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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04717973
Other study ID # Soh-Med-21-01-08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2021
Est. completion date January 1, 2022

Study information

Verified date August 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

comparing micro-nutrient deficiencies in postoperative morbid obese patients who will be undergoing gastric bypass and sleeve gastrectomy with regards to vit B 12, vitamin D,iron studies and calcium .


Description:

The General surgery department will be reviewed for a period of six months duration. All patients who admitted to the department and subjected to laparoscopic GP and SG during the study period will be included in the study after securing an informed consent; both written and verbal consent approved by the Sohag Ethics Committee will be taken from all patients included in the study. Patients will be followed for one year by laboratory testing of CBC, serum ferritin, and vitamin B 12, vitamin D and ionized serum calcium after the 1st month, 3rd month, 6th month, and then after one year postoperative. The pre-operative and post-operative measures will be compared in patients who will be subjected to Laparoscopic Sleeve Gastrectomy versus Laparoscopic Gastric Bypass.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age from 18 to 65. 2. BMI more than 40 and more than 30 with co morbidities 3. Both sexes with history of failed weight loss attempts in the past for two years and good motivation for surgery. Exclusion Criteria: 1. Age less than 18, more than 65. 2. Revisional bariatric surgery. 3. Previous gastric surgery 4. Patients with endocrinal disturbance except hypothyroidism and DM 5. Psychological disturbed patients 6. Females during pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
laboratory testing of CBC, serum ferritin, and vitamin B 12
laboratory testing of CBC, serum ferritin, and vitamin B 12, vitamin D and ionized serum calcium after the 1st month, 3rd month, 6th month, and then after one year postoperative. The pre-operative and post-operative measures will be compared in patients who will be subjected to Laparoscopic Sleeve Gastrectomy versus Laparoscopic Gastric Bypass.

Locations

Country Name City State
Egypt Farida sami abdou Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative From Jan 2021 to april 2021
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