ABSTRACT surgeon. Data regarding demographics, calibrating devices and

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                                                       ABSTRACT                 Introduction: Sleeve gastrectomy (SG) is one of the most commonprocedures performed for weight loss. Many seek the “perfect sleeve” with the notion that the type ofcalibrating device affects sleeve shape, and this in turn will affect outcomesand complications.  Two major concernsafter SG are amount of weight loss and acid reflux.

Our aim was to determine if the various calibration methodscould impact sleeve shape and thereby allow for better outcomes of weight lossand reflux. Methods: Aretrospective chart review was performed of 210 patients who underwent SG andhad postoperative upper gastrointestinal study (UGI) from 2011 to 2015 in asingle center by a single (fellowship-trained) bariatric surgeon. Dataregarding demographics, calibrating devices and clinical outcomes at 1 year(weight loss and de-novo acid reflux) were collected.  UGIs were reviewed by two radiologistsblinded to the clinical outcomes. Sleeve shape was classified according to apreviously described classification as tubular, dumbbell, upper pouch or lowerpouch. The types of calibrating devices used to guide the sleeve sizeintra-operatively, were endoscopy, large-bore orogastric tube and fenestratedsuction tube. Results:Onehundred and ninety-nine patients met inclusion criteria (11 had no esophagram).Demographics revealed age 45.

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76 +10.6 years, BMI 47+8.6 kg/m2,and 82% female. Calibration devices used were endoscopic guidance (7.6%), largebore orogastric tube (41.4%), and fenestrated suction tube (50.5%). Sleeveshape was reported as 32.

6% tubular, 20.6 % dumbbell, 39.2% lower pouch and7.

5% upper pouch (100% interrater reliability). No correlation seen with typeof calibration used. 62.0% of patients had >50% excess weight loss at 1 year.

 23% of patientsremained on PPI at 1 year (of which 43.3% did not have reflux preoperatively).  The lower pouch shape showed a trend towardless reflux and more weight loss.  Conclusion:Thisstudy showed no clear association between uniformity of sleeve shape and thetype of calibration device used.

  Thestudy showed a trend toward decreased reflux and improved weight loss with thelower pouch shape, regardless of calibration device.  Keywords: sleevegastrectomy, shape, reflux, weight loss Introduction:        Obesity is a worldwide public healthconcern, as obesity has doubled since 1980 with 1.5 billion adults consideredobese in 2008 1. In the United States, 34 percent of adults over 20years of age are overweight, 34 percent are obese, and 6 percent are extremelyobese2. Obesity is directly associated with increased riskof diabetes, hypertension and other chronic diseases, and places a huge burdenon public health.

     Over the past 20 years, bariatric surgeryhas become a well-accepted solution to this public health concern. Although thegastric bypass used to be the most commonly performed procedure for weightloss, now the sleeve gastrectomy (SG) is one of the most commonly performedprocedures in the United States and even worldwide. The sleeve’s safety andlong term weight loss results in multiple studies have been widely proven. Inaddition, surgeons find the procedure to be technically simpler than thegastric bypass with a shorter operative time. 3-6  That being said, there is widevariability in technique of sleeve creation.

7     As surgeons have gained experience withthe sleeve, two aspects have been identified as primary concerns for thesurgeon: effectiveness of weight loss and avoidance of postoperativereflux.  Reflux has been a surprisingunintended consequence of sleeve gastrectomy in several studies.8 .  The reasonfor this is unclear.  Possibilitiesinclude increased pressure within the lumen of the remaining stomach,increasing the susceptibility of acid reflux 9.  Other studiessuggest that disruption to angle of His and resection of sling fibers at thehiatus may play a role in the creation of reflux.10 Thus many studies have been done to further evaluatehow to minimize the reflux seen after sleeve while maximizing weight loss.11            This brings one to the notion of theperfect sleeve.

Few studies have looked at the final sleeve shape as it relatesto outcomes after weight loss surgery. There has been suggestion that the shapemay affect reflux. 12-13 Is there an ideal shape to the sleeve that optimizes outcomes?  Also does the calibration device impact thefinal shape of sleeve attained? The purpose of this study is to determine ifthe calibration device impacts the uniformity of the sleeve that is created.  Also, we sought to determine whether the finalshape of the sleeve impacts persistent postoperative reflux and excess weightloss (EWL) after the procedure.  Materials and Methods:     A retrospective chart review was performedof 210 patients who underwent SG from January 2011 to September 2015 in asingle center by a single surgeon who is board certified and didfellowship-trained bariatric and endoscopic surgeon, and has been practicingbariatric surgery for the last ten years, performing around 200 differentbariatric procedures per year in a center of excellence in bariatric surgerythat is accredited by the MBSAQIP of the American College of surgeons..  All patientsunderwent a postoperative upper gastrointestinal study (UGI) with water solublecontrast on the first day after surgery. Those who did not have a study wereexcluded.

As the studywas a retrospective chart review we did not calculate required sample size. Data regarding demographics, calibrating devices, andclinical outcome at 1 year were collected. (Table 1) Postoperative weight lossdata were expressed as % of excess weight loss (EWL) (recommended assessmenttool by the American Society of Metabolic and Bariatric Surgery) 14.  Stringentdefinitions were used to define de novo reflux and “successful” weight loss. De-novoreflux, was defined as patients who remained on proton pump inhibitors(PPI) at the one year postoperatively but had no prior history of reflux or PPIuse prior to weight loss surgery.  EWLwas considered successful in patients who lost >50% of EWL at the end of thefirst year. This study was approved by theInstitutional Review Board of our center (IRB No. 12-15-34).

Proceduredescription Only patients who underwent primary laparoscopicsleeve gastrectomy were included. The technique was standardized. A 4-trocarapproach (one 15mm, one 12mm and two 5mm) was used. The dissection startedalong the greater curvature of the stomach, using ultrasonic energy to takedown the short gastric arteries. The fundus is fully mobilized and the leftcrus is exposed. The types of calibrating devices used to guide the sleeve sizeintra-operatively were: endoscope (approximately 32 French), large boreorogastric tube (32-36 French) and fenestrated suction tube (36 French). Thechoice of calibration tube used was at the discretion of the surgeon as thepractice evolved.

  Stapler firing began 5cm proximal to the pylorus and care was taken to avoid narrowing at theincisura.  This staple line proceeded tothe angle of His. The calibration device was used as a guide for creation ofthe sleeve.  Bio-absorbablebuttressing material was used for staple line reinforcement. Endoscopy wasperformed intraoperatively after the sleeve was completed to ensure hemostasisand check for leaks. Drains were used rarely. The resected stomach was removedthrough the 15mm trocar site, followed by closure of fascia and skin.

Water-solublecontrast upper gastrointestinal series (UGI) was performed for every single caseon postoperative day 1 (POD 1) to check for leaks and document the anatomy ofthe sleeve at time of creation. This test was usually done in two positions:flat and upright positions (60-degree plus). Patients ingested thewater-soluble contrast (Gastrografin), then fluoroscopic images were obtained,using frontal and oblique projections. Images are taken in a special magnifiedresolution. Patients are usually discharged later on POD 1.

 Sleeve shape evaluation      UGIs were reviewed by two radiologists,independently, who were blinded to the clinical outcomes. Sleeve shapes wereclassified according to a previously described classification as tubular (T-uniformtube shaped stomach), dumbbell (DB-stomach with dilated portions proximally anddistally and narrow in the middle), upper pouch (UP-proximal dilation of thesleeve) or lower pouch (LP-tubular upper portion of sleeve but retention of agood portion of antrum).12  (Figure 1) Analysis of the associationbetween sleeve shape category, calibration device, and clinical variables was performed. StatisticalAnalysisData were analyzed using SAS University Edition (SASInstitute Inc.

, Cary, NC, USA). Results are reported as mean or median ±standard deviation (SD) for continuous variables. Clinical differences amonggroups were determined by one- way ANOVA and t-test.  Comparisons weredetermined by Fisher’s exact test.

A P value <0.05 was consideredsignificant. In order to controlthe factors affecting outcomes we performed logistic regression analysis. Results             Of 210 patients, only 11 had noesophagram in the postoperative period. One hundred and ninety-nine patients wereincluded in the study.

The patients who competed 1 year of follow up were113/199 (57%). Demographics revealed mean age 45.76 +10.6 years and preoperative BMI 47+8.6 kg/m2. 82% of patientswere female.

The comorbidities were: obstructive sleep apnea (86%),hypertension (67%), dyslipidemia (53%), arthritis (56%), depression (32%),diabetes type 2 (29%), hypothyroidism (18%), cardiovascular diseases (15%) andbipolar disorder (2%).  (Table 1)         Sleeve shapes were reported as 32.6%tubular, 20.6 % dumbbell, 39.

2% lower pouch and 7.5% upper pouch (100%interrater reliability) by the radiologists. (Figure 2) Sleeve shape & calibrating device Calibrationdevices used were endoscopic guidance (7.6%), large bore orogastric tube (41.4%),and fenestrated suction tube (50.5%).

There was no relationship betweenresultant sleeve shape and type of calibrating device (P=0.395).  In a subgroup analysis, tubular (T) shapecompared to Non-T Shape (UP, LP, DB) did not show statistical associationbetween shape and calibrating device. However, T shape was reported morefrequently in cases where endoscopic guidance was used (endoscopic 46.7 %, large bore tube25.9% and fenestrated suction tube 36.

0%, P=0.11).(Table 2). Similarly, lower pouchshaped sleeves also showed no correlation with the calibration device ascompared to the other shapes, however was more frequently observed with thelarge bore and fenestrated suction tubes. In addition, none of the devices showed any more uniformity of theresultant sleeve than the others.

Sleeve shape & weight loss            The mean excess weight loss (EWL) at12 months was 60.3%. The reason we chose 1 year follow up in this study, thatmany studies recently suggested that the maximum EWL happens at 1 yearpost-operatively.

15-16 Regarding sleeveshape, the mean %EWL was 55.3% in tubular, 60.0% in dumbbell, 63.9% in lowerpouch, and 61.

7% in upper pouch shape group, respectively. There was no statistical difference between the shape ofthe sleeve and EWL (p=0.48), however the patients with a lower pouch showed atrend toward greater weight loss (Table 3). Sixty-two percent ofpatients who completed one year follow up had achieved successful weight loss(EWL>50% at 1 year).  We found nostatistically significant relationship between sleeve shape and EWL>50%(p=0.34), but the lower pouch showed a trend toward greater success. (Table 3)    The logistic regression analysis revealed that only age was associatedwith the outcome.

(Table 5)  Sleeve shape & reflux symptoms Twenty-threepercent of patients reported ongoing PPI usage at 1 year, of which 43.3% did nothave reflux preoperatively (defined as the de-novoreflux group). The sleeve shape did not show a clear association with thepresence of reflux or de-novo refluxsymptoms (p=0.

7), however, a trend was observed toward less de-novo acid reflux in patients with thelower pouch shape.Logistic regression did not reveal a clear association between the outcome andthe investigated factors. (Table 6)  Readmission rate was 1.8% (3/199), one case of leak, who wassimultaneously drained by laparoscopy and stented endoscopically.

One case ofpost-operative bleeding, and a case of pulmonary embolism those were managedconservatively.Discussion                 This study is one of the firstto look at the impact of calibration device on sleeve morphology, and theimpact of sleeve morphology on the outcomes of reflux and successful weightloss at 1 year postoperatively. In this study, three calibration devices wereused to assess the uniformity of the shape of the resultant sleeve and nodevice showed any consistent uniformity in the final sleeve shape. This finding echoes priorstudies where they also noted varying sleeve shapes were achieved despite usinga standard technique. 11,12 This suggests that surgeon technique orpatient factors may be involved in the final shape of the sleeve.

  When looking at trends, we noted a trendtoward a tubular shape was more likely with endoscopic guidance, while thelower pouch shape was more common when largebore and fenestrated suction tubes were used. In the other studies themost common shape was tubular. (Figure 3)                   At 12-month follow up, themean EWL was consistent with most prior studies.

What is notable is that of thepatients who achieved successful weigh loss at 1 year, 49% were from the lowerpouch group. Interestingly, in the first analysis of the MBASQIP database, itwas observed that the greater the distance from the pylorus, the initial stapleline was started, the more the weight loss.7 If we assume that goingfurther from pylorus will yield a lower pouch shape, this study may alsosuggest that lower pouch shape may have better weight loss results. Otherstudies looked at hunger scores with regard to sleeve morphology.  They noted the most hunger in the dumbbellshaped morphology. Retention of more antrum may affect gastric emptying orhunger that may then enhance weight loss. The satiety control was better in lower pouch group in comparison withother groups.11 They postulate that the dumbbell group had thegreatest capacity, especially with the retained fundus and this explained thegreater hunger.

                   The other important outcome notedin this study and prior studies is the incidence of reflux with regard tosleeve morphology. No statistically significant association could be associatedwith sleeve shape, however, patients with the lower pouch shape demonstrated aclear trend towards less de-novo refluxsymptoms. Other studies demonstrated a higher incidence of reflux (59%) but thefollow up was only 6 months and the definition of reflux was based on symptomscores.11,12 They also found that higher severity of reflux happenedin upper pouch group versus other groups and least reflux symptoms happened inlower pouch group. The retained fundus is clearly an undesirable outcome notedin all studies as it is associated with a higher incidence of reflux.             In another study conducted by Lazoura et al, 3 morphological sleeve patternswere noticed on UGI after SG, tubular 65.

9%, superior pouch in 25.9% andinferior pouch in 8.2%, they had higher incidence of early vomiting andregurgitation in the tubular shape.13  Our series also supports the tubular andupper pouch groups having the most reflux. The authors postulate that theincreased intragastric pressure in a tight tube, with impaired relaxation leadsto an increase in these symptoms.13Not only sleeve shape can affect reflux, but many other factors including;disrupting the sling fibers of the LES during SG, reduced gastric capacity withintact reflux and altering the anatomy of angle of His, have an important rolein developing reflux after SG. 8, 17-18We recognize that manystudies have been done suggesting improved or no change in reflux following thesleeve, however, these three studies looking at sleeve morphology alldemonstrate evidence of ongoing reflux after the sleeve. In addition, our studynotes the least reflux in the lower pouch group and this is similar to otherstudies.

11,12, One possible explanation is that in lower pouchgroup, when we preserve the antrum totally or near totally, we may allow for aproper gastric emptying mechanism, hence less reflux.                        So, based onthe findings of this study and prior studies, the authors conclude that thelower pouch shape is the most desired outcome. Prior studies have suggested the tubular shape is the most desiredoutcome. 11,12 All three of these studies looking at the tubularshape note a higher incidence of reflux with this shape.  These studies all support that the retainedfundus leads to more reflux and may increase the capacity of the stomachleading to more hunger.  Finally, theleast reflux and the most weight loss is seen in the lower pouch groups in thisand other studies. 11                    Thisstudy does have some limitations. First,the sample size was small which resulted in an inability to make steadfastconclusions due to lack of power.

  Sincethis was retrospective, a prior power analysis was not done prior todetermining the use of sizing device. Therefore, a clear distinction in theability to make a consistently shaped sleeve cannot be clearly associated withthe type of device based on this study.  Therewas 43% loss of follow up at one year, since many patients who come to ourcenter, are internationals or out of state. However, these data can be used forplanning future studies and definitely provide a basis for larger futurestudies. Larger numbers may have achieved greater statisticalsignificance. The lack of significance may also be related to the stringentdefinitions used for de-novo reflux and successful weight loss.Additionally, 43% of patients were lost to follow up at one year.

  Presumably those patients were doing wellwith their weight loss and did not have reflux that necessitated a return tothe physician.  Furthermore, theinterpretation of UGI studies may have been limited by the staticpictures.  However, the radiologists had100% interrater reliability suggesting this limitation was minimal. ConclusionThisis the first study to assess weight loss and de novo reflux at one yearpostoperatively with regards to the shape of the sleeve. Although it showed no clearassociation between the final sleeve shape and type of calibration device used,it demonstrated a trend toward less reflux and improved weight loss with alower pouch shape regardless of calibration device.  This suggests that surgeon technique andpatient factors may be more important than the type of calibration device.  Further studies to refine technique areneeded to achieve the best outcomes with regards to maximizing weight loss andminimizing reflux. Ethical statementAll procedures involving human participants wereperformed in accordance with the ethical standards of the institutional and/ornational research committee and with the 1964 Helsinki Declaration and itslater amendments or comparable ethical standards.

 Informed consent was obtained from all individualparticipants included in the study.   References:1.         Chan, J. C.

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