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NCT Number: NCT06859320

Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Zagazig, Sharqia Province, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

laparoscopic sleeve gastrectomy is one of the popular bariatric surgeries known for weight reduction

Primary outcomes

  1. thyroid function tests

    Time frame: from one day to one year after surgery

    TSH,T3,T4 are measured pre and post operative

  2. depression

    Time frame: 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)

  3. weight

    Time frame: from one day to one year after surgery

    weight of the patient will be measured in Kg using weight scale

  4. dose of thyroid replacement therapy

    Time frame: monthly from one day to one year post surgery.

    the dose of L-thyroxin is monitored in microgrames

  5. gasteric leakage

    Time frame: from one day to 1 week post-surgery

    leakage after surgery from staple line measured in ml in the drain

  6. wound infection

    Time frame: from one day to 2 weeks post-surgery

    wound infection will be identified by pus in the drain or in the wound

Secondary outcomes

  1. age

    Time frame: 2 days pre-operative

    age will be measured in years

  2. sex

    Time frame: 2 days pre-operative

    sex of patient (male or female) will be recorded before surgery

  3. BMI ( Body Mass Index)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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