Obesity, Morbid, Suture, Complication, Suture Rupture
Conditions
Keywords
Sleeve gastrectomy, stapler-less, burst pressure, leaks
Brief 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.
Detailed 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.
Interventions
OTHERStapler-less gastrectomy
After the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.
OTHERSuture
No reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Physicians who performed manometry were blinded from specimen allocation
Intervention model description
the gastric specimen were immediately randomly allocated to the two groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric specimen tissue resistance | During procedure | Evaluate the manometric burst pressure in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2) |
| Gastric specimen volume resistance | During procedure | 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) |
Countries
Italy
Outcome results
None listed