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ORIGINAL ARTICLE Table of Contents  
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Retrospective evaluation of mid- and long-term outcomes of bariatric surgery on obesity control in Indian population


 Department of Bariatric and Metabolic Surgery, KD Hospital, Ahmedabad, Gujarat, India

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Date of Submission26-Oct-2021
Date of Acceptance24-Apr-2022
Date of Web Publication02-Jun-2022
 

  Abstract 


Context: Bariatric surgery is an effective method in inducing significant weight loss in patients suffering from obesity. Despite the strong evidence on its clinical effects, the data on its mid- and long-term follow-ups and durability are limited. This study is to evaluate the impact of bariatric surgical procedures on weight loss and resolution of comorbidities after surgery. Subjects and Methods: This was a retrospective, single-center cohort study including 1468 participants in whom laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, one-anastomosis gastric bypass, and balloon were performed between 2010 and 2019. Standardized weight loss measures were compared using an analysis of covariance. Results: The mean (standard deviation) age of patients involved in this study is 43.41 ± 12.09 years with a preoperative weight and body mass index (BMI) of 117.23 ± 23.027 and 44.93 ± 8.02, respectively. The mean follow-up period is 2.9 years (0.83–9 years). Patients reported a mean percentage total weight loss (%TWL) of 8.1 ± 15.66%, percentage excess weight loss (%EWL) of 18.92 ± 40.56, and excess BMI loss of 18.38 ± 42.7 at the follow-up point of 9 years. The remission of diabetes was significantly improved by 17%. 0.89% of patients adhered to follow-up visits till the end of the study. Conclusions: Bariatric surgery demonstrated a beneficial association resulting in substantial weight loss and remission of diabetes. Further large, multi-site cohort studies on Indian population are needed to substantiate the evidence.

Keywords: Excess weight loss, laparoscopic sleeve gastrectomy, one-anastomosis gastric bypass, Roux-en-Y gastric bypass, total weight loss


How to cite this URL:
Khaitan M, Gadani R, Pokharel KN. Retrospective evaluation of mid- and long-term outcomes of bariatric surgery on obesity control in Indian population. J Bariatr Surg [Epub ahead of print] [cited 2022 Sep 24]. Available from: http://www.jbsonline.org/preprintarticle.asp?id=346520





  Introduction Top


Bariatric surgery is an effective intervention for long-term weight loss as well as to ameliorate obesity-related comorbidities.[1] Considerable evidence has suggested that bariatric surgery is associated with improvement or remission of type 2 diabetes in patients with obesity, reducing the mortality rate linked to diabetes.[2],[3],[4],[5] In addition, bariatric surgery has shown to provide additional health benefits, including improvements in cardiometabolic comorbidities such as dyslipidemia, hypertension, and obstructive sleep apnea.[6] Owing to these favorable outcomes, the use of bariatric surgery is evolving rapidly resulting in a noticeable increase in the number of procedures undertaken globally.

Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) are the most accessible bariatric surgeries for weight loss surgery which are found to be superior than other procedures such as adjustable gastric banding.[7],[8],[9],[10],[11] Intragastric balloon placement is a simple endoscopic method offering a minimally invasive and expansive role for managing obesity and associated conditions.[12] Another promising bariatric procedure, i.e., one-anastomosis gastric bypass (OAGB), is found to be at least as effective as RYGB in terms of weight loss and comorbidity resolution and associated with fewer major complications.[13],[14] It is noninferior to other established bariatric procedures and is particularly suitable for metabolic/diabetes treatment.[15]

Despite the availability of these techniques, the evidence on the durability of weight loss is minimal as only a few Indian studies have reported mid- and long-term follow-up outcomes in patient cohorts.[16],[17],[18],[19],[20] Most published studies of bariatric surgery are retrospective, short-term studies with insufficient follow-up.[21] In a systematic review of 7371 bariatric studies, only 29 studies (0.4%) associated with 7971 patients had 2 years of follow-up, out of which only 4 studies had 5 or more years of follow-up.[22] Incomplete follow-up has been a limitation to the interpretation of registry-based reports on the safety profile of bariatric surgical procedures.[23] Despite the proven efficacy of bariatric surgery in short-term follow-up, data regarding its mid-and long-term outcome on weight loss and comorbidities are still limited and need to be further evaluated, particularly from Indian population. In this study, four surgical procedures, i.e., RYGB, LSG, OAGB, and balloon, have been used to induce weight loss and lower comorbid risk factors in individuals suffering from obesity. To address the mid- and long-term durability of these procedures, we analyzed 9-year weight change in patients with the aim to provide evidence for clinical practice.


  Subjects and Methods Top


This is a single-center, retrospective cohort study aimed at evaluating the impact of bariatric surgery on weight control in patients suffering from obesity in Indian population. One thousand four hundred and sixty-eight participants who underwent bariatric surgery during the years January 2010–December 2019 were included in this study. Follow-up data were accessed until 2019, and the best available data for each patient were collected telephonically as well as from hospital electronic records. Preoperatively, participants were evaluated for medical or surgical history, and a clinical examination was performed. Baseline characteristics including age, height, weight, and body mass index (BMI) were recorded. Weight and BMI were recorded before and after bariatric surgery. Risk factors and comorbidities, including arterial hypertension, diabetes mellitus, and hypothyroidism rates, were collected. Then, one of the four following surgical procedures was used: RYGB, LSG, OAGB, and balloon. After surgery, percentage total weight loss (%TWL), percentage excess weight loss (%EWL), percentage excess BMI loss at ideal BMI 25, and comorbidity status at different follow-up times were analyzed. Remission of hypertension was defined as normal BP levels at 12 months (systolic BP <140 mmHg and diastolic BP <90 mmHg) without antihypertensive therapy.[24] Remission of hypothyroidism, as per the 2016 American Thyroid Association hyperthyroidism guidelines, was defined as laboratory euthyroidism 1 year after discontinuation of medication.[25]

The study protocol was approved by the institutional ethics committee, and all patients provided informed consent before entering the study. All procedures performed in this study involving human participants were in accordance with the ethical standards of the International Council for Harmonisation guidelines for Good Clinical Practice.

Statistical analysis

All the continuous variables were assessed for normality using a Shapiro–Wilk's test. All the categorical variables were expressed either as percentage or proportion. The comparison of all the normally distributed continuous variables was done by independent sample t-test or Welch's test depending on variance. For normally distributed variables, a comparison of two related groups was checked with pair t-test, and for more than two groups, one-way ANOVA was used. All the nonnormally distributed continuous variables' comparisons were done by Mann–Whitney “U” test, based on the number of groups. Comparisons of categorical variables were taken care by either Chi-square test or Fisher's exact test based on the number of observations. For paired dichotomous nominal data, to test the statistical difference, McNemar's test or binomial test was performed based on the number of observations available. Statistical analyses were performed using IBM SPSS statistics software version 20 (Chicago, IL, USA). All “P” < 0.05 were considered statistically significant.


  Results Top


A total of 1468 participants underwent bariatric surgery during the study period. Of them, 891 (60.7%) were women and 577 (39.3%) were men. The mean age of the participants was 43.41 ± 12.09 (standard deviation) years (range: 6–78 years). The mean height, preoperative weight, and preoperative BMI were 161.57 ± 9.878, 117.23 ± 23.027, and 44.93 ± 8.02, respectively. Among the enrolled participants, RYGB surgery was adopted by 940 (65%) patients, sleeve gastrectomy by 444 (30.7%) patients, OAGB by 49 (3.4%) patients, and balloon by 7 (0.5%) patients. The presurgical characteristics of patients are found in [Table 1]. The details of number of surgeries performed on a yearly basis are shown in [Figure 1].
Table 1: Overall baseline characteristics and preoperative variables (n=1468)

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Figure 1: Distribution of number of surgeries performed per year

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In our cohort, there is a decline in terms of adherence to long-term follow-up after bariatric surgery, with 0.89% of patients completing the 9 years of follow-up. The mean follow-up from the time of surgery was 2.9 (±2.30) years, and the median follow-up was 2.29 years [Figure 2].
Figure 2: Percentage of follow-up at different time intervals post bariatric surgery

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Weight at different follow-up times during 9-year follow-up period

From the statistics of patients who underwent RYGB, LSG, OAGB, and balloon, we calculated the %TWL, %EWL, and the percentage excess BMI loss at ideal BMI 25 at different follow-up times. Follow-up weight data were obtained from measurements recorded in the electronic health records during outpatient visits, as well as by contacting patients through SMS, available messenger, and telephone from 2010 through 2019. Preoperative weight data were available for 1439 patients with a mean weight of 117.23 ± 23.02, and 1 year after surgery, weight was reduced to a mean weight of 88.18 ± 24.14, which is statistically significant (P = 0.00). However, for only a small percentage of patients (n = 387, 26.9%), follow-up information was recorded at 1-year time point. At the end of 9 years, complete follow-up is available for 12 patients (0.8%) with a mean weight of 100.13 ± 18.855, which is statistically insignificant (P = 0.06).

After bariatric surgery, %TWL started to decrease from 21.19 ± 15.43% of the initial weight on month 1 after surgery to 8.1 ± 15.66% at the follow-up point of 9 years; however, the difference is statistically insignificant (P = 0.91) during long-term follow-up. The %TWL data of the patients with follow-up information at different follow-up times and outcomes are listed in [Table 2].
Table 2: Change in percentage total weight loss at different follow-up times

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In terms of %EWL at ideal weight of BMI 25, patients had maintained significantly greater weight loss from 49.4 ± 38.94 reaching to 18.92 ± 40.56 (P = 0.79) at 9 years [Table 3]. The mean BMI significantly decreased (4.52 ± 7.06, P = 0.93) at 9 years from 9.86 ± 7.905 1st postoperative month. The percentage excess BMI loss at ideal BMI 25 also reduced from 49.31 ± 39.254 to 18.38 ± 42.717 at 9-year follow-up.
Table 3: Change in percentage excess weight loss at ideal weight of body mass index 25 at different follow-up times

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Changes in relevant comorbidities

Among the patients (n = 1468), 408 (27.8%) had preoperative diabetes mellitus in whom remission rates were found to be increased from 64.5% (n = 263) at the 1st postoperative week to 81.6% (n = 333, 17% increase, P = 0.00) at a mean follow-up of 2.9 years. It is worth noting that hypertension rates decreased from 5.5% preoperative (n = 81) to 0.5% (n = 8, 5% reduction, P = 0.00) at mean 2.9 years. Remission of hypertension was reported to be occurred in 90.1% of patients (n = 73) at the mean follow-up and recurrence was reported in 23.5% of patients at a mean postoperative period of 2.9 years (n = 19). Hypothyroidism rates decreased from 4.8% (n = 71) to 1.6% (n = 24, 3% reduction, P = 0.00). Remission was observed in 66.2% of patients (n = 47) at the mean follow-up of 2.9 years, while recurrence was reported in 5.63% of patients at the 1st postoperative week (n = 4) [Table 4].
Table 4: Comorbidities status at different follow-up times

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  Discussion Top


In this single-center study, we address the mid- and long-term weight change and resolution of comorbidities associated with current bariatric procedures using a large cohort of patients with obesity. To our knowledge, this study is the one of its kind reporting four surgical procedures of bariatric surgery on the remission rate of comorbidities and weight loss in a diverse group of patients with obesity. Bariatric surgery has become a widely acknowledged treatment option to help control the obesity epidemic. Since bariatric surgical procedures are often irreversible interventions, outcomes must be assessed for long-term effects in a large sample size to minimize bias toward overly optimistic estimates of the intervention effectiveness. The evidence from our study concludes that patients were able to sustain significantly greater weight loss up to 9-year postoperative surgery. Our observations are consistent with the findings from the Swedish Obese Subjects study which reported a greater weight loss at 10 years associated with RYGB.[26] However, our follow-up rate for 10-year weight measures was substantially lower (0.89% vs. 66.0% of those eligible) than the Swedish Obese Subjects study.

In our study, the remission rates of diabetes (17%) were observed. The results seem to be quite lower than those previously reported, but the results are variable from one study to the other. For instance, a study which followed up for a period of 5 years reported the resolution of diabetes in 83% of their patients who underwent RYGB.[27] On the other hand, a recent randomized trial reported 42% remission after RYGB and 37% after SG 12 months after the surgery.[17] This discrepancy could be attributable toward the phenotypic differences among patients in our cohort.

Adherence to a frequent follow-up plan after bariatric surgery is suggested to be associated with improved weight loss.[28],[29],[30] The Centre of Excellence accreditation guidelines mandate persistent attempts to ensure routine follow-up after bariatric surgery.[31] In our retrospective study, the follow-up rates dropped from 24.73% at <1 year to 0.89% at 9 years attributing to incomplete retention or follow-up. For instance, a bariatric surgery outcome study reported treatment failure rates of 42% when 61% of the initial cohort was followed up 8 years after surgery.[32] However, evidence suggests that the ideal follow-up rate in bariatric surgery outcome studies is 80% or greater than any original cohort, and this is rarely achieved.[33],[34] On the contrary, many small single-institution studies demonstrated that adherence to routine follow-up is associated with improved weight loss. In a study, the number of postoperative visits was associated with higher percentage of excess body weight loss (%EBWL) and increased likelihood of %EBWL >50 at 12 and 24 months postoperatively.[29] Of note, low follow-up rates in our cohort suggest that additional mechanisms will need to be implemented to improve patient adherence and to generate a basis for the assessment of long-term impact of bariatric surgery.

This study has several important strengths, including a high degree of generalizability because we included outcomes from a diverse group of patients, and direct analysis of the four surgical procedures currently performed. On the flip side, the main limitation of our study, like in the majority of other retrospective studies, is that the high percentage of patients was lost to follow-up.


  Conclusions Top


The results of our study suggest that bariatric surgery demonstrated substantial weight loss and resolution of comorbidities as well as improved long-term outcomes. Our findings provide further evidence in reinforcing the significance of bariatric surgery in controlling obesity and its comorbidities. There is a need for additional studies to understand the long-term outcomes of bariatric surgery on obesity control from large, multi-site Indian cohorts that have a high degree of long-term follow-up.

Patient declaration of consent statement

Written consent was obtained from the study participants after explaining the details of the surgery, its pros and cons, and all intraoperative, early and late postoperative complications that could occur. Further, all participants were informed of the research and that the data would be used for research purposes, giving patients the right to decline participation.

Data availability statement

The data set used in the current study is available on request from Dr. Manish Khaitan/E-mail: [email protected]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Correspondence Address:
Manish Khaitan,
Department of Bariatric and Metabolic Surgery, KD Hospital, Sardar Patel Ring Road, Ahmedabad - 382 421, Gujarat
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jbs.jbs_5_21



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