C R ASE EPORT Using the StomaphyXTM Endoplicator to Treat a Gastric Bypass Complication Melissa A. deWolfe, DO, Curtis E. Bower, MD ABSTRACT INTRODUCTION BackgroundandObjectives:Asthenumberofbariatric Obesityisbecominganincreasinglywidespreadepidemic operations performed increases, the number of patients in the United States. According to a study performed requiringreoperationforfailedweightlossisexpectedto between 1999 and 2004,1 the incidence of overweight proportionately increase. Natural orifice surgery is an al- children and adolescents has increased from 13.9% in ternative approach to revisional gastric bypass surgery 1999to2000to17.1%in2003to2004.Similarly,obesityin when postoperative complications, such as dilatation of adultshasincreasedfrom30.5%to32.2%duringthesame the gastrojejunostomy, gastrogastric fistula, and gastric time period. As a result, the number of weight loss sur- pouch, dilation occur. geries being performed in the United States has predict- ably increased from 13 365 in 1998 to more than 100 000 Methods: The present article reports on the safe and successfuluseofanendoscopictissueplicatingdevicein in2003.Thisupwardtrendinbariatricsurgeryislikelyto a patient found to have a dilated gastric pouch and a continue until the obesity epidemic is controlled. With gastrogastric fistula 12 years after an open, nondivided this, bariatric surgeons are now encountering the chal- RYGB. lenge of more and more patients who require revisional procedures secondary to failed weight loss or complica- Results: The procedure was performed without compli- tions. cations and resulted in a reduced pouch size to approxi- mately 30cc to 50cc and redirection of the flow of gastric Single institution case series2 indicate that revisions are contents through her gastrojejunostomy. The patient’s performedin5%to60%ofpatientswhohaveundergone earlysatietyreturnedand,1yearpostoperatively,shehad primary restrictive or restrictive-malabsorptive proce- incurred a 45-pound weight loss. dures. Approximately 10% to 40% of patients fail to Discussion:Themorbidityandmortalityofrevisiongas- achievelong-termweightlossafterRoux-en-Ygastricby- tric bypass was avoided while the patient’s goal of mod- pass (RYBG), usually secondary to dilation of the gastric erate weight loss was achieved. Tissue plicating devices pouch, and less commonly to gastrogastric (GG) fistula.3 offer an alternative for repair of some postbariatric com- Both open and laparoscopic surgical revision procedures plications. With the rapid advances in endoluminal tech- have been used for repair. However, surgical interven- nologyandincreasingexperiencewithnaturalorificesur- tion can be challenging and fraught with serious mor- gery, the ability to successfully address surgical problems bidities, even in the most experienced hands. Second- through less invasive means will continue to improve. ary to factors like extensive intraabdominal adhesions, ulcers, inflammation, bowel obstructions, and meta- KeyWords:Bariatricsurgery,Complications,Fistula,En- bolic disturbances leading to poor nutrition, revisional doscopy. surgery can lead to undesirable outcomes. These in- clude leak, obstruction, perforation, staple-line disrup- tion, blind loop syndrome, bleeding, stricture, sepsis, wound dehiscence, pulmonary embolism, and death.4 NaturalorificesurgeryusingtheStomaphyXendoplica- ECUDepartmentofSurgery,BrodySchoolofMedicine,Greenville,NorthCarolina, tor is an alternative approach to revisional gastric by- USA(allauthors). pass surgery when postoperative complications occur. Addresscorrespondenceto:CurtisE.Bower,MD,ECUDepartmentofSurgery,600 Its minimally invasive nature makes it a safe and prom- MoyerBlvd,Greenville,NC27834,USA.Telephone:(252)744-4251,Fax:(252) ising approach that may be associated with fewer intra- 744-3809,E-mail:[email protected] operativeandpostoperativecomplications.Thefollow- DOI:10.4293/108680811X13022985131570 ing case highlights the use of StomaphyX to restore ©2011byJSLS,JournaloftheSocietyofLaparoendoscopicSurgeons.Publishedby theSocietyofLaparoendoscopicSurgeons,Inc. weight loss in a patient after nondivided RYGB. JSLS(2011)15:109–113 109 UsingtheStomaphyXTMEndoplicatortoTreataGastricBypassComplication,deWolfeMAetal. CASE REPORT history, it has also been laden with failed operations and serious postoperative complications that require revision. A 45-year-old white female presented 12 years after an Because of the significantly higher perioperative compli- open, nondivided RYGB. Over the preceding 6 months, cationrate,theriskofrevisionalsurgerymustbebalanced she no longer experienced early satiety and gained 40 against its potential benefit. The risk of developing peri- pounds. An upper GI (UGI) revealed a dilated gastric operativecomplicationsafterrevisionalbariatricsurgeryis pouch and a GG fistula, which was confirmed on endos- 2to3timesgreater,andtheleakratemaybe5to10times copy.Thepouchwasestimatedtobe150ccto200ccwith higher. This is likely related to factors such as impaired a 2-cm GG fistula. The gastrojejunal (GJ) stoma was also tissue quality and markedly decreased blood supply in dilated. reoperative areas.5 Despite this, some authors advocate Thepatientelectedtoproceedwithnaturalorificesurgery operativerevisionforfailedweightloss,becauseofeven- using the StomaphyX device. The device did not allow tual improvement in comorbidities associated with obe- placement of plications directly at the fistula site, but did sity.6 allowplacementoffull-thicknessfastenersinaconcentric fashion from the GJ to the gastroesophageal junction. One study reviewed a prospective database of patients Pouch size was reduced to approximately 30cc to 50cc. undergoing both primary and open revisional bariatric AlthoughpostoperativeUGIshowedpersistentGGfistula, proceduresbetween1998and2007.Ofnote,inthisstudy italsoshoweddelayedflowthroughtheGJandamarked inadequate weight loss alone was not viewed as an indi- decrease in pouch size, which ultimately enabled the cationforrevision.A9-foldincreaseinleaks,a2-to5-fold patient to achieve her desired outcome of weight loss. increase in ICU utilization, and a 1.5-fold increase in lengthofstayinpatientsundergoingrevisionalcompared At 2 months after surgery, the patient had regained early with primary bariatric surgery was found. Despite this, satiety and lost 25 pounds. Now, nearly 1 year after her researchers had a 0% 30-day postoperative mortality rate gastric pouch endoplication, she continues to experience for revisions. They concluded that, in experienced hands early satiety and has lost 45 pounds. We will continue to and via the open approach, revisional bariatric surgery followthispatientandrecordherprogress,asmorelong- can be safe.2 Another case series reported on the out- termdataarenecessarytoevaluatethetrueefficacyofthis comes of 215 consecutive revisional bariatric operations procedure (Figure 1). performed by 1 surgeon over the past 22 years. All but 3 of these procedures were performed open. Weight loss DISCUSSION failure was the indication for 151 of these, and complica- Although bariatric surgery can result in durable and sig- tions from the primary procedure were the indication for nificant weight loss, throughout its approximate 50-year theother64.Researchersfoundmajorperioperativecom- Figure1.Endoscopybefore(a)andafter(b)plicationusingtheStomaphyX. 110 JSLS(2011)15:109–113 plications in 45 patients (21%): 15 leaks, 11 wound infec- Mostrecently,areview10oftheinitialUSexperienceusing tions, 3 pulmonary embolisms, and 16 miscellaneous, in- the StomaphyX device to decrease gastric pouch size in cluding 3 deaths (1.4%). Complications were more patients undergoing RYBG concluded that endoluminal frequent,occurring36.9%ofthetimeinpatientswhohad revision using the StomaphyX may offer a safe and effec- had primary procedures performed by other surgeons, tivealternativetorevisionalbariatricsurgery.Theauthors versus 10.3% of patients on whom the surgeon had per- usedtheStomaphyXtoperformendoluminalreductionof formed the initial procedure. This led him to suggest that gastric pouches in 39 patients, over 90% of whom were surgeons should perform their initial revisions on their female with an average age of 47.8 years and an average own patients, rather than patients being referred from body mass index (BMI) of 39.8 kg/m2. At 2 weeks post- other surgeons.5 procedure, patients had lost an average of 3.8kg (7.4% excessbodyweightloss,EBWL).At6months,theremain- Becausethenumberofoperationsperformedfortreating ing patients being followed (n(cid:1)14) had lost 8.7kg (17% morbid obesity has increased almost 10-fold during the EBWL), and at 1 year, the 6 patients still being followed past decade, the number of patients requiring bariatric had lost 10kg (19.5% of EWBL). As with our patient, revisionforfailedweightlossorcomplicationhaspropor- symptoms improved, and no major complications oc- tionately increased also. While most of these are per- curred. formed open, some laparoscopic revisions performed on primary laparoscopic operations, show fewer wound Theabovestudiessuggestthatsomepostbariatriccompli- complications, less blood loss, and lower mortality.6 cations can be successfully addressed using endoscopic methods. Although several endoscopic examinations With the advent of natural orifice surgery, the armamen- were required, surgery and its associated complications tarium of possibilities to treat patients with failed primary were avoided. The procedures were tolerated well with bariatric procedures has further broadened. Those most minimal complications.4 likelytobenefitfromtheseprocedures,inadditiontothe morbidlyobese,includethecriticallyillandthoseathigh Our case report demonstrates that the StomaphyX is an- risk for surgery because of significant comorbidities.7 A otherdevicethatwarrantsconsiderationinpatientsfailing case series of 3 patients with chronic gastric leaks after to achieve satisfactory weight loss after RYGB. With fur- RYGB showed successful leak closure using a variety of ther study, and more long-term data, the efficacy of this endoscopicmethods.Theseincludedargonplasmacoag- procedure will be better elucidated. We have had diffi- ulation, hemoclips, fibrin glue, Polyflex stent placement, cultyrecruitingpatientsforStomaphyXendoluminalrevi- anddistalGJstenosisdilation.Inallpatients,leakclosure sion at our institution, because the procedure is not cov- was achieved and symptoms resolved completely. The ered by insurance, and the majority of our patients are onlycomplicationwasstentmigrationinonepatient,and Medicare or Medicaid insured. Despite this, we suggest it was retrieved endoscopically.4 In addition, a retrospec- that all postbariatric surgery patients with nonlife-threat- tive analysis8 looked at treating 19 patients after various eningcomplications,suchasdilatedgastricpouch,dilated bariatricprocedures(11withleaks,2withchronicfistulas, GJ anastomosis, and GG fistula be considered for endo- and 6 with strictures) with endoscopic stent placement. luminal repair using StomaphyX. Exclusion criteria for Oral feeding was started immediately in 79% of patients. endoluminalrevisionshouldincludethepresenceofperi- At mean follow-up of 3.6 months, 90% had symptomatic toneal signs or a free perforation and leak into the peri- improvement and 84% had resolution of leak or stricture. toneal space, both of which require emergent operative Healingoccurredatameanof33daysforleak,46daysfor repair. fistula,and7daysforstricture.Stentmigrationoccurredin 58% of stents placed, with 3 requiring surgical removal. The StomaphyX is a transoral device that places full- Another case series9 of 8 patients with significant weight thickness polypropylene SerosaFuse fasteners, creating regain and dilated GJ anastomosis after RYGB demon- gastric plications. These fasteners are nonabsorbable and strated the effectiveness of endoscopically placed sutures havestrengthequivalenttoa3-0suture.Throughtension- at the rim of the GJ anastomosis. When tightened, these free tissue approximation, they can be used to shrink sutures created tissue plications that reduced the anasto- stoma and gastric pouch sizes. There have been several moticsize.At4months,6ofthe8patientshadlostweight casestudiesinwhichthedevicewassuccessfullyusedfor (averageof10kg),andtheirBMIswentfromanaverageof pouch and anastomosis volume reduction. A case report 40.5 to 37.7. All endoscopic pouch reductions were done of2patientshasalsoshownStomaphyXtobeeffectivein without significant complication. treating gastric leaks after RYGB.3 We attempted to ad- JSLS(2011)15:109–113 111 UsingtheStomaphyXTMEndoplicatortoTreataGastricBypassComplication,deWolfeMAetal. dress our patient’s gastrogastric fistula using the device diet,whichwasadvancedtoaregulardietwithinthenext (Figure 2). couple of days. The morbidity and mortality of revision gastric bypass was avoided while the patient’s goal of One potential drawback of the device is that its overall moderate weight loss was achieved (Figure 3). structure and tip length somewhat limit the operator’s ability to manipulate it. As a result, we were unable to place fasteners in the location necessary to completely CONCLUSION closethegastrogastricfistula.However,thedilatedgastric pouch and GJ stoma were successfully reduced. As a The StomaphyX is an alternative for repair of some post- result, the restrictive portion of the patient’s initial proce- bariatric complications. In this case, although the gastro- dure was recreated. Her early satiety returned and she gastricfistularemainedpatent,boththepouchsizeandGJ began, and continues, to lose weight. In addition, the stoma were reduced, allowing the patient to again expe- procedurewasfast(lastingapproximatelyonehour),well rience early satiety. She, therefore, continues to lose tolerated, and without complication. The patient went weight by restrictive means. With the rapid advances of homethefollowingmorningaftertoleratingaclearliquid endoluminal technology and increasing experience with Figure2.(a)Tissueisdrawnintothechamber,and(b)plicationsarecreatedwhenthefastenersaredeployed. Figure3.StomaphyX(a)Deviceand(b)tip. 112 JSLS(2011)15:109–113 natural orifice surgery, the ability to successfully address 6. Brolin RE, Cody RP. Impact of technological advances on surgical problems through less-invasive means will con- complicationsofrevisionalbariatricoperations.JAmCollSurg. tinuetoimprove.11Futureresearchmustfocusnotonlyon 2008;206:1137–1144. the technological development of these devices, but also 7. Wagh MS, Thompson CC. Surgery insight: natural orifice on their long-term safety, efficacy, and durability, com- transluminal endoscopic surgery- an analysis of work to date. paredwithsurgicalalternatives,astheyareappliedinthe GastroenterolHepatol.2007;4:386–392. clinical setting. 8. Eubanks S, Edwards CA, Fearing NM, et al. Use of endo- scopic stents to treat anastomotic complications after bariatric References: surgery.JAmCollSurg.2008;206:935–938. 1. Santry HP, Gillen DL, Lauderdale DS. Trends in bariatric 9. Thompson CC, Slattery J, Bundga ME, Lautz DB. Peroral surgicalprocedures.JAMA.2005;294:1909–1917. endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients 2. Hallowell PT, Stellato TA, Yao DA, Robinson A, Schuster withweightgain.SurgEndosc.2006;20:1744–1748. MM,GrafKN.Shouldbariatricrevisionsbeavoidedsecondaryto increasedmorbidityandmortality?AmJSurg.2009;197:391–396. 10. Mikami D, Needleman B, Narula V, Durant J, Melvin WS. Naturalorificesurgery:initialUSexperienceutilizingtheStoma- 3. Overcash WT. Natural Orifice Surgery (NOS) using Stoma- phyXTM for repair of gastric leaks after bariatric revisions. Obes phyXTMdevicetoreducegastricpouchesafterRoux-en-Ygastric Surg.2008;18(7):882–885. bypass.SurgEndosc.2010;24:223–228. 4. MerrifieldBE,LautzD,ThompsonCC.Endoscopicrepairof 11. FloraED,WilsonTG,MartinIJ,O’RourkeNA,MaddernGJ. gastric leaks after Roux-en-Y gastric bypass: a less invasive A review of Natural Orifice Translumenal Endoscopic Surgery approach.GastrointestEndosc.2006;63(4):710–714. (NOTES) for intra-abdominal surgery: experimental models, techniques, and applicability to the clinical setting. Ann Surg. 5. BrolinRE,CodyRP.Weightlossoutcomeofrevisionalbari- 2008;247(4):583–602. atricoperationsvariesaccordingtotheprimaryprocedure.Ann Surg.2008;248(2):227–232. JSLS(2011)15:109–113 113