Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression

Not Applicable

Not yet recruiting

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06859320
• Lead Sponsor: Zagazig University

Brief Summary

Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. But, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study Start: 2025-03-01
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• obese patients with depression and hypothyroidism controlled by medical treatment candidate for sleeve gastrectomy

Exclusion Criteria

• patients less than 18 or above 60
• other psychiatric or medical disorders.
• patients not fit for surgery
• un controlled patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
thyroid function tests	from one day to one year after surgery	TSH,T3,T4 are measured pre and post operative
depression	from one day to one year after surgery	depression status is compared pre-operative and post-operative using depression questionnaire (PHQ-9)( patient health questionnaire-9)
weight	from one day to one year after surgery	weight of the patient will be measured in Kg using weight scale
dose of thyroid replacement therapy	monthly from one day to one year post surgery.	the dose of L-thyroxin is monitored in microgrames
gasteric leakage	from one day to 1 week post-surgery	leakage after surgery from staple line measured in ml in the drain
wound infection	from one day to 2 weeks post-surgery	wound infection will be identified by pus in the drain or in the wound

Secondary Outcome Measures

Name	Time	Method
age	2 days pre-operative	age will be measured in years
sex	2 days pre-operative	sex of patient (male or female) will be recorded before surgery
BMI ( Body Mass Index)	2 days before surgery to one year after surgery	BMI is measured by the sum of weight in kg divided by the squared height in meters

Trial Locations

Locations (2)

Faculty of Medicine; 🇪🇬 Zagazig, Sharqia, Egypt

Zagazig University Hospitals; 🇪🇬 Zagazig, Egypt