Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue

Obesity, Morbid Clinical Trial

Official title: Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue: a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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.

A prospective cohort of consecutive patients underwent LSG was divided in two groups to compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. Type, location and features of the leak were described.

In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. How this may impact on clinical LSG outcomes needs further evaluations and was not the object of this study. ;

Related Conditions & MeSH terms

• Obesity, Morbid
• Rupture
• Suture Rupture
• Suture, Complication

• NCT number: NCT04488042
• Study type: Interventional
• Source: University of Campania "Luigi Vanvitelli"
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Completion date: June 30, 2020