Robotic Versus Laparoscopic Roux En-y Gastric Bypass

Obesity, Morbid Clinical Trial

Official title:

Can Robotic Gastric Bypass be Considered a Valid Alternative to Laparoscopy: Our Early Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05746936
• Other study ID #: 7
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: February 2023
• Source: University of Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study retrospectively identified 33 consecutive obese patients who underwent either laparoscopic or robotic gastric bypass procedures over a 2-year period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 15, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) =35-39 kg/m2 with one obesity- associated co-morbidity

• BMI=40kg/m2, age = 18 years.

Exclusion Criteria:

• Re-do surgery procedures

Related Conditions & MeSH terms

• Anastomosis; Complications
• Bypass Complication
• Obesity, Morbid
• Roux-en-y Anastomosis Site

Intervention

Procedure:
• Roux en-Y gastric bypass
gastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis

Locations

Country	Name	City	State
Italy	University of Foggia	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences between the robotic and laparoscopic gastric bypass	incidence of mortality and morbidity (percentage)	two years period
Primary	differences between the robotic and laparoscopic gastric bypass	BMI ( kg/m2)	two years period
Primary	differences between the robotic and laparoscopic gastric bypass	age (years)	two years period
Primary	differences between the robotic and laparoscopic gastric bypass	weight (kg)	two years period