NCT02976649

Brief Summary

The purpose of this study is to propose a multi-dimensional score to predict those patients undergoing bariatric surgeries who will be in need for postoperative ICU admission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 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, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

November 22, 2016

Last Update Submit

July 26, 2019

Conditions

Bariatric Surgery Procedures

Keywords

Morbid obesityBariatric surgeryMulti-dimensional score

Outcome Measures

Primary Outcomes (1)

  • Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission

    Through study completion, an average of six months.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbid obese patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass.

You may qualify if:

  • patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass during the period from January to June 2016.

You may not qualify if:

  • Patients were excluded in case of postoperative surgical complications, conversion to open surgery or in case of redo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Walid H. Nofal, MD

    Anesthesiology department, Faculty of Medicine, Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 29, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations

EG(1)