmaterialafteroneyear.
CharacteristicsofPatientwithRecurrentSymptomsofReflux
andHH
It has been shown that patients with hiatal hernia have
Age 55yrs ultrastructuralabnormalitiesofthemusculartissueofthe
Sex F crura that are not present in patients with a normal gas-
BMI 29.3kg/m2 troesophageal junction.14 This may explain why repair
withmeshisassociatedwithlowerherniarecurrence.The
Comorbidities FM,HLD,IBS,chronicconstipation,
hypothyroidism,depression,allergic relationship between collagen and formation of hernias
rhinitis has been studied for some time. However, there are no
Tobaccouse No data on the possible relationship between collagen me-
tabolism and the formation of hiatal hernia.15 It is hoped
Steroiduse No
thatasmoreresearchisdoneinthisarea,bettertreatment
RevisionalSurgery No
techniques will evolve and operations could be tailored
Procedure HHrepair,Nissenfundoplication
based on a patient’s risk for recurrence.
HHType I
One limitation of this retrospective review is the evalua-
Perioperative none
tion of patients based on symptoms alone, as some pa-
complications
tients may have a clinically silent recurrent hernia. Other
FM(cid:2)fibromyalgia, HLD(cid:2)hyperlipidemia, IBS(cid:2)irritable bowel limitations are the small number of patients in our study
syndrome.
group, as well as the short duration of follow-up.
The follow-up data included 1 patient with a recurrent
hiatal hernia. Preoperatively, she presented with de novo
hiatal hernia repair that are still in use today. However,
symptoms of GERD, including heartburn and laryngo-
highrecurrenceratesafterhiatalherniarepairledtomod-
pharangeal reflux. The patient had been followed for
ifications of the original techniques to reduce the inci-
years by a gastroenterologist while her symptoms be-
dence of this complication.8 Before the development of
came worse and refractory to medical management,
prosthetic mesh, primary repair was considered the stan-
which included twice-daily proton pump inhibitors.
dard of care. Foreshortened esophagus, particularly in
Esophagram showed reflux into the upper one-third of
large paraesophageal hernias plays a recognized role in
the esophagus. Endoscopy revealed the presence of a
recurrence if not addressed.9 Hernia sac resection and
hiatalhernia.Esophagealmanometrywasnormalwitha
gastropexy have also been shown to be important in the
mean lower esophageal sphincter (LES) resting pres-
prevention of recurrence.10
sure of 19.5mm Hg and normal LES relaxation. Esoph-
ageal peristalsis and upper esophageal sphincter func-
With the development of prosthetic and biologic meshes
tion was normal as well. She underwent laparoscopic
andtheiruseinhiatalherniarepairs,recurrencerateshave
hiatal hernia repair with BIO-A mesh and Nissen fun-
improved.Currentliteraturefavorstheuseofmeshforthe
doplication over a 54-Fr dilator. In this case, the mesh was
repairofhiatalherniastolowerrecurrencerates.2–5How-
fixedusingtheCovidienAbsorbaTack.Shesufferednoperi-
ever,theuseofmeshisnotwithoutcomplications,which
operative complications and had an uneventful course
may include erosion into the esophagus, aorta, dia-
until 14 months later, when she reported intermittent
phragm, and esophageal stenosis.11–13 These events, al-
episodes of reflux. Barium esophagram revealed spon-
though rare, can cause significant morbidity.
taneous reflux with unwrapping of the Nissen and wid-
ening of the hiatus. Endoscopy confirmed unwrapping
In 2008, GORE introduced BIO-A tissue reinforcement, an
of the fundoplication and the presence of a recurrent
absorbablemeshthatactsasascaffoldforcellstolaydown
hiatal hernia.
new matrix material as it is absorbed.6 This may be advan-
tageous in avoiding complications such as erosion and in- Inadequacy of the HH repair and fundoplication must be
fectionbyminimizingforeignbodypresence.Asthemeshis the first area scrutinized as contributing to failure in this
slowly absorbed, cells associated with the inflammatory re- patient.Inthepresenceoftechnicaluniformityamongthe
sponsemigrateintotheintersticesofthemesh.Overapprox- group, an argument can be made against this. Although
imatelya6monthperiod,themeshiscompletelyabsorbed theircontributioninthiscaseisuncertain,thepatientwith
and replaced with the patient’s own connective tissue. Fix- recurrence had a couple of predisposing factors that can
JSLS(2012)16:55–59 57
PreliminaryStudyofHiatalHerniaRepairUsingPolyglycolicAcid:TrimethyleneCarbonateMesh,MassulloJMetal.
be attributed to failure, including preoperative resistance mesh fall within this range. Mesh complications in this
toPPItherapyandHH(cid:1)3cm.16Sofar,thepatienthasnot group of studies is also a rare event.
been symptomatic enough to desire another surgery.
More longitudinal data collection is needed to further
The most common types of mesh used for HH repair
define the role of mesh repair and optimal material to
today are PTFE, polypropylene, and biomaterial.17 It is
reduce the rate of recurrence for this disease. Large ran-
difficulttodeterminewhattheactualrecurrenceandcom-
domized controlled studies are lacking and would be a
plicationrateisforeachtypeofmesh.Areviewofrecent
beneficial pursuit.
literature regarding the most common types of mesh in
use is outlined in Table 2.18–30 Inclusion criteria for the
table were reports (cid:3)10 years old with at least 10 patients
CONCLUSION
where the laparoscopic approach had been used and at
least 6 months of follow-up took place.
In this small series, laparoscopic repair of hiatal hernias
The technical approach to HH repair, as well as the (cid:1)5cm with onlay fixation of PGA:TMC tissue reinforce-
types and sizes of hernias, varies among the studies in ment has short-term outcomes with a reasonably low
Table2.18–30Thatnoted,recurrenceratesinthegroupof recurrencerate.However,duetothepreliminary,nonran-
studiesrangefrom0%to14%.Thisspeakstotheimprove- domizednatureofthedata,nostrongcomparisoncanbe
mentinoutcomesoflaparoscopicHHrepaircomparedto made with other types of mesh repairs. Additional data
past reports.3–5 The short-term results with PGA:TMC collection is warranted.
Table2.
RecentlyPublishedRecurrenceRatesforLaparoscopicHHRepairwithVariousMeshTypes
Author Year MeshType n MeanFollow-up(mo) Recurrence(%) MeshComplication
Hazebroek18 2008 TiMesh 18 24 5.6 0
Soricelli19 2009 Polypropylene 91† 69 1.1 nc
Kepenekci20 2007 Polypropylene 164 24 1.8 0
Granderath21 2005 Polypropylene 50 12 8 0
Leeder22 2003 Polypropylene 14 46 14 0
Gryska23 2005 PTFE 130 64 0.8 0
Frantzides24 2002 PTFE 36 40 0 0
Casaccia25 2005 Polypropylene/ePTFE 27 27 3.7 0
Jacobs26 2007 SIS 92 36 3.3 0
Oelschlager27 2006 SIS 51 6 9 0
Strange28 2003 SIS 12 11 0 0
Lee29 2008 HADM 52 16 3.8 0
Wisbach30 2006 HADM 11 12 9 0
TiMesh(cid:2)lightweighttitanium-coatedpolypropylenemesh;PTFE(cid:2)polytetrafluoroethylene.
ePTFE(cid:2)expandedpolytetrafluoroethylene;SIS(cid:2)smallintestinesubmucosa;HADM(cid:2)humanacellulardermalmatrix.
†GroupCfromstudy,meshonlayoverprimarycruroplasty.
nc:esophagealerosionoccurredinonecase,butitwasnotclearwhetherthishappenedinthegroupofinterest.
58 JSLS(2012)16:55–59
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