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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Suture, Complication; Suture Rupture
• Intervention / Treatment: Other: Stapler-less gastrectomy; Other: Suture

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Claudio Gambardella

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stapler-less; 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.	Other: Stapler-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.
ACTIVE_COMPARATOR: Conventional Stapler; 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.	Other: Suture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Gianmattia del Genio, Prof, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (ACTUAL): July 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Sleeve gastrectomy; leaks; burst pressure; stapler-less
• Additional Relevant MeSH Terms: Wounds and Injuries; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Rupture; Obesity, Morbid
• Other Study ID Numbers: Stapler-less sleeve

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No