NCT04683666

Brief Summary

A prospective, observational study of all morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) was performed. We evaluated preoperative comorbidities and cardiovascular risk factors, and the appearance of postoperative complications up to 90 days after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

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

March 15, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

5.5 years

First QC Date

December 21, 2020

Last Update Submit

December 21, 2020

Conditions

Complication of Surgical Procedure

Outcome Measures

Primary Outcomes (2)

  • Medical complications

    Medical complications include cardiovascular complications (new onset or impairment of acute heart infarction, arrhythmias, cardiac failure or stroke), respiratory complications (pneumonia or respiratory failure) and acute renal failure.

    90 days after surgery

  • Septic complications

    Septic complications include, urinary tract infections, incisional or organ/space surgical site infection (SSI), pneumonia or bacteriemia of other origin.

    90 days after surgery

Interventions

Bariatric surgeryPROCEDURE

Laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), as primary bariatric procedures, were performed. \^Postoperative complications were assessed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients included were morbidly obese patients or patients with severe obesity associated with obesity-related comorbidities

You may qualify if:

  • BMI \>40 Kg/m2
  • BMI \>35 Kg/m2 associated with obesity-related comorbidities

You may not qualify if:

  • ASA IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Asuncion Acosta

    Hospital Universitario Dr Negrin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 24, 2020

Study Start

March 15, 2013

Primary Completion

September 1, 2018

Study Completion

June 15, 2020

Last Updated

December 24, 2020

Record last verified: 2020-12