Nutritional DeficiencyNCT04717973
Nutritional Deficiency After Bariatric Surgeries
An observational study of Nutritional Deficiency, run by Sohag University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- laboratory testing of CBC, serum ferritin, and vitamin B 12
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Nutritional Deficiency
- Being tested
- laboratory testing of CBC, serum ferritin, and vitamin B 12
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory testing of CBC, serum ferritin, and vitamin B 12Diagnostic test
Also called vitamin D and ionized serum calcium
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 group | Role | What they receive |
|---|---|---|
| patients undergo sleeve gasterectomy | Not described Receives: Diagnostic Test: laboratory testing of CBC, serum ferritin, and vitamin B 12 | |
| patients undergo gasteric bypass | Not described Receives: Diagnostic Test: laboratory testing of CBC, serum ferritin, and vitamin B 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative
Measured: From Jan 2021 to april 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start5 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farida Sami Abdou, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717973
- Sponsor's protocol ID
- Soh-Med-21-01-08
- Status last verified
- Aug 2022
- First submitted
- 16 Jan 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Operative Nutritional Deficiency Between Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Gastric Bypass
- ClinicalTrials.gov ID
- NCT04717973
- Acronym / sponsor ID
- Soh-Med-21-01-08
- Conditions
- Nutritional Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Age less than 18, more than 65.
- Revisional bariatric surgery.
- Previous gastric surgery
- Patients with endocrinal disturbance except hypothyroidism and DM
- Psychological disturbed patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory testing of CBC, serum ferritin, and vitamin B 12Also: vitamin D and ionized serum calciumlaboratory 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. | Diagnostic test | patients undergo gasteric bypass, patients undergo sleeve gasterectomy |
Primary outcome
the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative
Time frame: From Jan 2021 to april 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Deficiency, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative (time frame: From Jan 2021 to april 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.