NCT06859320

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 14, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 27, 2025

Last Update Submit

August 12, 2025

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

obesityhypothyroidismDepression

Outcome Measures

Primary Outcomes (6)

  • thyroid function tests

    TSH,T3,T4 are measured pre and post operative

    from one day to one year after surgery

  • depression

    depression status is compared pre-operative and post-operative using depression questionnaire (PHQ-9)( patient health questionnaire-9)

    from one day to one year after surgery

  • weight

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

    from one day to one year after surgery

  • dose of thyroid replacement therapy

    the dose of L-thyroxin is monitored in microgrames

    monthly from one day to one year post surgery.

  • gasteric leakage

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

    from one day to 1 week post-surgery

  • wound infection

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

    from one day to 2 weeks post-surgery

Secondary Outcomes (3)

  • age

    2 days pre-operative

  • sex

    2 days pre-operative

  • BMI ( Body Mass Index)

    2 days before surgery to one year after surgery

Study Arms (1)

morbid obesity and overweight in patients with hypothyroidism and depression

OTHER
Procedure: laparoscopic sleeve gastrectomy

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

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

morbid obesity and overweight in patients with hypothyroidism and depression

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

Zagazig University Hospitals

Zagazig, 44519, Egypt

Location

MeSH Terms

Conditions

ObesityHypothyroidismDepression

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThyroid DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of general surgery, faculty of medicine, Zagazig University, Egypt.

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

August 14, 2025

Record last verified: 2025-02

Locations

EG(2)