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Laparoscopic Gastric Sleeve on 730 patients.

5 years follow-up

Ziad Makarem Kanso1, Luis González1, Reina Jiménez1, Natalia Echegaray1, Connye García2 1La Florida Clinic Institut . Caracas, Venezuelaziadmakarem@hotmail.com

2 Caracas University Hospital. de Venezuela Central University

Abstract: Introduction: Obesity has become the major epidemic of the 21st Century, increasing pathologies that are associated with it such as diabetes mellitus type 2 (DMT2), metabolic syndrome, hypertension, cardiovascular disease, among others, and adversely affecting quality of life and life expectancy. Laparoscopic Vertical Gastrectomy (LVG) has gained popularity as the primary surgical treatment of obesity.

Materials and Methods: A Prospective study of 730 patients undergoing Laparoscopic Gastric Sleeve (LGS) at La Florida

Clinic Institut between 2006 and 2012. Analysis: Sex (F-73%, M-27%), mean age 40.1 years; Initial body mass index (BMI) average 40.7.

Results: Average time for the LGS operation was 79 min, % of Excess Weight (%EWL) 72.1% at 5 years and lowering BMI

to 28.6%. Complications: Stapling line disruption were 1.09%; bleeding 1.2% ;pneumonia 0.5%; dehydration 1.3%; wound infection 5 cases (0.6%); stenosis 0%; obstruction 0%; conversions: 0%; mortality: 0%. A study of 42 patients with DMT234 (81%) had resolution; improvement in 8 (19%). Of 112 patients with hypertension, 70 (62.5%) had resolution, improvement in 28 (25%) and 14 (12, 5%) had no response.

Conclusion: We conclude that the LGS is a safe and effective primary treatment for obesity and co-morbidity such as

resolution of diabetes type 2 and hypertension.

Key words: Obesity, Laparoscopic Vertical Gastrectomy, Gastric Sleeve Surgery, Bariatric and Metabolic Surgery, Diabetes Mellitus Type 2.

___________________________________________________________________________________ Introduction:

Morbid Obesity (MO) has become an epidemic in the Western world and integrates what is called the civilization syndrome [1]. Millions of people in the United States and around the world are overweight or obese (severe overweight). When weight increases to an extreme level [2], it is called morbid obesity (MO). Obesity has reached epidemic proportions world-wide; where at least 2.6 million people die every year from obesity. According to World Health Organization, there are currently about 1.6 billion obese persons worldwide. The number has grown by 40% over the past decade. The U.S. is the first Western country to appear on the list,

ranking ninth; with 74.1% of the population having some degree of overweight, and 30% are clinically obese (BMI >30). Mexico ranks No. 19 with 68.1% of the population overweight and 26% obese. In Venezuela, ranked #24, 65.2% of the people over the age of 15 are overweight and 25% are obese. That puts us as the 24th fattest country in the world, according to the latest ranking of the WHO. Bariatric surgery is considered the most effective tool for the management of MO, since non-surgical therapeutic treatments such as diets, behavior modification, drugs and exercise alone or combined have not proven to be successful over the long term [3.4]. Furthermore, recent studies show that surgical treatment of obesity is

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associated with a high remission rate of metabolic diseases such as diabetes mellitus type 2 (DMT2), as well as hypertension, dyslipidemia, and obstructive sleep apnea metabolic syndrome [5,6]. On the long run, mortality is significantly reduced, particularly deaths caused by diabetes, hypertension and cancer [7,8]. Surgeries performed for the treatment of MO include, among others: Roux-En-Y Gastric Bypass (RNYGB), vertical gastrectomy (VG) or sleeve gastric and adjustable gastric banding (AGB), Biliopancreatic Diversion with Duodenal Switch (BPD/DS) [2,9,10]. Recently, Gastric Surgical Plication was introduced as an alternative for the treatment of obesity [11]

LGS was first introduced in surgery for extremely obese patients in order to lose "some" weight and then perform, with lower risk, a second biliopancreatic diversion (BPD) or gastric surgery [12 -18]. For approximately the last 8 years, LGS has been used as a single surgical procedure in the treatment of MO. This procedure has a dual acting mechanism: restrictive and hormonal [19-26]. Likewise, recent reports show that the LGS produce DMT2 cure or improvement and metabolic syndrome remission ranging from 60% to 90% [26-29].

Acting Mechanism

LVG removes out much of the gastric antrum, body and gastric fundus producing strong restrictive effect, decreasing the gastric capacity approximately 40 to 100 cc. In addition, the pylorus behaves like a natural "band" regulating the passage of food.

As the gastric fundus is removed, the main source of Ghrelin production is eliminated, particularly in PD1 cells [30]. Ghrelin is a potent Orexigen hormone, also known as "hunger" hormone, that is also hyperglycemic since it increases food ingest; decreases insulin secretion, interferes with the recipient’s target organs, decreases the secretion of Adiponectin hormone, sensitizing to the action of insulin, and increases the secretion of Cortisol, ACTH and growth hormone, all of which are hyperglycemic agents.

ACTING MECHANISM

RESTRICTIVE GASTRIC VOLUME

WEIGHT LOSS AND DISMINUCION DE

GLICEMIA

METABOLIC EFFECT GHERLIN GLP-1 PYY ADPN APPETITE SUPRESSION GLUCOSE HOMEOSTASIS

Gastric sleeve

Chart 1. Action Mechanism

LGS also elevates Glucacon-like Peptide-1 (GLP-1), a potent incretin produced in L cells of posterior ileum and colon exerting a regulating effect in glucose metabolism. GLP-1 stimulates the secretion of insulin, suppresses the secretion of glucagon, slows gastric emptying, increases pancreatic beta cells mass, improves insulin sensitivity, decreases beta cell apoptosis and promotes the elimination of glucose. It has also been shown that LGS increases the production of the PYY peptide produced in posterior ileum with anorectic effect. When VG is performed, a strong restrictive effect occurs and a concomitant hormonal and regulatory effect of glucose metabolism significantly reducing the production of Ghrelin, elevating GLP-1, adiponectin and PYY, that translates into decreased weight and regulation of glucose homeostasis [2,3,31-37]. (CHART 1)

Patients and Methods

From June 2006 until January 2012, over a period of six years, 730 LGS’s were performed for the treatment of MO on patients with BMI between 32 and 65. Patients with very high risk and pregnant women were excluded. 533 LGS were performed on women (73%) and 197 on men (27%). Ages ranged between 18 and 65 years, with an average of 43 years. The BMI average was 40 (32-65).

Pre-Surgery Care

An informative, nutritional and psychological discussion was established beforehand. A diet rich in protein and low in carbohydrates (1000-1400 cal/day) was introduced two weeks prior to surgery, along with pulmonary, cardiac, gastrointestinal, endocrine and psychiatric assessment. One hour before surgery, Prophylactic antibiotic is administered; anti-embolism

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stockings and intermittent pneumatic compression are utilized.

Surgical Technique

Patient is placed in dorsal decubitus, with the head elevated 30 degrees (Reversed Trendelenburg Position) and slightly rotated to the left. Five ports (4 are 5 mm and 1 is 12mm) and a 5 mm 30° lens are placed in the upper abdomen. With the aid of a laparoscope, a 34 gauge Fr esophageal bougie is introduced through the mouth to cross the pylorus. Ligasure ® (Covidien Co. U.S.) or Harmonic Scalpel ® (J & J Co. U.S.)was used to clear the bigger curvature, 2 cm. of the pylorus as far as the angle of His. Subsequently, using a self-suturing laparoscopic lineal cutting machine with green refill triple row of 60mm staples and guided by the bougie, a vertical gastrectomy started from the antrum to a distance of about 2 cm. of the pylorus until the angle of His, clearing 1 cm away from the esophagus as the last staple. We only use green staples, reinforce the binding sites and the distal third with sutures or clips. In case of surface bleeding, this will be controlled by suture and haemostatic clips. Subsequently, the piece will be removed by an incision of approximately 12 mm. A closed suction drain tube, Blake-type (J & J Co. U.S.) is placed in the sub-phrenic area. Patients will be transferred afterwards, to recovery room, since majority of no need of an intermediate care unit.

Post-Surgery care

A liquid diet is administered 24 hours after surgery (30 c/c of clear liquids every 30 minutes) up to two weeks, afterwards, four weeks of blended-strained diet, liquefied diet, soft mashed food diet, and then complete diet and stressing the importance of chewing and staying hydrated. Respiratory exercises (triflow, percussion) for 10 days. Medicine gastric protection is used for 6 weeks to guard the Proton pump. Cardiovascular exercise by walking at least 30 minutes one week after the operation and gym (treadmill and climbing) a month after.

Results

Mean surgery time is 79 minutes. Average hospital stay is 2.1 days. It was possible to follow up on 549 patients (75.2%). POL was determined at years 1, 2, 3, 4 and 5 obtained 70.1%, 80.2%, 75.5%, 70.3% and 70.4% respectively and for lowering the same average BMI period was 30.4%, 27.1%, 28.1%, 29.3% and 29.2% respectively. See Table I, Fig. 2 and 3.

Graph 2. BMI changes

Years 1Year 2 Years 3 Years 4 Years 5 Years Months 12 24 36 48 60 BMI 30.4 27.1 28.1 29.3 29.2 POL 70.1 80.2 75.5 70.3 70.4

Table I: BMI and %EWL over 5 years

COMPLICATIONS Total: 36 cases (4.9%) / N:730

- Staple-line disruption. 8 cases (1.09%) - Bleeding. 9 cases (1.2%)

- Pneumonia. 4 cases (0.5%) - Dehydration: 10 cases (1.3%)

- Surgical site infection: 5 cases (0.6%) - Stenosis: 0 %

- TVP: 0 % - Conversion 0% - Mortality: 0%

Table II. Complications

0

20

40

60

0 6 1218243036424860

Months

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Fig.3. Change in %EWL

Co-morbidities

A study of 42 DMT2 patients treated with hypoglycemic or insulin, 34patients(81%) did not need any medication. Doses and medications for the other 8 (19%) were significantly reduced (Fig. 4).

We evaluated 112 patients with hypertension, 70 (62.5%) of whom normalized their blood pressure without any treatment, 28 patients (25%) significantly decreased their medication doses; the remaining 14 cases (12.5%) experienced no change in their blood pressure (Fig. 5).

Fig. 4: Effects on diabetes

Fig.5. Changes in HBP

Complications

36 (4.9%) of the 730 patients, had complications (Table II).

Complications were:

1. Disruption in staple line: - 8 cases (1.09%) occurred between 4-23 days, on average after 9 days. All patients that experienced leak at the staple line happened in the upper tract and were all clinically diagnosed: (tachycardia > 100 beats per minute, leukocytosis, gastrointestinal series with water-soluble contrast media or CT). All cases were treated with Blake drains (J & J Co. U.S.), antibiotic therapy, endoscopic self-expanding coated metal stent (Wallstent, Boston Scientific, Natick, MA, USA), and enteral and parenteral nutrition. All cases were resolved. The closure ranged from 1 to 6 weeks with an average of 4 days hospitalization, removal of prosthesis ranged between 4 to 8 weeks, with an average of 5 weeks. Only 1 patient (0.13%) required reoperation wash and drain placement.

2. Bleeding: 9 cases (1.2 %.). Eight were resolved with transfusion and one with re-intervention and transfusion; site of bleeding was not located on the latter patient.

3. Pneumonia:4 cases (0.5%) that was medically treated.

0

50

100

0 6 12 24 30 36 42 48 60

Meses

%EWL

81%

19%

Change in DM-T2

Resolución

62%

25%

13%

Effects on Arterial

Hypertension

Resolución

Disminución dosis

RESOLUTION

Resolution

Resolution

Resolution

Reduction of Dosis Months

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4. Dehydration: 10 cases (1.3%) were hospitalized between 24 to 48 hours for re-hydration, parenteral and enteral.

5. Surgical site infection: 5 cases (0.6%)

6. Mortality, stenosis, or DVT were not present.

Discussion

LGS is a procedure that was recently introduced for primary surgical management of MO and became popular for its efficiency, relative technical simplicity and low morbidity and mortality. It produces a significant restriction on food intake due to a reduced gastric capacity between 40 cc to 100 cc with a considerable reduction in Ghrelin levels, and potent Orexigen hormone that is produced in the fundus (which is resected).This results in a decrease in appetite and rapid satiety [20-23, 32, 35, 37-42] and consequently, a significant reduction in weight, BMI and the %EWL, which ranges from 55% up to 90% over three years as shown by (20,21,43-47).

In our study we demonstrate the effectiveness of LGS so far as the %EWL and decreased BMI that was tracked for a period of five years. One can see that in the first year there is a 70% %EWL, peaking at two years to 80.2%. Later, we observed a slight weight gain of about 10% up to four years reaching a %EWL of 70.2% and then stabilizing after four to five years at 70.3% (Table I). BMI behaves in a similar manner, falling to 30.4after one year; to 27.1after 2-years;28.1 after three years; 29.3 and 29.2 after four and five years respectively, figures that are comparable to RYGB [47-50].

Regarding metabolic response and comorbidities such as DMT2 and hypertension, we could provide an excellent metabolic response with DM-T2 submission up to 81% (34of 42 patients) with five years of follow-up considering fasting glucose less than 126 mg% and Glycosylated hemoglobin (HbG1Ac) less than 6.5%. Likewise, a significant improvement was observed in the rest, 19% (8 of 42 patients), of DMT2, decreasing doses of both insulin and oral hypoglycemic agents, as appropriate, for control. These results are consistent with recent studies published in the study of remission rates ranging from 70% to 90% in DMT2 [26-29,43-51]. There was also a significant finding concerning hypertension, with a direct relationship between the decrease in BMI and lower blood pressure. 112 hypertensive patients were studied after LGS. 70

patients (25%).That in turn, translated into reduced doses of drugs to control hypertension, so that 87.5% of patients who suffered with hypertension benefited from LGS. Sugerman [51] has shown the effectiveness and submission of hypertension with substantial weight loss. As for total complications, we had an incidence of 4.9%.Mortality at 0%, a low figure considering that the published incidence of complications ranges between 2.9% and 15.3% with a mortality of 0.3 % (39,40,43). Major complications such as disruption of the staple line and bleeding were 1.09% and 1.2% respectively, for a total of 8 patients.

The published leak rate ranges between 0.5% and 5% with an average of 2.7% [54.55]. All our leaks were in the upper third and treated with antibiotic, endoscopic self-expanding coated metal stent and drainage assisted by video-endoscopy. 5 drainages were percutaneous CT guided, 1 with laparoscopic aid, and 2 with Jackson-Pratt. We had a 100% resolution between 1-6 weeks and Stent removal between 4-8 weeks. Several studies support using prosthesis for resolving leakage LGS [56, 57,58]. Regarding bleeding (1.11%) and for a total of nine cases, 8 of were resolved with transfusion and 1 with transfusion and merited revision. Site of bleeding was not determined. Jossart [59] Similar has shown statistics.

Conclusions

 According to our experience, LGS is a very useful primary tool as an effective treatment of MO, it enjoys a relative technical simplicity and low morbidity and mortality rate. Furthermore, it also demonstrated the utility of the LGS in DMT2 and hypertensive patients regarding the cure or improvement ofthe same, so this technique should be considered in obese and/or metabolic syndrome. We also think that for such low risk, it is the proper technique in elderly patients, patients with inflammatory bowel diseases, patients with transplant, patients with musculoskeletal diseases and adolescent patients. We are also hope the same behavior of gastric sleeve in patients with BMI<35 and metabolic syndrome. Future studies will give us the answer.

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References

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