A prospective study of gastro-oesophageal reflux disease symptoms and quality of life 1-year post-laparoscopic sleeve gastrectomy.

INTRODUCTION: There are concerns that laparoscopic sleeve gastrectomy (LSG) can cause severe gastro-oesophageal reflux disease (GORD). The aim of this study was to assess GORD symptoms and quality of life following LSG.
METHODS: A prospective study of patients undergoing LSG (2014-2016) was performed with follow-up by DeMeester Reflux/Regurgitation Score, Bariatric Quality of Life Index (BQLI) and Bariatric Analysis and Reporting Outcome System (BAROS) Score pre-operatively, 6 months and 1-year post-operatively.
RESULTS: Twenty-two patients were studied. Mean modified DeMeester Reflux/Regurgitation Score improved from 2.25 (±0.67) pre-operatively to 0.81 (±0.25) at 12 months (P = 0.04). At 12 months, two patients had symptomatic reflux, but overall satisfaction score was unaffected. Mean BQLI Score underwent a non-significant improvement at 12 months. BAROS Score showed all patients to have excellent (n = 19) or very good (n = 3) results (12 months).
CONCLUSION: GORD symptoms improve for most patients' 1-year post-operatively. A small proportion of patients will develop troublesome GORD, but overall satisfaction remains high.

INTRODUCTION

Laparoscopic sleeve gastrectomy (LSG) is an accepted surgical treatment for morbid obesity. Since becoming a stand-alone procedure in 2008, it continues to grow in popularity across the world. LSG has been shown to have significant improvements in patient weight and improvements in co-morbidities. Concerns exist that LSG may worsen or provoke gastro-oesophageal reflux disease (GORD).[12] This also has been a concern for other restrictive bariatric procedures including laparoscopic-adjustable gastric banding.[12] A systemic review and meta-analysis suggest paradoxical outcomes for GORD in patients after LSG.[1] Although weight loss often alleviates GORD symptoms through reduced intra-abdominal pressure, the potential for decreased gastric emptying and increased intraluminal pressure may lead to GORD. This may partially explain the heterogeneous reported results between and within studies.[12] The aim of this pilot study was to assess patient-reported outcomes of GORD symptoms and quality of life for 1-year post-LSG.

METHODS

A prospective pilot study of patients undergoing LSG between 2014 and 2016 was undertaken. Patients were selected for surgery after successful completion of Tier 3 weight loss management including losing 5% of total body weight pre-operatively. In this practice, an exclusion for LSG was severe GORD. Endoscopy and pH/manometry were not carried out pre-operatively. The technique used for LSG involved mobilisation of the greater curve from the antrum to the angle of His and mobilisation of the posterior body of the stomach. Intra-operatively, the hiatus was closely inspected in all patients by clear exposure using the Nathanson retractor. Dissection of the overlying peritoneum was carried out as required.[2] If present a hiatus hernia was repaired using anterior 0 Ethibond sutures (Johnson and Johnson Medical, New Brunswick NJ, USA), the posterior hiatus was also inspected and repaired as required. If no hiatal hernia was present, the phreno-oesophageal ligament was preserved. A stapled sleeve resection was subsequently performed over a 34F bougie. The staple line was oversewn with 2/0 polydioxanone in areas of serosal split/staple line bleeding if required.[2]

Patients who agreed to the study were followed up clinically and completed a modified DeMeester Reflux/Regurgitation Score[3] as part of the Adelaide Reflux Questionnaire,[4] the Bariatric Analysis and Reporting Outcome System (BAROS) Score[5] and the Bariatric Quality of Life Index (BQLI)[6] Score pre-operatively, at 6 months and 1-year post-operatively. The BQLI Score was subdivided into medical questions (n = 23) and functional, social and quality of life questions (n = 14). This was to assess whether changes in the quality of life were due to changes in symptoms and medical issues or social functioning. Patients were asked about overall satisfaction with the result of surgery at 1-year post-operatively. Questionnaires were completed by patients, with trained personnel on hand to offer one-to-one assistance. Statistical analysis was performed using IBM SPSS statistics (NY, USA). Statistics analysis was performed using paired t-tests.

RESULTS

Twenty-six patients underwent LSG during the study period. Four patients withdrew from the study: one for mental health reasons, one because of geographical relocation and two withdrew consent. Twenty-two patients with a mean age of 51 years (range 32–72) were studied. Nineteen were female. There were no mortalities and no significant post-operative complications. Two of the 22 patients had incidental hiatal herniae detected and repaired.

Surgical outcomes

Percentage total weight loss was 18.0% ± 6.0 (6 months) and 20.3% ± 7.9 (1 year). 15/22 (68%) were on antihypertensives pre-operatively but only 10/22 (45%) at 12 months (P = 0.012). 18/22 (82%) were diabetic at pre-operative assessment. 13/22 (59%) were on reduced medication at 12 months. None had complete resolution of their diabetes.

Overall satisfaction with sleeve gastrectomy

All 22 patients were satisfied with the operation at 1 year and would recommend the operation. Mean satisfaction levels were 9.55 ± 0.89 (10 = extremely satisfied, 0 = extremely dissatisfied).

Quality of life

There was an overall statistically significant improvement in symptoms and an excellent or very good outcome on BAROS over the 1st year post-LSG.

Gastro-oesophageal reflux disease symptoms

No patients had symptomatic reflux pre-operatively. Two patients had incidental hiatal herniae detected and repaired and neither of these reported GORD symptoms at any point. There was a non-significant increase in the mean modified DeMeester Reflux/Regurgitation Scores pre-operatively (2.25 ± 0.67) and at 6 months post-operatively (2.38 ± 0.59). Scores subsequently decreased dramatically by 12-month post-operatively to 0.81 ± 0.25 (P = 0.04). This was because two patients reported symptomatic reflux at 12 months: one developed de novo symptoms at 6 months, the other developed de novo GORD between 6 and 12 months. All patients were routinely placed on a PPI for the first 3 months. 13/22 (59%) remained on a PPI after 1 year. PPI therapy used was lansoprazole 30 mg od (n = 6), lansoprazole 30 mg bd (n = 2), lansoprazole 30 mg prn (n = 3) and omeprazole 20 mg od (n = 2). Indications for continued PPI therapy were daily GORD partially controlled by PPI (n = 2), infrequent GORD occurring less than once per week and requiring prn PPI only (n = 3), upper abdominal pain with no GORD (n = 3), prophylactic cover for non-steroidal anti-inflammatories (n = 4) and prophylactic cover for intermittent steroid use for asthma (n = 1).

Dysphagia

Mean Adelaide Dysphagia Score[4] improved slightly from 7.41 ± 1.58 pre-operatively to 7.57 ± 2.25 at 6 months and further improved significantly to 8.23 ± 1.61 at 12 months (P = 0.02). 13/22 (59%) reported no swallowing difficulty at all (scoring 9) at 1 year.

Four patients reported difficulty swallowing at 1 year. Three of the four had no problems pre-operatively or at 6 months. One of the four had reported issues with swallowing pre-operatively and at 6 months. All four patients underwent barium swallows which showed no abnormality. One patient had a gastroscopy which revealed no abnormality.

Bariatric analysis and reporting outcome system

At 6 months, eight patients had excellent, 12 had very good and 2 good outcomes on BAROS, with a mean BAROS Score of 7.14 ± 1.8. At 12 months, these had improved to 19 excellent and 3 very good with a mean score of 8.14 ± 1.0. Subanalysis of the quality of life showed a statistically significant improvement over the post-operative first 6 months which was maintained at 12 months.

Overall mean BQLI Score underwent a non-significant improvement from 46.6 ± 7.8 pre-operatively to 48.5 ± 8.9 at 6 months and 49.62 ± 2.46 at 12-months post-operatively (P = 0.45). A subanalysis revealed a significant improvement in both the functional and self-confidence components at 12 months. The improvement in confidence occurred after the 6-month period. There was a highly significant improvement in the QOL component at both 6 and 12 months [Table 1].

Table 1

Summary of symptom and quality of life questionnaire scores

	Pre-operative	6 months	1 year
Modified DeMeester	2.25±0.67	2.38±0.59	0.81±0.25 (P=0.04)
Adelaide Dysphagia Score	7.41±1.58	7.57±2.25	8.23±1.61 (P=0.02)
BAROS QOL subanalysis	0.7±0.25	2.0±0.63 (P=0.03)	2.1±0.34 (P=0.01)
BQLI	46.6±7.8	48.5±8.9	48.6±10.1
BQLI subsets
Symptoms/medical	7.16±0.9	6.91±0.96	6.39±0.63
Functional/social/QOL	39.52±7.68	41.39±9.06	45.25±10.36 (P=0.03)
Quality of life	2.6±0.8	4.1±0.7 (P<0.01)	4.4±0.9 (P<0.01)
Self confidence	2.8±1.0	3.1±0.7 (P=0.37)	4.3±0.7 (P<0.01)

BAROS: Bariatric Analysis and Reporting Outcome System, BQLI: Bariatric Quality of Life Index, QOL: Quality of life

Gastro-oesophageal reflux disease patients (n = 2)

Both patients with GORD at 1 year were satisfied with the operation at 1 year and would recommend the operation. Satisfaction levels, determined by a patient-reported question and score, were high for both. At the time of surgery, neither patient had an incidental hiatal hernia. A summary of characteristics is shown in Table 2.

Table 2

Summary of outcomes of patients with gastro-oesophageal reflux disease

	Patient 1			Patient 2
Satisfaction score	8/10			10/10
Percentage total weight loss	15			20
Resolution of co-morbidities	Yes (hypertension)			N/A
PPI use	Yes			Yes
Further investigations	Nil			Barium swallow and OGD (normal)
	Pre-operative	6 months	12 months	Pre-operative	6 months	12 months
DeMeester	0	2	1	9	12	12
BAROS	X	9	9	X	6	9
BQLI	47	61	40	44	38	46
BQLI subsets
Symptoms/medical	8.5	9	9	8.5	6.5	5.5
Functional	30	62	42	44	38	46
QOL	2	4	5	2	5	2
Self-confidence	2	2	5	5	2	3

BAROS: Bariatric Analysis and Reporting Outcome System, BQLI: Bariatric Quality of Life Index, QOL: Quality of life, N/A: Not available, PPI: Proton-pump inhibitor, OGD: Oesophago-gastroduodenoscopy

DISCUSSION

The main findings of this study are that LSG leads to a statistically significant improvement in GORD symptoms at 12-month post-operatively for most patients. This occurs after an initial increase in GORD symptoms over the first 6 months. A small proportion of patients develop troublesome GORD symptoms post-operatively, but some of these will resolve spontaneously. Patients reported an improvement in the quality of life symptoms which was more marked at 12 months and less evident at 6 months post-operatively. Nevertheless, the presence of GORD symptoms does not necessarily reduce patient-reported satisfaction with surgery.

The main weaknesses of the study were the small numbers and lack of oesophageal physiology measurements. However, this was designed as a pilot study to assess changes in GORD, quality of life and satisfaction over the 1st year. Repeated oesophageal physiology studies assessments have been shown to be unpopular, add extra expense and would not alter patient management.[27]

The main strengths of the study are that it was a prospective study providing a detailed analysis of GORD symptoms, quality of life and satisfaction using validated questionnaires.[356]

Techniques to prevent GORD post-LSG include excluding patients with severe GORD, preserving the incisura angle and the phreno-oesophageal ligaments and repairing any hiatal herniae.[28] However, there is no general consensus.[9] Both our patients who had a hiatal hernia repair did not develop symptomatic GORD; this is in keeping with a recently published study.[2] In this study 10% of patients had a hiatus hernia detected intra-operatively, which were repaired. This is similar to a recent study, in which 4% had a hiatal hernia but up to 50% had laxity of the hiatus meriting repair.[2]

The effects of LSG on GORD are heterogeneous amongst study populations with new-onset GORD varying between 0% and 35% in published studies with variable follow-up (1–60 months). We have shown that GORD may develop after 6 months and also may resolve over the 1st year. Interestingly, in keeping with the findings of a recent study, the present study showed GORD symptoms to increase slightly over the first 6 months in most patients before significantly improving by 1 year. These data are useful as patients can be made aware to expect a transient increase in symptoms over the first 6 months that is likely to settle. This may be due to the initial increased sleeve pressure that subsequently reduces with time. We have also shown that GORD symptoms do not necessarily affect overall satisfaction with surgery.[1011] A recent randomised controlled trial has shown GORD symptoms to be worse after LSG than gastric bypass, but overall quality of life to be similar, questioning the significance of GORD symptoms for some patients. Our findings are similar with regard to high satisfaction levels and reported quality of life despite the development of GORD symptoms.[10] In our study, most patients post-LSG has a significant improvement in self-reported GORD symptoms. One of the two patients who developed GORD from our study did so after 6 months and a different patient had a resolution of GORD symptoms after that time.

Almost 60% of patients remained on PPI therapy at 1 year. Although 60% persisted on PPI only 2/13 patients were on this for daily GORD partially controlled by PPI, 3/13 patients required infrequent PPI use for occasional GORD episodes. The other 8/13 patients were on PPI therapy, continued by their general practitioner for non-GORD-related reasons – dyspeptic symptoms (n = 3) and prophylaxis against gastric ulceration from non-steroidal therapy or intermittent steroid use (n = 5). Previous studies have shown heterogeneity in the use of PPI post-sleeve but tend to show an increase in their use.[1] The effect of PPI post-sleeve on symptoms in the current study remains unknown.[2]

Patient-reported outcomes and quality of life assessments have been established as end-point outcomes from surgery.[10] Our study showed that 1 year after LSG all patient have either an excellent (n = 19) or very good (n = 3) result on BAROS scoring. Subanalysis showed the improvements in patient-reported quality of life to occur in the first 6 months and this was maintained at 12 months. The overall BQLI Score showed a non-significant increase over 12 months. On further analysis, this did not reach significance due to the development of osteoarthritis in two patients and a further patient increasing analgesia requirements. Subanalysis revealed an improvement in the self-reported quality of life outcomes over the 12 months. Patient-reported quality of life improved over the first 6 months and self-confidence by the 12-month period. Our subanalysis reveals improved psychological well-being and social functioning over the 1-year post-LSG.

CONCLUSION

LSG improves the quality of life for most patients by 1 year following the operation. Patient-reported GORD symptoms for most patients improved over the 1st year. This occurs after a transient increase in GORD symptoms at 6 months. A small proportion of patients may develop troublesome GORD post-operatively, but this does not affect overall satisfaction with surgery.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.