Sleeve Gastrectomy: Outcome, Morbidity and Mortality. A Multicentric Retrospective Trial
Sleeve Gastrectomy: Outcome, Morbidity and Mortality. A Multicentric Retrospective Trial
Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric
 procedure performed worldwide. LSG is a safe and effective technique in terms of excess
 weight loss and it is, moreover, a powerful metabolic operation that activates significant
 hormonal pathways that lead to changes in eating behavior, glycemic control and intestinal
 functions.Regarding a technical point of view, LSG might be considered a time saving
 procedure for the absence of intestinal anastomosis. The most frequent and sometimes
 dangerous complications are leaking, hemorrhage, splenic injury, stenosis and
 Gastro-Esophageal Reflux Disease (GERD). Despite its established efficacy and safety, dispute
 still exists on the optimal conduction of LSG operative technique: bougie size, distance of
 resection margin from the pylorus, the shape of section at the gastroesophageal junction,
 staple line reinforcement and intraoperative leak testing are among the most controversial
 issues .

 Thus, the primary aim of the present retrospective multicentric study is to evaluate intra
 and peri-operatory (< 30 days) and post-operative (> 30 days) morbidity and mortality rates
 of patients undergone LSG, and the correlation of the latter rates with different surgical
 measures. Secondary aim is to evaluate the strategy for the treatment of the complication,
 and if there is a correlation between morbidity/mortality and volume of the Bariatric Center
This study is a retrospective multicenter trial conduct from January 2015 to December 2020 in
 10 centers. All the procedures were performed by the (---- number of surgeons). Morbid
 obesity was preoperatively diagnosed according to the International Federation for Surgery of
 Obesity (IFSO) guidelines. Patients were collected in a electronic database and categorized
 according to the following parameters:

 -  Distance of resection margin from the pylorus (>5 cm / <5 cm)

 -  Bougie size (>34 French, <34 French)

 -  Distance of resection margin from the gastroesophageal junction (>…cm/<...cm)

 -  Staple line reinforcement (Yes/No - If yes, the reinforcement technique will be
 reported)

 -  Intraoperative leak testing (Yes/No - If yes, the test used will be reported)

 -  Number and size of trocar used and access closure technique (Yes/No - If yes, the
 technique will be reported) The study protocol was approved by the regional Ethics
 Committee. 2.2 Inclusion criteria Inclusion criteria were morbid obesity defined as BMI
 40 kg/m2 or BMI>35 with comorbidity and age between 25-60 years old. Obesity-related
 comorbidities included Type 2 Mellitus Diabetes (T2MD), hypertension, hyperlipidemia,
 bronchial asthma, osteoarthritis and degenerative joint disease.

 2.3 Exclusion Criteria Patients with endocrine disorders causing obesity (as hypothyroidism
 and Cushing disease), pregnancy or lactation, psychiatric illness, or recent diagnosis of
 malignancy, inflammatory bowel disease, Barrett ́s esophagus, and GERD with esophagitis
 scored as or greater than grade B, a large hiatal hernia (>3 cm) were excluded from the
 study.

 2.4 Study Outcomes The primary aims of the present retrospective multicentric study is to
 evaluate intra and peri and post operatory morbidity and mortality rates (< 30 and >30 days)
 of patients undergone Laparoscopic Sleeve Gastrectomy, and the correlation of the latter
 rates with different surgical measures. Secondary aims is to evaluate the strategy for the
 treatment of the complication, and if there is a correlation between morbidity/mortality and
 the volume of the Bariatric Center.

 2.6 Blinding Process Physicians and staff who will collect the data and those who will
 evaluate the endpoints will all be unaware of the patients allocation. Patients will be
 collected in an electronic database with consecutive numbers without the possibility of
 identifying the center of origin until the final evaluation of the study endpoints. As the
 blinding process for the operating surgeons is not feasible, they are not involved in data
 collection and evaluation of results.

 2.5 Pre-operative evaluation Preoperative evaluation included anthropometric measurements
 (height in cm, weight in kg, Body Mass Index (BMI) in kg/m2), comorbidity evaluation
 [Glycated Hemoglobin(A1c), C-peptide, stimulated C-peptide, Electrocardiography (ECG),
 echocardiography, lower limbs US color-doppler study, thyroid function profile]. All patients
 were evaluated for the presence/absence of Gastro Esophageal Reflux Disease before surgery
 through a preoperative upper endoscopy with an eventual esophageal biopsy. The presence of
 helicobacter pylori is also investigated with for a rapid urease test on an antral specimen.

 2.7 Surgical Technique The patient is placed in a split leg position with the surgeon located
 in between the patient's legs. Closed pneumoperitoneum was established using our standard
 technique of Verres needle insufflation in Palmer site and optical insertion of a 12-mm port
 at a supraumbilical site (10-15 cm from umbilicus) Two further 15-mm and 12-mm ports were
 placed respectively in the left and right ipocondrum as working ports. A subxiphoid track was
 created using a 5-mm port for placement of a liver retractor. In patients with higher body
 mass index who have severe visceral obesity, additional trocars can be added for retraction
 of the omentum or big fatty livers, to optimize the exposure to reach the left crus. Once the
 left crus is reached, an optimal exposure of the hiatus is mandatory to find incidental
 hiatal hernias and a complete dissection of the left crus performed to prevent retained
 fundus. The greater omentum was opened close to the stomach wall in some part in between the
 fundus and the antrum to have greater curvature completely detached from the stomach; this
 dissection starts at 2 cm or _____proximal to the pylorus and continued along the greater
 curvature to the left crus. Posterior adhesions if present, were carefully divided. The left
 gastrophrenic ligament was divided to expose the angle of His to identify the complete hiatus
 and fundus. A bougie was positioned before starting resection of the stomach. Researchers use
 a 36French bougie or --------- Researchers have chosen cartridges Black at the antrum level
 and finished with a purple cartridge. Researchers always checked the posterior wall before
 firing. Once Researchers have reached the proximal stomach, the stapler has to be positioned
 1 cm lateral to the left of the angle of His to avoid inclusion of esophageal tissue.
 Methylene blue test is performed routinely.

 2.8 Post-operative evaluation Regarding the primary endpoints, intraoperative complications
 (i.e. splenectomy, bleeding, positive leak test if performed) and type treatment are
 collected and recorded. Perioperative complications (<30 days) considered are mortality,
 morbidity (i.e. leak, bleeding, occlusion, pneumonia, vascular complications, portal
 pulmonary-splenic embolism) and type treatment. Postoperative complications (>30 days)
 considered are morbidity, mortality (i.e. leak, embolism, Incisional trocar hernia, other)
 and type treatment Regarding the secondary endpoint, in case of gastric fistula onset its
 diagnosis method (clinical, instrumental) and its management (timing, surgical or endoscopic
 - endoprosthesis, pigtails, clips-) or both) are collected and recorded. In case of
 postoperative bleeding, its diagnosis method (clinical, instrumental) and its management
 (timing, Surgical, medical) are collected and recorded.

 3.6 Statistical Analysis Continuous data are expressed as median and interquartile (25-75th)
 range or mean and Standard Deviation (SD), unless otherwise indicated. Differences between
 preoperative and postoperative parameters were compared by Wilcoxon paired rank test. Median
 time of follow-up was estimated using the Kaplan-Meier method. Multivariable analysis was
 conducted through a forward-backward stepwise Cox regression based on Akaike Information
 Criterion (AIC) considering age, gender, % Excess Weighth Loss, Body Mass Index and
 treatment.

 For all tests, the cut-off for statistical significance was set at p= 0.05. Statistical
 analysis was performed using R v3.5.0.
Inclusion Criteria:

 -  Morbid obesity defined as Body Mass Index 40 kg/m2

 -  Body Mass Index >35 with comorbidity (Type 2 Mellitus Diabetes (T2MD), hypertension,
 hyperlipidemia, bronchial asthma, osteoarthritis))

 -  Age between 25-68 years old.

 Exclusion Criteria:

 -  Patients with endocrine disorders causing obesity (as hypothyroidism and Cushing
 disease)

 -  Pregnancy or lactation

 -  Psychiatric illness

 -  Recent diagnosis of malignancy

 -  Inflammatory bowel disease

 -  Barrett ́s esophagus