NCT04717973

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

January 16, 2021

Last Update Submit

August 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative

    From Jan 2021 to april 2021

Study Arms (2)

patients undergo sleeve gasterectomy

Diagnostic Test: laboratory testing of CBC, serum ferritin, and vitamin B 12

patients undergo gasteric bypass

Diagnostic Test: laboratory testing of CBC, serum ferritin, and vitamin B 12

Interventions

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.

Also known as: vitamin D and ionized serum calcium
patients undergo gasteric bypasspatients undergo sleeve gasterectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age from 18 to 65.
  • BMI more than 40 and more than 30 with co morbidities
  • Both sexes with history of failed weight loss attempts in the past for two years and good motivation for surgery.

You may not qualify if:

  • Age less than 18, more than 65.
  • Revisional bariatric surgery.
  • Previous gastric surgery
  • Patients with endocrinal disturbance except hypothyroidism and DM
  • Psychological disturbed patients
  • Females during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farida sami abdou

Sohag, Egypt

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer of family medicine

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 22, 2021

Study Start

January 5, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations