NCT05746936

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

February 2, 2023

Last Update Submit

February 23, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • differences between the robotic and laparoscopic gastric bypass

    incidence of mortality and morbidity (percentage)

    two years period

  • differences between the robotic and laparoscopic gastric bypass

    BMI ( kg/m2)

    two years period

  • differences between the robotic and laparoscopic gastric bypass

    age (years)

    two years period

  • differences between the robotic and laparoscopic gastric bypass

    weight (kg)

    two years period

Study Arms (2)

Obese patients underwent laparoscopic gastric bypass

Procedure: Roux en-Y gastric bypass

obese patients underwent robotic gastric bypass

Procedure: Roux en-Y gastric bypass

Interventions

gastric bypass with jejuna-jenual anastomosis and gusto-jejunal anastomosis

Obese patients underwent laparoscopic gastric bypassobese patients underwent robotic gastric bypass

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized psychological and physical evaluation which includes blood chemistry tests, chest x-rays, electrocardiogram and cardiological examinations, nutritional evaluation, esophagogastroduodenoscopy, spirometry and psychiatric evaluation .

You may qualify if:

  • Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity
  • BMI≥40kg/m2, age ≥ 18 years.

You may not qualify if:

  • Re-do surgery procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Foggia

Foggia, 71122, Italy

Location

Related Publications (1)

  • Pavone G, Pacilli M, Gerundo A, Quazzico A, Ambrosi A, Tartaglia N. Can robotic gastric bypass be considered a valid alternative to laparoscopy? Our early experience and literature review. Front Surg. 2024 Feb 5;11:1303351. doi: 10.3389/fsurg.2024.1303351. eCollection 2024.

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 28, 2023

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

January 15, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations