NCT06882616

Brief Summary

The aim of this study was to compare carotid intima-media thicknesses in laparoscopic sleeve gastrectomy patients preoperatively and at the end of the first postoperative year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

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

Study Start

First participant enrolled

March 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 5, 2025

Last Update Submit

March 16, 2025

Conditions

Keywords

Carotis intima-media thicknessLaparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • carotid intima-media thickness

    The primary outcome of the study was to compare carotid intima-media thickness at the end of the first postoperative year after laparoscopic sleeve gastrectomy (LSG) with baseline carotid intima-media thickness in patients with obesity. The investigators will measure carotid intima-media thickness with carotid doppler ultrasound before LSG and at the end of the first year after LSG and compare the results.

    From enrollment to the end of the first year after laparoscopic sleeve gastrectomy

Study Arms (1)

laparoscopic sleeve gastrectomy

OTHER

laparoscopic sleeve gastrectomy

Other: surgery

Interventions

surgeryOTHER

All patients will be perform laparoscopic sleeve gastrectomy. Carotid intima-media thickness will be analyzed preoperatively and at the end of the first postoperative year.

laparoscopic sleeve gastrectomy

Eligibility Criteria

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

You may qualify if:

  • years old,
  • BMI \> 35 kg/m2
  • Laparoscopic sleeve gastrectomy will be performed
  • patients with cardiac disease

You may not qualify if:

  • patients without cardiac disease
  • patients who performed other bariatric surgery procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammed Taha Demirpolat

Istanbul, Umraniye, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammed Taha Demirpolat, Assoc. Prof.

    University of Health Sciences Umraniye Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Prospective, observational
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 18, 2025

Study Start

March 1, 2024

Primary Completion

April 1, 2024

Study Completion

March 1, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The investigators can share the results of statistical analysis

Locations