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Completed

NCT Number: NCT04488042

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

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Suture Rupture Suture, Complication

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Claudio Gambardella

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stapler-less gastrectomy

Other

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.

Suture

Other

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.

Primary outcomes

  1. Gastric specimen tissue resistance

    Time frame: 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)

  2. Gastric specimen volume resistance

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2020
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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