Beyond the Decade: Unveiling Long-Term Weight and Co-Morbidity Outcomes More Than 10 Years Post Laparoscopic Sleeve Gastrectomy

doi:10.21203/rs.3.rs-3332482/v1

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Research Article

Beyond the Decade: Unveiling Long-Term Weight and Co-Morbidity Outcomes More Than 10 Years Post Laparoscopic Sleeve Gastrectomy

https://doi.org/10.21203/rs.3.rs-3332482/v1

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Introduction

Despite its effectiveness, long-term outcomes of the safety and effectiveness of laparoscopic sleeve gastrectomy(LSG) for morbid obesity are still lacking.

Methods

We utilized phone interviews and hospital chart data for patients who underwent LSG, analyzing weight outcomes, comorbidities, and complications.

Results

The study included 2982 patients (72% female) with a maximum follow-up of 13 years. Mean pre-operative age and body mass index(BMI) were 34.7±11.3 years and 45.5±7.7 kg/m². The prevalence of obesity classes were as follows: Class I, 3.1%; Class II, 19.2%; and Class III, 75.9%. BMI at nadir was 32.35 Kg/m2 equating to a mean nadir excess weight loss(EWL) of 67.03%. Weight outcomes at 13 years post-LSG showed a mean BMI of 31.83 kg/m²and total weight loss(TWL) percentage of 31.43%. The highest excess weight loss and total weight loss were observed at 4 years and 18 months post-LSG, respectively. Weight loss outcomes varied according to pre-operative obesity class, with class I achieving the highest percentage EWL and class III observing the highest TWL at the end of one year. Weight regain occurred in 1.3% of the patient population, with class III experiencing the highest weight regain at 13 years. Significant reductions in comorbidities were observed, with a remission rate of 12.9% for type-1 DM. Complication rates were low, with 0.4% bleed, 0.5% leak, and 7.9% GERD.

Conclusion

LSG demonstrates sustained weight loss and comorbidity resolution, with low complication rates. The influence of initial obesity class on weight loss was significant only in the first 18 months post-LSG.

The long-term management of the obesity crisis has become one of the most important items on the health budgets of Western countries [1–3] given the chronic nature of the disease and the comorbidities associated with it. Bariatric surgery has been proven to be the most effective treatment modality for the management of morbid obesity, as it is shown to lead to satisfactory long-term weight loss and significant reduction in these related co-morbidities [4].

Laparoscopic sleeve gastrectomy (LSG) was initially described either as a first step procedure for the biliopancreatic diversion duodenal switch (BPD/DS) [5] or as a primary intervention for high-risk bariatric patients scheduled to undergo laparoscopic Roux-en-Y gastric bypass (LRYGB) [6]. However, over time, LSG has become the most frequently performed bariatric/metabolic procedure worldwide, largely attributed to it’s straightforward operative technique, absence of gastrointestinal anastomoses and foreign material required, resulting in minimal alteration of the patients anatomy, as well as proving successful short and mid-term weight loss outcomes, with low morbidity rates and having the ability to easily be converted to an alternate bariatric procedure [7–10]. However, despite its increasing popularity, a paucity of studies looking at long-term outcomes exist, restricting the assessment of the LSGs’ sustained effectiveness and safety [11], while the ones that do exist exhibit high incidences of weight regain [12, 13] and de-novo reflux or worsening of pre-existing gastroesophageal reflux disease [14, 15].

We herein present our long-term primary LSG results in terms of weight loss, remission of comorbidities, and complication and reoperations rates at a single institution with a maximum follow-up time of 13 years.

Patient Follow-Up

Patient follow-up was conducted via phone interviews evaluating long-term LSG outcomes supplemented by hospital chart data. Inclusion criteria included patients who underwent primary LSG at our center. All patients met the standard inclusion criteria for bariatric-metabolic surgery (i.e., body mass index [BMI] ≥ 40.0 or ≥ 35.0 kg/m2 with weight-associated medical conditions) [16].

A telephone interview was conducted pertaining of detailed questions regarding weight outcomes, coexisting obesity-related conditions (hypertension, type 2 diabetes mellitus (T2DM), obstructive sleep apnea), post-operative complications (bleed, leak, gastroesophageal reflux disease (GERD)) and the need to undergo abdominoplasty post-LSG and/or a secondary bariatric procedure.

Pre-Operative Evaluation

A comprehensive laboratory workout was performed on all patients pre-operatively and included a complete blood count, thyroid function tests, renal and liver profiles, coagulation profile, and upper endoscopy to evaluate for GERD, hiatal hernia and pathologic examinations, along with Helicobacter pylori CLO test. These procedures were followed for all patients prior to undergoing LSG.

LSG Procedure Technique

The LSG procedure was performed using five laparoscopic ports in a standard split-leg French position. Devascularization of the greater curvature of the stomach was done starting from 4 to 6 cm from the pylorus and up to the angle of His before a 36-Fr calibrating bougie was passed through the stomach to the duodenum. The sleeve was then performed with a linear laparoscopic stapler. The staple lines are sequentially fired along the bougie toward the angle of His and divide the fundus at a distance of .5 to 2 cm lateral to the esophagus. Finally, the bougie was pulled proximally and an assessment of leak was done by injection of 100 ml of methylene blue. No intra-abdominal drains were placed. If a hiatal hernia was observed intra-operatively, it was repaired during the SG procedure.

Venous thromboembolic prophylaxis was initiated within 12 hours of surgery and continued for 2 weeks [17]. A bariatric dietitian provided detailed dietary guidance during recovery [18]. Patients were instructed to attend routine follow-up appointments with their bariatric multidisciplinary team.

Definition of Co-morbidities – Diabetes

Diabetes was defined as either 1) Impaired glycaemia or impaired glucose tolerance 2) the need for insulin treatment 3) the need for oral antidiabetics (OAD) & insulin treatment or 4) the need for oral hypoglycemics.

Definition of Co-morbidities – GERD

Gastro-esophageal reflux disease was defined as patients that either where on: 1) Daily medication (H2 receptor antagonists (H2RA) or proton pump inhibitors (PPI)) 2) Intermittent medication or 3) Intermittent symptoms; with no need for medication. All patients undergoing a sleeve gastrectomy at our institution are evaluated for reflux pre-operatively. If the reflux is Grade A or lower, we would still perform a sleeve gastrectomy on the patients given that the likely etiology is due to obesity itself creating pressure on the abdomen. If grade B or lower reflux is detected, we perform further evaluation for the reflux and place the patients on a PPI regimen as previously described [19]. The patients are then re-evaluated for reflux and if it is resolved, the sleeve gastrectomy is then performed as planned. However, if the reflux is persistent, then a sleeve gastrectomy is not recommended, and the patients are offered a Roux-en-Y gastric bypass instead.

Definition of Co-morbidities – Hypertension (HTN)

Hypertension was defined as either: 1) Treated hypertension 2) Untreated hypertension.

Definition of Co-morbidities – Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea was defined according to in-home sleep apnea monitoring devices. Sleep assessments were performed for one night using the Nox T3 device. All sleep examinations were analyzed manually by the same registered polysomnographic technologist (RPSGT) according to the respiratory rules defined by the American Academy of Sleep Medicine [20]. Apneas were identified if there was a ≥ 90% drop in airflow for the duration of at least two breaths. Obstructive apneas were defined as apneas associated with respiratory effort throughout the entire period of the event.

Postoperative Evaluation

Patient follow-ups were conducted at 1, 3, 6 and 12 months post-operatively, and then yearly afterwards up until 13 years post initial LSG. Weight loss was expressed in terms of evolution of BMI, % excess weight loss (%EWL) and % total weight loss (%TWL). Patient loss-to-follow-up can be seen in Fig. 1.

Statistical Analysis

Statistical analysis of the data was carried out using SPSS software version 22. The significance of the difference between the two values was analyzed using a two-tailed unpaired Student’s t test. Kaplan-Meier freedom from event curves were utilized to examine bariatric-specific freedom from reoperation. For all data comparisons, statistical significance was defined as p < 0.05. %EWL was calculated using an ideal body weight equivalent to a BMI of 25 kg/m2.

Baseline Characteristics

Our study includes data collected from a total of 2982 patients that underwent laparoscopic sleeve gastrectomy as a primary procedure, of which 2147 (72%) were female. The patients age at the time of surgery was 34.69 years old (± 11.25), while their pre-operative weight was 122.66 Kg (± 24.60), corresponding to a BMI of 45.50 Kg/m² (± 7.73) (Table 1). 93 patients (3.1%) belonged to the Class 1 obesity group (BMI = 30–35 Kg/m²), 573 patients (19.2%) belonged to the Class 2 obesity group (BMI = 35–40 Kg/m²), and 2264 patients (75.9%) belonged to the Class 3 obesity group (BMI > 40 Kg/m²). There were no significant differences between preoperative baseline characteristics in the different obesity classes.

Table 1

Patient Demographics Pre-Operatively
Demographics	Number (SD)/Percentage
Total Number of Patients	2982
Age at Surgery (Years) Obesity Class I Obesity Class II Obesity Class III	34.69 (11.25) 37.62 (11.50) 36.09 (10.40) 34.20 (11.38)
Gender Male Female	835 (28%) 2147 (72%)
Weight (Kg) Obesity Class I Obesity Class II Obesity Class III	122.66 (24.60) 94.57 (10.15) 103.30 (11.22) 128.99 (23.84)
BMI (Kg/m²) N in Obesity Class I N in Obesity Class II N in Obesity Class III	45.50 (7.73) 93 573 2264

The most prevalent pre-operative weight-related medical illness was diabetes (n = 309), followed by hypertension (n = 298) and obstructive sleep apnea (n = 127). The mean follow-up period was 8.60 (± 3.05) years.

Weight Outcomes

Mean weight at 13 years was 84.57 Kg (Table 2), corresponding to a mean BMI of 31.83 Kg/m² (Table 3), an EWL% of 69.6% (Table 4) and TWL% of 31.43% (Table 5). The highest excess weight loss was achieved at 4 years post-op (EWL = 74.35%), while the highest total weight loss percentage was achieved at 18 months post-op (TWL = 32.96%) (Fig. 2). This corresponded to a %EWL of 101.72% in patients that were classified in the Class I obesity group pre-operatively, 78.34% in Class 2, and 71.73% in Class 3, respectively; and a %TWL of 34.12% in Class 1, 30.87% in Class 2, and 33.54% in Class 3, respectively.

Table 2

Weight Change with time post-operatively; divided between the three obesity classes
Weight Post-LSG (Kg)	All Patients	Obesity Class I	Obesity Class II	Obesity Class III
2 weeks (n = 1490) 3 months (n = 1084) 6 months (n = 708) 1 year (n = 929) 18 months (n = 174) 2 years (n = 183) 3 years (n = 143) 4 years (n = 91) 5 years (n = 53) 6 years (n = 33) 7 years (n = 44) 8 years (n = 58) 9 years (n = 122) 10 years (n = 10) 11 years (n = 29) 12 years (n = 19) 13 years (n = 28)	113.92 (24.00) 104 (22.13) 95.51 (21.08) 91.08 (39.34) 84.37 (18.42) 82.13 (18.52) 81.60 (18.02) 81.57 (17.00) 88.81 (16.00) 82.81 (18.42) 89.49 (18.54) 88.48 (19.66) 89.90 (10.72) 92.20 (24.86) 92.17 (21.66) 94.47 (20.26) 84.57 (16.49)	86.64 (10.00) 79.63 (6.96) 73.08 (6.76) 72.00 (10.08) 56.00 65.75 (14.38) 62.00 (2.64) 69.00 (6.32) 87.00 (4.24) 81.00 83.00 - 79.33 (16.77) 75.00 81.00 72.00 95.00	94.75 (11.92) 86.79 (10.79) 78.43 (10.04) 76.69 (11.24) 73.90 (13.58) 72.40 (13.48) 81.29 (12.41) 76.83 (12.47) 78.67 (13.62) 80.38 (20.97) 83.86 (14.29) 77.44 (10.64) 83.43 (14.78) 72.67 (8.74) 88.71 (20.83) 84.25 (6.55) 70.40 (10.14)	119.69 (23.40) 108.73 (21.78) 99.74 (20.84) 93.47 (19.54) 85.98 (18.53) 85.38 (18.79) 82.32 (19.07) 85.48 (18.70) 93.46 (15.67) 83.15 (14.77) 91.44 (19.29) 90.51 (20.32) 91.78 (21.75) 104.83 (24.54) 93.86 (22.65) 99.00 (21.57) 87.32 (16.41)

Table 3

BMI Change with time post-operatively; divided between the three obesity classes
BMI Post-LSG (Kg/m²)	All Patients	Obesity Class I	Obesity Class II	Obesity Class III
2 weeks (n = 1490) 3 months (n = 1084) 6 months (n = 708) 1 year (n = 929) 18 months (n = 174) 2 years (n = 183) 3 years (n = 143) 4 years (n = 91) 5 years (n = 53) 6 years (n = 33) 7 years (n = 44) 8 years (n = 58) 9 years (n = 122) 10 years (n = 10) 11 years (n = 29) 12 years (n = 19) 13 years (n = 28)	42.58 (7.96) 38.94 (7.55) 35.74 (7.21) 33.97 (13.33) 31.78 (6.63) 30.39 (6.05) 30.43 (6.73) 29.84 (5.44) 32.09 (7.51) 31.47 (6.12) 33.09 (6.64) 32.91 (6.78) 32.73 (6.96) 33.12 (6.33) 33.74 (6.66) 35.95 (7.85) 31.83 (6.27)	30.87 (1.67) 28.52 (1.93) 26.78 (2.71) 25.52 (3.00) 22.15 26.02 (6.21) 24.84 (1.32) 25.32 (3.19) 28.96 (4.69) 29.04 31.24 - 30.79 (5.46) 28.93 24.45 25.82 29.65	35.05 (2.24) 32.01 (2.49) 29.07 (2.81) 28.15 (3.65) 25.96 (4.80) 26.42 (4.02) 29.66 (5.01) 27.80 (3.69) 28.58 (3.96) 29.00 (3.31) 31.82 (4.38) 28.74 (2.93) 30.61 (4.13) 28.20 (3.96) 30.54 (5.29) 30.47 (3.92) 26.35 (3.89)	44.83 (7.46) 40.73 (7.27) 37.39 (6.92) 35.07 (6.67) 32.66 (6.44) 31.70 (5.99) 30.74 (7.07) 31.53 (5.78) 33.77 (8.28) 33.49 (7.24) 33.65 (7.04) 33.67 (7.02) 33.30 (7.45) 36.28 (5.98) 35.25 (6.58) 38.24 (7.68) 33.18 (6.19)

Table 4

Percent EWL with time post-operatively; divided between the three obesity classes
EWL %	All Patients	Obesity Class I	Obesity Class II	Obesity Class III
2 weeks (n = 1490) 3 months (n = 1084) 6 months (n = 708) 1 year (n = 929) 18 months (n = 174) 2 years (n = 183) 3 years (n = 143) 4 years (n = 91) 5 years (n = 53) 6 years (n = 33) 7 years (n = 44) 8 years (n = 58) 9 years (n = 122) 10 years (n = 10) 11 years (n = 29) 12 years (n = 19) 13 years (n = 28)	18.01(11.08) 37.71 (15.53) 54.58 (19.42) 61.94 (45.87) 71.89 (30.08) 74.99 (28.00) 72.94 (33.67) 74.35 (29.22) 65.12 (30.28) 61.26 (30.63) 59.55 (30.66) 63.26 (26.58) 59.96 (31.55) 60.47 (21.04) 56.60 (33.38) 50.76 (24.27) 69.60 (27.66)	31.85 (15.67) 60.08 (19.05) 82.59 (30.15) 98.16 (38.52) 133.04 91.50 (65.44) 101.82 (14.09) 101.72 (45.64) 59.35 (47.63) 44.38 29.69 - 39.54 (53.39) 59.53 108.54 88.77 48.45	22.86 (13.25) 45.94 (17.46) 69.44 (21.28) 76.60 (27.66) 94.32 (38.40) 89.64 (30.80) 63.59 (38.77) 78.34 (27.86) 70.92 (35.53) 67.43 (28.26) 47.33 (33.87) 72.81 (21.84) 54.79 (35.81) 72.38 (32.93) 55.07 (45.26) 59.82 (26.81) 91.85 (28.82)	16.39 (9.51) 35.36 (13.78) 50.73 (15.98) 59.29 (20.33) 69.69 (21.85) 71.13 (22.17) 74.72 (32.42) 71.73 (22.83) 63.94 (27.63) 61.59 (32.72) 61.44 (29.23) 61.51 (27.19) 61.84 (29.79) 54.67 (15.40) 54.63 (28.39) 45.46 (21.97) 65.51 (25.86)

Table 5

Percent TWL with time post-operatively; divided between the three obesity classes
TWL %	All Patients	Obesity Class I	Obesity Class II	Obesity Class III
2 weeks (n = 1490) 3 months (n = 1084) 6 months (n = 708) 1 year (n = 929) 18 months (n = 174) 2 years (n = 183) 3 years (n = 143) 4 years (n = 91) 5 years (n = 53) 6 years (n = 33) 7 years (n = 44) 8 years (n = 58) 9 years (n = 122) 10 years (n = 10) 11 years (n = 29) 12 years (n = 19) 13 years (n = 28)	7.63 (4.26) 16.25 (5.81) 23.82 (6.96) 27.49 (9.28) 32.96 (11.61) 31.79 (10.83) 32.02 (15.01) 30.14 (10.65) 27.38 (12.80) 25.46 (13.04) 25.62 (14.07) 27.94 (12.15) 26.31 (14.79) 24.42 (8.06) 23.55 (13.26) 20.85 (9.16) 31.43 (13.16)	8.07 (4.04) 14.80 (4.07) 20.68 (6.40) 23.89 (7.26) 34.12 25.13 (17.16) 27.60 (3.79) 24.49 (6.85) 16.11 (12.57) 10.00 7.78 - 10.18 (14.20) 16.67 22.11 20.00 12.84	7.70 (4.39) 15.50 (5.81) 23.62 (6.88) 25.97 (9.02) 30.87 (11.65) 30.72 (10.45) 21.43 (13.21) 26.32 (9.62) 24.02 (11.82) 22.73 (9.80) 15.82 (10.94) 25.14 (6.73) 19.17 (12.58) 23.97 (12.14) 17.43 (13.43) 19.94 (7.65) 31.35 (8.24)	7.58 (4.25) 16.46 (5.85) 23.98 (6.99) 27.94 (9.33) 33.54 (11.08) 32.59 (10.43) 34.22 (14.69) 33.05 (11.00) 29.37 (13.11) 28.30 (15.14) 28.36 (13.78) 28.46 (12.88) 28.52 (14.56) 25.93 (6.55) 25.66 (13.20) 21.16 (10.11) 32.29 (13.88)

Mean nadir weight achieved, measured 10 months onwards post-LSG, was 86.86 Kg (± 19.53), corresponding to a nadir BMI of 32.35 Kg/m² (± 6.91). This weight loss equated to a mean nadir excess weight loss (EWL) of 67.03% (± 27.65). Overall, 31 patients (17.8% of patients with data at 18 months; 1.04% of total patient population) attained insufficient weight loss, defined as an excess weight loss percentage of < 50% 18 months post-LSG [21], while a total of 40 patients (1.3% of total patient population) experienced weight regain, defined as progressive weight regain that occurred after achieving an initial successful weight loss (defined as an EWL > 50%) [21] (Table 6).

Table 6

Morbidity and Co-morbidity Resolution
Comorbidities	Number (SD)/Percentage (%)	p-value
OSA Pre-op Obesity Class I Obesity Class II Obesity Class III Resolved Obesity Class I Obesity Class II Obesity Class III	127 (4.3% of total) 2 (2.2%) 26 (4.5%) 91 (4.0%) 93 (73.2%) 2 (100%) 21 (80.8%) 63 (69.2%)	0.000
HTN Pre-op Obesity Class I Obesity Class II Obesity Class III Resolved Obesity Class I Obesity Class II Obesity Class III	298 (10.0% of total) 9 (9.7%) 58 (10.1%) 220 (9.7%) 80 (26.8%) 3 (33.3%) 14 (24.1%) 59 (26.8%)	0.000
DM Pre-op Type 1 Obesity Class I Obesity Class II Obesity Class III Resolved Type 1 Obesity Class I Obesity Class II Obesity Class III	309 (10.4% of total) 31 (1.0%) 15 (16.1%) 66 (11.5%) 221 (9.8%) 119 (38.5%) 4 (12.9%) 7 (46.7%) 28 (42.4%) 83 (37.6%)	0.000
Bleed Obesity Class I Obesity Class II Obesity Class III	13 (0.4%) 1 (1.1%) 3 (0.5%) 9 (0.4%)
Leak Obesity Class I Obesity Class II Obesity Class III	16 (0.5%) 0 (0%) 2 (0.3%) 14 (0.6%)
GERD Grade 1 Obesity Class I Obesity Class II Obesity Class III Grade 2 Obesity Class III Grade 3 Obesity Class III	237 (7.9%) 235 (7.7%) 8 (8.6%) 60 (10.5%) 158 (6.9%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 1 (0.1%)
Revisional Procedure Undertaken Obesity Class I Obesity Class II Obesity Class III Resleeve Obesity Class II Obesity Class III Bypass Obesity Class I Obesity Class II Obesity Class III OAGB Obesity Class III Time until Revisional Procedure (yrs) Obesity Class I Obesity Class II Obesity Class III	34 (1.1%) 2 (2.2%) 7 (1.2%) 25 (1.1%) 9 (0.3%) 2 (0.3%) 7 (0.3%) 20 (0.7%) 2 (2.2%) 5 (0.9%) 13 (0.6%) 5 (0.2%) 5 (0.2%) 5.27 (2.64) 7.45 (4.04) 7.18 (4.01) 7.47 (5.42)
Insufficient Weight Loss Obesity Class I Obesity Class II Obesity Class III Weight Regain Obesity Class I Obesity Class II Obesity Class III 18 months 2 years 3 years 4 years 5 years 6 years 7 years 8 years 9 years 10 years 11 years 12 years 13 years 16 years	31 (1.04%) - 2 (6.5%) 29 (93.5%) 40 (1.3%) 2 (2.1%) 8 (1.4%) 29 (1.3%) 3 (0.1%) 2 (0.1%) 2 (0.1%) 1 (0.0%) 0 (0.0%) 1 (0.0%) 2 (0.1%) 5 (0.2%) 6 (0.2%) 2 (0.1%) 9 (0.3%) 5 (0.2%) 3 (0.1%) 0 (0.0%)

Baseline characteristics of patients that did not experience weight regain (WR) vs patients that experienced weight regain (WR) did not show statistical differences (p > 0.005): age at LSG 36.78 years old (± 11.34) vs 26.00 years old (± 1.41), respectively; pre-operative weight 125.67 Kg (± 23.67) vs 143.00 Kg (± 19.80), respectively; pre-operative BMI 45.33 Kg/m² (± 7.47) vs 42.70 Kg/m² (± 0.10), respectively.

There was a significant difference between starting obesity class and TWL at 2w (p = 0.001; obesity class 1 with the highest TWL) and 1y (p = 0.000; obesity class 3 with the highest, followed by class 2, and class 1). There was also a significant difference between starting obesity class and weight regain at 13 years (p = 0.011; obesity class 3 with the highest weight regain, followed by obesity class 1, then class 2).

Interestingly, we noted a significant difference between starting obesity class and weight (p = 0.000) at 2w, 3m, 6m, 1y and 18m.

Comorbidity Outcomes and Complications

Significant reductions of comorbidities associated with LSG from baseline were observed in patients suffering from hypertension, obstructive sleep apnea and diabetes mellitus (DM) (p < 0.001 for all parameters) (Table 6). Of the patients that were diagnosed with type 1 DM pre-operatively, 4 patients experienced remission post-LSG (12.9%), defined as a decrease in insulin requirements.

Post-LSG complications encountered included bleed, in 13 patients (0.4%), and leak in 16 patients (0.5%). Gastroesophageal reflux disease (GERD) was encountered in 237 (7.9%) of patients post-LSG, with the majority classified as Grade 1 GERD (235; 7.7%).

Revisional bariatric procedures were undertaken by 34 patients post-LSG (1.1%) after an average of 5.3 years, with the majority undergoing a revisional Roux-en-Y gastric bypass (n = 20; 0.7%). The reasons behind the need for revisional surgery were weight regain (n = 22; 64.7%), development of GERD (n = 8; 23.5%), insufficient weight loss (n = 2; 5.9%) and the development of hypoglycemic episodes (n = 2; 5.9%). Kaplan-Meier analysis for freedom from need for revisional procedures can be seen in Fig. 3.

When the use of sleeve gastrectomy’s began to rise in 2014, overtaking all other bariatric surgeries being performed at the time, no long-term data had existed on it’s weight loss outcomes, making quantification of success difficult to predict when recommending this procedure. Our study aimed to report the long-term weight loss and comorbidity status outcomes of patients that had undergone laparoscopic sleeve gastrectomy as a primary bariatric procedure. The main findings of our study were to provide an insight on the successful long-term weight loss achieved after LSG, as well as the control of comorbidities associated with untreated obesity.

Primary LSG led to a sustained %EWL > 50% throughout the follow-up period of 13 years, comparable to other previously published studies investigating long-term results post-LSG [22–24]. However, until recently, finding studies reporting on > 7 year outcomes were rare, with the majority being published between the years of 2018–2021 [24–32]. A meta-analysis conducted by Clapp et al.[11] in 2018 was able to demonstrate successful weight loss achieved by patients at 7 + years post LSG, with 72.2% achieving a %EWL of > 50%, while a systematic review conducted by Juodeikis et al. [33] was able to report a mean %EWL of 54.8% at 8 years post operatively. This has been emulated by our current study, with EWL standing in the range of 50.76–69.60 at 7 + years post-LSG.

Weight regain was defined as progressive weight regain that occurred after achieving an initial successful weight loss (defined as EWL > 50%), while insufficient weight loss was defined as an excess weight loss percentage of < 50% at 18 months post-LSG [21], however, it is important to note that there is yet to be a standardized definition for these factors [34–37], making reporting outcome comparison complicated. Nonetheless, by the definition we use at our institute, the rates of weight regain and insufficient weight loss was 1.3% and 1.04%, respectively. These numbers were significantly lower than those encountered by previous studies such as that of Clapp et al., with a pooled weighted mean proportion of weight regain demonstrated to be 27.8% (range = 14–37%) [11]. However, it should be taken into consideration that our follow up percentage declined with time, with results obtained from 50% of patients at 2 weeks post-op, 31% of patients at 1 year post-op, and from 4% of patients at 9 years post-LSG, which could have affected follow-up results collected. A study conducted by Capoccia et al. [26] defined weight regain of ≥ 15 - <30% of maximum weight lost as mild, while a weight regain of > 30% was defined as severe. According to this definition, 61 of our patients (2%) experienced mild weight regain and 79 patients (2.6%) experienced severe weight regain post operatively. When using the definition created by Sakran et al. [38], patients that regained < 25% of maximum weight lost were classified as having experienced mild weight regain, while those that regained ≥ 25% were classified as having experienced significant weight regain. According to this definition, 650 of our patients (22%) experienced mild weight regain, while 98 patients (3.3%) experienced significant weight regain. Further, our current study’s cohort had a mean percentage weight regain of maximum weight loss of 32.89%, slightly lower than that reported by Sakran et al. (33.4%), while being slightly higher than that reported by Capoccia et al. (31.5%) [26].

Although the success of laparoscopic sleeve gastrectomy is no longer disputed, complications and failures following this procedures still exist, with weight regain and the recurrence of obesity being one of the major worries for patients and surgeons alike. This is where revisional/secondary bariatric procedures come into play. Revisional bariatric procedures following laparoscopic sleeve gastrectomy have conversely been on the rise, making it a main research topic in recent years [39, 40]. However, the results of our long-term analysis was able to demonstrate a need for a revisional procedure in only 1.1% of our cohort, with the majority needing to be converted to a Roux-en-Y gastric bypass. This is quite small a number when compared to previous studies looking at long-term outcomes. For example, the study conducted by Felsenreich et al. [27] followed their patients for greater than 15 years, demonstrating a %EWL of 61% at the end of the study period, however, this was encountered with a high revision rate of 49.1%. Arman et al reported a reoperation rate of 31.7% [41] and Kowalewski et al. demonstrated a revision rate of 16% after an 8 year follow-up period [42].

When it came to looking at resolution of comorbidities associated with obesity, we were able to demonstrate positive results, with a 73.2% resolution rate of patients with obstructive sleep apnea, a 26.8% resolution rate of hypertension, and a 38.5% resolution rate of type 2 diabetes mellitus. These numbers are lower than those seen by the study conducted by Kraljevic et al., with 60.5% resolution rates of hypertension and 61% resolution rates of DM [43]; as well as those encountered by Sakran et al. [38], with 51.7% resolution of hypertension, and a 72.2% resolution rate of DM encountered. On the other hand, complications encountered following the sleeve procedure were small in number with bleed encountered in 0.4% of patients post-op and a leak diagnosed in 0.5% of the patient population. This is comparable to other studies with post-operative leak rate for LSG varying between 1 and 3% for a primary procedure [44, 45], while incidence of bleeding following LSG’s has been reported to range between 1.16–4.94% [33].

Gastroesophageal reflux disease has recently become a major concern following the performance of sleeve gastrectomy due to the association that has linked the two together. There have been multiple mechanisms proposed to explain this phenomena, and those include the large compliant stomach being transformed into a long and narrow tube. This implies a lack of gastric compliance, with an increased intraluminal pressure that correlates inversely with the diameter of the gastric tube and is increased when the pylorus is closed. Other factors are related to dismantling of the anatomical anti-reflux mechanisms, including disruption to the Hiss angle and resection of the sling fibers in the distal part of the lower sphincter, which results in low esophageal-sphincter pressure. The final shape of the sleeve also plays a role as it may favor GERD and regurgitation when it is funnel-shaped. The role of the gastric antrum has not been fully clarified but it is thought that extensive resection of the antrum may impair gastric emptying and favor GERD [46]. However, previous studies have been inconsistent with the effect that sleeves have on GERD. A national analysis conducted by DuPree et al. was able to show that 84.1% of patients that had pre-existing GERD continued to have GERD symptoms post LSG, while 8.6% developed GERD postoperatively [47]. The mechanisms in which GERD may improve after undergoing LSG include the decrease in intra-abdominal pressure due to weight loss, reduced acid production related to resection of the acid-producing gastric fundus, accelerated gastric emptying, and reduced gastric volume [14, 48]. Our study was able to demonstrate low de novo GERD rates, with only 7.9% of patients developing GERD, 99% of which classified as Grade 1. This is significantly lower than the number demonstrated by Kowalewski et al. (44% de novo GERD), Kraljevic et al. (32.4%) and Hauters et al. (43%) [30, 43], but closer to the percentage seen in Juodeikis et al.’s study (10%) [33], as well as Garg et al. [49] and Melissas et al. [50].

Even though this study looked at a large cohort of patients that underwent LSG over a long-term follow-up period of 13 years, it is not without it’s limitations. Firstly, the data was collected via phone calls, entailing a potential for information, recall, and response bias. We attempted to increase the validity of our data by collecting the majority of the information we could by utilizing hospital charts, and when needed, data were verified by a telephone interview. Secondly, due to the long follow-up period of the study, we have lost a significant number of patients to follow-up, making it difficult to quantify the full potential of our results. Finally, the study lacked objective measurements such as a medication list, blood test results, and imaging test results, and we could only base our results on presented symptoms and declared pharmacotherapy.

According to our results, LSG can be considered an effective bariatric procedure for weight loss, with a sustained %EWL up until 13 years post-operatively. Further, insufficient weight loss and weight regain were minimal within our cohort. Resolution of comorbidities was also seen to be satisfactory, and low complication rates were encountered within our cohort. Starting obesity class only significantly affected weight loss in the first 18 months post-operatively. It is, however, important to note, that increased patient engagement in follow-up routine is of crucial importance for the collection of long-term data following bariatric procedures.

The authors declare no conflict of interest.

Ethical Approval and consent to Participate: Ethical approval to conduct the study was obtained from the Ministry of Health and Kuwait Institute for Medical Specialization Ethical Approval Board. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent for study participation was obtained from all subjects (if subjects are under 16, from a parent and/or legal guardian).

Consent for Publication: Not Applicable

Competing Interests: The authors declare that they have no conflict of interest.

Funding: The authors declare no source of funding for the completion of this study.

Authors Contributions:

Conceived Project: S.AS.

Designed research: S.AS., E.AH.

Collected data: I.Q., M.AM., A.AA., A.AQ., A.AK., A.S., M.B.

Performed research: S.AS., E.AH.

Analyzed data: E.AH.

Wrote paper: E.AH.

Edited paper: S.AS., E.AH.

Acknowledgments: We would like to thank Kuwait University Research Sector for their support in producing this data.

Availability of Data and Materials: The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

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No competing interests reported.

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Beyond the Decade: Unveiling Long-Term Weight and Co-Morbidity Outcomes More Than 10 Years Post Laparoscopic Sleeve Gastrectomy

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Abstract

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Introduction

Methods

Patient Follow-Up

Pre-Operative Evaluation

LSG Procedure Technique

Definition of Co-morbidities – Diabetes

Definition of Co-morbidities – GERD

Definition of Co-morbidities – Hypertension (HTN)

Definition of Co-morbidities – Obstructive Sleep Apnea (OSA)

Postoperative Evaluation

Statistical Analysis

Results

Baseline Characteristics

Weight Outcomes

Comorbidity Outcomes and Complications

Discussion

Conclusion

Declarations

References

Additional Declarations

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