Outcomes of Laparoscopic Sleeve Gastrectomy

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03983122
• Collaborator: (none)
• Enrollment: 120
• Arm: 1
• Actual Duration (Months): 76

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate; Laparoscopic Sleeve Gastrectomy; Obesity, Morbid	Procedure: Laparoscopic sleeve gastrectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long Term Outcomes of Laparoscopic Sleeve Gastrectomy: First Five Years' Results of a Single Center From a Developing Country
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Study group Patients who undergo laparoscopic sleeve gastrectomy

Procedure: Laparoscopic 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.

Outcome Measures

Primary Outcome Measures

1. Weight loss [5 years]

   Weight loss after surgery

Secondary Outcome Measures

1. Remision of comorbid diseases [5 years]

   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?"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hakan Seyit, Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT03983122
• Other Study ID Numbers: BakirkoySKGeneralSurgery
• First Posted: Jun 12, 2019
• Last Update Posted: Jun 12, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity, Morbid

Study Results

No Results Posted as of Jun 12, 2019