Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT01550601 - Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity N/A
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Recruiting NCT05711758 - Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Not yet recruiting NCT04209842 - Effectiveness Gastric Balloon in Obese Adolescents N/A
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02590406 - EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation N/A
Completed NCT01840020 - BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Completed NCT01183975 - Swedish Adjustable Gastric Banding Observational Cohort Study N/A
Completed NCT03872024 - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients N/A
Terminated NCT05993169 - Body Composition Optimization Intervention RCT N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Recruiting NCT05554016 - The UFO (Ultra Processed Foods in Obesity) Project
Not yet recruiting NCT05499949 - The Franciscus Obesity NASH Study
Completed NCT05519423 - Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals N/A