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Omentopexy With Glubran®2 for Reducing Complications After Sleeve Gastrectomy

NCT03833232 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-02-08

No results posted yet for this study

Summary

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.

Conditions

  • Obesity With BMI >35

Interventions

DEVICE

omentopexy with cyanoacrilate glue

apposition of omentum with cyanoacrilate glue on gastric section

Sponsors & Collaborators

  • University of Salerno

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-04-30
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03833232 on ClinicalTrials.gov