Obesity, Morbid Clinical Trial
Official title:
Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue: a Randomized Controlled Trial
Verified date | July 2020 |
Source | University of Campania "Luigi Vanvitelli" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Morbid obesity according to IFSO guidelines Exclusion Criteria: - Gastric specimen with injury and/or electrocoagulation signs at serosa - Presence of comorbidities capable of affecting specimen tissue resistance (i.e. type II diabetes, gastric ulcer, connective tissue disease, systemic sclerosis, polymyositis) |
Country | Name | City | State |
---|---|---|---|
Italy | Claudio Gambardella | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Campania "Luigi Vanvitelli" |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastric specimen tissue resistance | Evaluate the manometric burst pressure in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2) | During procedure | |
Primary | Gastric specimen volume resistance | the saline volume needed to determine a gastric leak in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2) | During procedure |
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