Nutritional Deficiency After Bariatric Surgeries

Comparison of Post-Operative Nutritional Deficiency Between Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Gastric Bypass

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 .

Study Overview

• Status: Completed
• Conditions: Nutritional Deficiency
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Farida sami abdou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients undergo sleeve gasterectomy	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 Names: vitamin D and ionized serum calcium
patients undergo gasteric bypass	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 Names: vitamin D and ionized serum calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative	From Jan 2021 to april 2021

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Vitamin B Complex; Hematinics; Vitamin D; Vitamins; Vitamin B 12; Hydroxocobalamin
• Other Study ID Numbers: Soh-Med-21-01-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No