NCT03983122

Brief Summary

The aim of this study is to assess 5 year long-term outcomes of laparoscopic sleeve gastrectomy emphasizing weight loss and modification of comorbidities such as type 2 diabetes mellitus, hypertension and gastroesophageal reflux disease from a developing country, Turkey. Prospectively-collected patient data will retrospectively reviewed. To measure the efficacy of the procedure, we will calculate the excess weight loss percentage (EWL %). Effective weight loss after LSG will accepted as more than 50%. The changes in the status of the type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease will be observed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

May 25, 2019

Last Update Submit

June 10, 2019

Conditions

Bariatric Surgery CandidateLaparoscopic Sleeve GastrectomyObesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Weight loss after surgery

    5 years

Secondary Outcomes (1)

  • Remision of comorbid diseases

    5 years

Study Arms (1)

Study group

EXPERIMENTAL

Patients who undergo laparoscopic sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomy

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

Each procedure will be completed with laparoscopy with five trocars. A 36F bougie will used to calibrate the volume of the remnant stomach. Linear gastrectomy will begin 2 cm proximal of the pylor and will continue until the gastroesophageal junction. According to the intraoperative decision and experience of the surgeon, endoscopic clips would be used to ensure hemostasis of the stapler line.

Study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2019

First Posted

June 12, 2019

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2018

Last Updated

June 12, 2019

Record last verified: 2019-06