Omentopexy With Glubran®2 for Reducing Complications After Sleeve Gastrectomy
Omentopexy With Glubran®2 for Reducing Complications After Sleeve Gastrectomy
BACKGROUND. Gastric fistulas, bleeding, and strictures are commonly reported after
 laparoscopic sleeve gastrectomy (LSG), that increase morbidity and hospital stay and may put
 the patient's life at risk. This trial reports our prospective evaluation of application of
 synthetic sealant, a modified cyanoacrylate (Glubran®2), on suture rime, associated with
 omentopexy, to identify results on LSG-related complications.

 METHODS. Patients were enrolled for LSG by two Bariatric Centers, with high-level activity
 volume. Intraoperative recorded parameters were: operative time, estimated intraoperative
 bleeding, conversion rate. Presence of early complications after LSG during the follow up
 period was evaluated. Overall complications were analyzed. Perioperative data and weight loss
 were also evaluated. A control group was identified for the study.
The prospective randomized trial is designed with the aim to verify the effectiveness of the
 Glubran®2 used in its spray application, according to manufacturer's indications, to perform
 the omentopexy of the staple line to prevent and reduce early complications after LSG.
 single-blind randomization was explained: a single surgeon, in enrollment phase, assigned
 patient to case or control group, after adequate communication of randomization to all
 patients. The surgeon that performed procedure only knew if patient was randomized to case
 group (LSG with omentopexy with Glubran®2) or to control group (LSG without omentopexy with
 Glubran®2). Control group was identified for the study with simple randomization, considering
 patients treated with LSG during same period. Patients of case and control groups were not
 paired. Same recording was performed for both groups. Patients were enrolled for LSG by two
 Bariatric Centers, with high-level activity volume, after multidisciplinary evaluation:
 inclusion criteria, according with international guidelines, was body mass index (BMI) of
 greater than 40 kg/m2 or > 35 with at least one co-morbidity, such as hypertension,
 dyslipidemia or diabetes, age ≥ 18 years old, medically unfit for surgical intervention,
 absence of active gastric disease, of uncontrolled medical or psychiatric conditions, and
 signed informed consent. Bariatric procedure was performed according with standardized
 four-trocars technique. All surgeons involved had a proved experience for bariatric surgery,
 and have completed learning curve.

 The size of the boogie to be used for calibration ranged from 42 to 48 Fr, among two groups.
 In case group, after gastric partition and confirming correct closure of mechanical section
 (performed with Endo-Gia, varying depth of stapler, from 3.5 mm blue to 4.4 black charge,
 according with gastric level), a layer of the synthetic sealant on all rime suture was
 applied and an omentum flap to place was apposed. Absence of gastric rotation with omentum
 flap, or any tension on the resected stomach was carefully controlled. In control group, we
 reinforced staple line with buttressing (bovine pericardium) of mechanical stapler, or with
 running suture of the rime alone, indifferently. A recording of type of reinforcing was
 performed, also if not pertinent to study.

 Anthropometric data recorded were: age, weight, BMI, presence of comorbidities.
 Intraoperative recorded parameters were: operative time, estimated intraoperative bleeding
 (in ml), conversion rate. We prospectively evaluated the presence of early complications
 after LSG during the follow up period (30 days from intervention). Considered complications
 were staple line leakage/gastric fistula, postoperative bleeding, intraabdominal abscess,
 cardiopulmonary failure, and all other complications. In order to considering effects and
 real impact of mentioned events, we also evaluated length of hospital stay, rate of
 readmission, rate of reintervention, overall mortality at 30 days. Weight loss was recorded
 at 15 and 30 days, as excess weight loss percent (EWL%) and as reduction of BMI.

 The demographic data and perioperative data were compared using the student's t and Mann-
 Whitney U tests for continuous variables. Fisher's exact test was used to determine any
 statistical significance for the categorical variables. The continuous variables were
 presented as mean ± standard deviation and the categorical variables were presented as the
 number (%). The level of significance was set at 0.05.

 All procedures involving human participants were in accordance with the Ethical standards of
 the institutional research committee and with the 1964 Helsinki declaration and its later
 amendments.
Inclusion Criteria:

 -  body mass index (BMI) of greater than 40 kg/m2 or > 35 with at least one co-morbidity,
 such as hypertension, dyslipidemia or diabetes,

 -  age ≥ 18 years old,

 -  medically unfit for surgical

 -  absence of active gastric disease, of uncontrolled medical or psychiatric conditions,

 -  signed informed consent.

 Exlusion criteria

 - patient not suitable for bariatric surgery