Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Deficiency After Bariatric Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04717973
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Farida Sami Abdou, Sohag University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 .

Condition or disease Intervention/treatment
Nutritional Deficiency Diagnostic Test: laboratory testing of CBC, serum ferritin, and vitamin B 12

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparison of Post-Operative Nutritional Deficiency Between Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Gastric Bypass
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • 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.

    Other Name: vitamin D and ionized serum calcium

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative [ Time Frame: From Jan 2021 to april 2021 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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 informedconsent; both written and verbal consent approved by the Sohag Ethics Committee will be taken from all patients included in the study postoperative.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717973


Contacts
Layout table for location contacts
Contact: Farida Sami, Master of Family Medicine 01096699664 farida.samy@med.sohag.edu.eg

Locations
Layout table for location information
Egypt
Farida sami abdou Recruiting
Sohag, Egypt
Contact: Farida Sami, Master of Family Medicine    01096699664    farida.samy@med.sohag.edu.eg   
Contact: Nesreen Mohammed, M.D    +20 101 7617763    Nesreenhammad180@yahoo.com   
Principal Investigator: Farida Sami, Master         
Sponsors and Collaborators
Sohag University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Farida Sami Abdou, assisstant lecturer of family medicine, Sohag University
ClinicalTrials.gov Identifier: NCT04717973    
Other Study ID Numbers: Soh-Med-21-01-08
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Vitamin B 12
Hydroxocobalamin
 Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Vitamin B Complex
Hematinics