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Gastroesophageal Reflux in Laparoscopic Sleeve Gastrectomy; Hiatal Findings and Their Management influence outcome A. Lyon, S.C. Gibson, K. De-loyde, D. Martin

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S1550-7289(14)00328-1 http://dx.doi.org/10.1016/j.soard.2014.08.010 SOARD2086

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Surgery for Obesity and Related Diseases

Cite this article as: A. Lyon, S.C. Gibson, K. De-loyde, D. Martin, Gastroesophageal Reflux in Laparoscopic Sleeve Gastrectomy; Hiatal Findings and Their Management influence outcome, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/ j.soard.2014.08.010 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Gastroesophageal Reflux in Laparoscopic Sleeve Gastrectomy; Hiatal Findings and Their Management influence outcome Short title: GERD post LSG; hiatal management influences outcome

! A Lyon1, S C Gibson2,3, K De-loyde1, D Martin3,4,5

!

1.

Surgical Outcomes Research Centre, University of Sydney, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, Sydney, Australia

2.

Crosshouse Hospital, Kilmarnock Road, Crosshouse, Ayrshire, UK

3.

Concord Repatriation General Hospital

4.

Royal Prince Alfred Hospital

5.

Strathfield Private Hospital

! Corresponding author: David Martin, Suite 2, Strathfield Private Hospital, 3 Everton Rd Strathfield NSW 2035 Australia. [email protected],

! Telephone number +61297476166 Facsimile number +61297451299

Background Sleeve gastrectomy (SG) has become a definitive treatment for morbid obesity. There is conflicting evidence on the effects of SG on gastroesophageal reflux disease (GERD).

Objective The objective of this study was to assess whether taking an aggressive approach to managing hiatal weakness in patients undergoing SG results in an alteration in GERD symptoms.

Setting Tertiary public hospital and private hospital, Sydney, Australia

Methods Patients undergoing laparoscopic extended (beginning within 2cm from pylorus) SG were included. If evidence of weakness was present, an anterior hiatal dissection and tight suture repair was performed. If a hiatus hernia was present, formal repair was undertaken. Patients were questioned and scored on preoperative and postoperative reflux symptom frequency and severity, Proton pump inhibitor (PPI) usage, current weight and satisfaction.

Results A continuous cohort of 262 patients demonstrated a significant reduction in heartburn frequency (p=0.035) and severity (p=0.017). Moderate/severe preoperative reflux (Visick score 3 and 4) frequency improved whether there was a defect requiring repair or not (no repair p=0.02, hiatal suture p=0.001, hiatus hernia repair p 36 months. Mean excess weight loss percentage (EWL) at 12, 24 and 36 months, with follow-up numbers in brackets, was 80.3% (145/233), 80% (62/150) and 81.8% (16/50) respectively.

Demographics by hiatus group Patient demographics by hiatus group are shown in Table 2. Patients with hiatus hernias were older (p = 0.001) and had lower BMIs (p = 0.001) (Table 2).

Clinical Features Across the entire cohort reflux frequency and severity fell significantly pre- to postoperatively (p = 0.035 and p = 0.017 respectively) (Table 3a). Although mean scores fell, there was no significant difference in pre- and post-operative PPI or Visick scores for the entire cohort.

Hiatus subgroups When patients were split up by hiatal findings at surgery, for all clinical outcomes, there was a statistically significant difference pre-surgery between hiatus groups with those with increasing hiatal defects having more severe reflux (Table 3b). Following surgery, this difference in clinical outcomes between hiatus groups was no longer present (Table 3b).

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Effect of Hiatal Intervention on Reflux Frequency Figures 2a and 2b show pre and post operate reflux frequency and severity scores between hiatus group. Within the HH repair group there was evidence of a significant decrease in reflux frequency scores pre and postoperatively (p = 0.030), with a similar significant reduction in scores for the suture group (p = 0.033) (Fig. 2a). The nil intervention patients demonstrated an increase in reflux frequency pre to postoperatively however this was not statistically significant (p = 0.375) (Fig. 2a).

Effect of Hiatal Intervention on Reflux Severity HH repair patients showed a significant decrease in reflux severity scores pre and postoperatively (p = 0.048). However for suture and nil intervention patients there was no significant difference in reflux severity scores pre and postoperatively (p = 0.061 and p= 0.703 respectively) (Fig. 2b).

Change Scores by Hiatus group Change scores (pre to post- surgery) for each clinical outcome between hiatus group are shown in Table 4. There was a statistically significant difference in reflux frequency (p = 0.036) and severity (p = 0.030) change scores between hiatus group; patients from the nil hiatus group saw an increase in clinical outcomes scores pre to post surgery (i.e. increased reflux symptoms), while patients in the suture and HH repair groups saw a decrease in clinical outcome scores (i.e. decreased reflux symptoms). There was no statistically significant difference in Visick or PPI change scores between hiatus groups (Table 4).

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Changes in GERD by Pre-operative Reflux Status (pre-op Visick Score) Figure 3a shows changes in reflux severity symptoms by pre-operative Visick status. For patients with moderate or severe pre-op reflux (Visick 3 and 4) there was a significant and clinically valid decrease in both reflux frequency (p < 0.001) and severity (p < 0.001), pre to post operatively whereas those with none to mild pre-op reflux (Visick score 1 and 2) had a statistically significant, but clinically mild, increase in reflux frequency (p = 0.046) and severity (p = 0.043) pre to post operatively.

For patients with moderate to severe pre-operative GERD (Visick score 3 and 4) all patients, regardless of hiatus management, showed a significant decrease in both reflux frequency (Nil: p = 0.005, Suture: p < 0.001 and HH repair: p < 0.001) and severity. In patients with minimal preoperative reflux (pre-op Visick 1 and 2) there was a significant increase in reflux frequency scores for patients with no hiatal suture pre to postoperatively (p = 0.005), but no significant difference for those who underwent suture or HH repair. A similar effect was seen in severity scores, with the nil intervention group displaying an increase in symptoms postoperatively (p = 0.029) (Fig. 3b).

PPI Usage Although the cohort as a whole had no significant change in PPI usage pre to posoperatively, Table 5 demonstrates that the subgroup of pre-op Visick score 3 and 4 patients had a reduced median PPI usage from daily to rarely with surgery (p < 0.001). The group of pre-op Visick score 1 and 2 patients meanwhile increased mean PPI usage p < 0.001) though the limited clinical relevance was underscored by the fact that median usage did not change from never from pre to post-operatively (Table 5).

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Outcomes in Time from Surgery Cohorts Post-operative Visick score changed for patient cohorts as divided by time from surgery with a suggestion of increased reflux in patient groups with longer post-operative follow-up (Fig. 4). The proportion of patients with no reflux (Visick score 1) declined over increasing periods of follow-up post surgery (67% at < 12 months after surgery, compared to 50% > 36 months following surgery). Prior to surgery 12% of patients reported severe reflux (Visick score 4) with 1% at < 12 months, 7% at 12-24 months, 6.5% at 24-36 months, and 17% more then 3 years post surgery though the latter represented only 3 patients out of 18.

Changes in surgical technique over time may have also theoretically contributed to this effect with the infrequent use of omental gastropexy sutures in the patients in the >36 month cohort, as opposed to the evolvement of routine placement of 3 to 5 figure of 8 sutures from stomach to omentum in the more recent patient cohorts. These sutures potentially may reduced conduit torsion, subsequent obstruction and possible reflux. As aforementioned in methods, this was

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.

Satisfaction with Surgery Satisfaction rates with surgery were high with 94.7% of patients either satisfied or highly satisfied with their surgery, while 94.1% of patients reported an improvement in their health since having the surgery. Neither surgery satisfaction nor health since surgery were significantly associated with the amount of time between surgery and when the questionnaire was completed (p = 0.134 and p = 0.906 respectively). 96.7% of patients said they would recommend the surgery to others.

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DISCUSSION

Reflux outcomes post LSG are variable6,10,11 with the natural history of GERD following the procedure unclear. This may relate to the variable application in the type and frequency of hiatal repair performed during the procedure. This study was limited by data collection methods which involved retrospective telephone questionnaire which is subject to recall bias, plus objective measurement with pH assessment or manometry were not obtained within the study. However, our results demonstrated a low threshold for thorough phreno-esophageal dissection and tight repair of any hiatal defect, show an overall significant reduction in reflux frequency and severity. Subgroup analysis of hiatal intervention, found significantly higher respective preoperative reflux frequency and severity scores in the hiatus hernia repair group compared with the suture and no intervention groups. Post-operatively reflux symptoms between the three groups however became comparable, suggesting that this type of hiatal intervention contributed to reduced post-operative symptoms of GERD.

Patients with moderate/severe pre-op reflux (who may be precluded from LSG in some centers) represented 22% of patients in this study with 79% undergoing some form of hiatus repair. On subgroup analysis by hiatal intervention, all of these moderate/severe patients with GERD had a significant improvement in reflux symptoms as well as PPI use, with surgery, regardless of hiatal intervention so that even those who had no hiatal intervention demonstrated a significant benefit. This reflects that the pathophysiology of reflux in obesity patients, particularly those post-LSG is clearly multifactorial and it is probable that a combination of factors including weight loss, and changes in gastric physiology and anatomy that contribute to these patients‟ improvement in GERD. It should not imply however that those

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patients with a hiatal defect should be left without hiatal repair, as our results are based on a very low threshold for tight repair.

Patients with no or minimal preoperative reflux demonstrated a statistical but clinically mild increase in reflux symptoms and PPI use post-op operatively. On subgroup analysis, the statistical increase was only relevant for the group that underwent no hiatal intervention. With stratification using pre-operative Visick score and hiatal intervention the sample size was too small to further analyze with respect to different time groupings post-operatively. However it may be that with longer term analysis those patients with no hiatal intervention will have further deterioration in their reflux symptoms.

Despite small patient numbers at longer term follow up and changes in technique, in particular the use of gastropexy suture, our data supports the possibility that reflux may increase over the long term post surgery consistent with the limited literature available.4. In the single paper, Himpens et al. postulated that late reflux may be associated with formation of a neofundus, and it is possible that improvements in technique, including gastropexy and modification of incisura stapling technique to avoid stricture, as well as avoiding leaving excess fundus, coupled with a low threshold for tight hiatus repair, may reduce this late onset of GERD symptoms.

Conclusion

With extensive analysis of both pre and postoperative symptoms and hiatal findings, this study demonstrates that LSG, incorporating an aggressive approach to the management of hiatal laxity, improves reflux symptoms postoperatively in intermediate follow-up and

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achieves high patient satisfaction. Using this approach, gastro-esophageal reflux need not be a contraindication to LSG.

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REFERENCES 1)

Bodjalian A, Langer F B, Shakeri-Leidenmuhler S, et al. Sleeve gastrectomy as sole and definitive bariatric procedure: 5 year results for weight loss and ghrelin. Obes Surg 2010;20:535-40.

2)

Roa PE, Kaidar-Person O, Pinto D, et al. Laparoscopic sleeve gastrectomy as treatment for morbid obesity: technique and short-term outcome. Obes Surg. 2006;16:1323–6.

3)

Himpens J, Dapri G, Cadiere GB. A prospective randomised study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg 2006;16:1450-6.

4)

Himpens J, Dobbeleir J, Peeters G. Long-term Results of Laparoscopic Sleeve Gastrectomy for Obesity. Ann Surg 2010;252:319-24.

5)

Tai CM, Huang CK, Lee YC, Chang CY, Lee CT, Lin JT. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc 2013;27:1260-6.

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Chiu S, Birch DW, Shi X, Sharma AM, Karmali S. Effect of sleeve gastrectomy in gastroesophageal reflux disease: a systematic review. Surg Obes Rel Dis 2011;7:510-5.

7)

Lazoura O, Zacharoulis D, Triantafyllidis G, et al. Symptoms of gastroesophageal reflux following laparoscopic sleeve gastrectom are related to the final shape of the sleeve as depicted by radiology. Obes Surg 2011;21:295-9.

8)

Daes J, Jimenez ME, Said n, Daza JC, Dennis R. Laparoscopic sleeve gastrectomy: symptoms of gastroesophageal reflux can be reduced by changes in surgical technique. Obes Surg 2012;22:1874-9.

9)

Eslick GD, Talley NJ. Gastroesophageal reflux disease (GERD): Risk factors, and impact on quality of life – a population-based study. J Clin Gastroenterol 2009;43:111-7.

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10) Akkary E, Duffy A, Bell R. Deciphering the sleeve: technique, indications, efficacy, and safety of sleeve gastrectomy. Obes Surg 2008;18:1323-9. 11) Rubin M, Yehoshua R T, Stein M, et al. Laparoscopic sleeve gastrectomy with minimal morbidity early results in 120 morbidly obese patients. Obes Surg 2008;18:1567-70. 12) Csendes A, Burdiles P, Korn O, Braghetto I, Huertes C, Rojas J.

Brit J Surg

2000;83:289-97. 13) Rijnhart-de jong HG, Draaisma WA, Smout AJPM, Broeders IAMJ, Gooszen HG. The Visick score: a good measure for the overall effect of antireflux surgery? Scand J Gastroenterol 2008;43:787-93. 14) Friedenberg FK, Xanthopoulos M, Foster GD, Richter JE. The association between gastroesophageal reflux disease and obesity. Am J Gastroenterol 2008;103:2111-22. 15) Nilsson M, Johnsen R, Weimin Ye, Hveem K, Lagergren J. Obesity and estrogen as risk factors for gastroesophageal reflux symptoms. JAMA 2003;290:66-72. 16) Stene-Larsen G, Weberg R, Froyshov Larsen I, Bjortuft O, Hoel B, Berstad A. Relationship of overweight to hiatus hernia and reflux oesophagitis. Scand J Gastroenterol 1988; 23: 427–32.

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Figure 1a Exposure of the hiatus





Figure 1b Suture repair of the hiatus





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Figure 2a: Change in reflux frequency scores pre and postoperatively (repeated measures) for patients undergoing different hiatal management



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Figure 2b: Reflux severity scores pre and postoperatively (repeated measures)





Figure 3a. Reflux severity scores by pre surgery Visick score pre to post operatively (repeated measures)





Figure 3b. Reflux severity scores by hiatus group and pre surgery Visick score (repeated measures)



Figure 4: Visick score by time from surgery. (n)



Table 1 Symptoms Scoring System Variable

1

2

3

4

5

6

Frequency

None

Gastroesophageal reflux in laparoscopic sleeve gastrectomy: hiatal findings and their management influence outcome.

Sleeve gastrectomy (SG) has become a definitive treatment for morbid obesity. There is conflicting evidence on the effects of SG on gastroesophageal r...
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