NCT02068014

Brief Summary

Sleev gastrectomy is a procedure performed for permanent treatment of obesity. For the procedure, cutting of the stomach is performed with differents long of stapplers. The aim of the study is to determine wich long of stappler is applicable in any stage of the procedure ans the variation expected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

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

First Submitted

Initial submission to the registry

February 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

February 19, 2014

Last Update Submit

March 28, 2016

Conditions

Obesity

Keywords

stapplers- obesity- stomach

Outcome Measures

Primary Outcomes (1)

  • differences in wall mesurments

    during 3 month the data will be collected and proceceed

    3 month

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients underwnt laparoscopic sleev gastrectomy between 18 y.o. and 70 y.o.

You may qualify if:

  • every laparoscopic sleeve gastrectomy
  • between 18 y.o. and 70 y.o.
  • no previous gastric operation

You may not qualify if:

  • under 18 y.o. or over 70 y.o. previous gastric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta MC

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 20, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

IL(1)