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CompletedNCT03983122Updated Jun 12, 2019

Outcomes of Laparoscopic Sleeve Gastrectomy

An interventional study of Laparoscopic sleeve gastrectomy in Bariatric Surgery Candidate, Laparoscopic Sleeve Gastrectomy and Obesity, Morbid, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-12.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 9 months after the study started (first participant enrolled Aug 2012, registered May 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bariatric Surgery Candidate
  • Laparoscopic Sleeve Gastrectomy
  • Obesity, Morbid

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03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's enrollment of 120 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Inclusion criteria were, patients between 18 to 65 years old, initial body mass index (BMI) 40 kg/m2 or BMI of 35 kg/m2 in the presence of additional comorbidity and failure of conservative treatment for 2 years.

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Study group

    Patients who undergo laparoscopic sleeve gastrectomy

    Procedure: Laparoscopic sleeve gastrectomy

Interventions

  • ProcedureLaparoscopic sleeve gastrectomy

    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.

06

What researchers measure

Primary outcomes

  1. Weight loss

    Weight loss after surgery

    Time frame: 5 years

Secondary outcomes

  1. Remision of comorbid diseases

    The pharmacological treatment status of comorbidities related to obesity of type 2 diabetes (T2DM) and hypertension and gastroesophageal reflux will be observed with questions about "did it stop after surgery (improvement), did the dose or number of medications used reduce (resolution), or were there no changes?"

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03983122
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible party
Hakan Seyit (Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Principal investigator
First posted
Jun 12, 2019
Start date
Aug 1, 2012
Primary completion
Dec 1, 2013
Completion
Dec 1, 2018
Last update
Jun 12, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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