Standarization for Stappler Application During Sleeve Gastrectomy

Obesity Clinical Trial

— LSG  

Official title:

Implication and Factors Influencing the Decision to Select Srapplers During Laparoscopic Sleeve Gastrectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068014
• Other study ID #: SA012014
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: March 28, 2016
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Assuta Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Helsinski commitee assuta medical center
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

After permormed laparoscopic sleeve gastrectomy the stonach retrieved for pathology study will be messured in three ponts: antrum, body and fundus.

In each point medition of the two walls and any wall (anterior and posterior) will be messurd.

Those data will be stariscally analized to perform a applicable guidelines for stapller selection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• every laparoscopic sleeve gastrectomy

• between 18 y.o. and 70 y.o.

• no previous gastric operation

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Israel	Assuta MC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in wall mesurments	during 3 month the data will be collected and proceceed	3 month	Yes