ObesityNCT06664099
Comparison of Weight Loss and Nutritional Deficiency After One Anastomosis Gastric Bypass at 150, 170, and 200 cm From the Duodenojejunal Junction
A study testing One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction), One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction) and One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction) in people with Obesity and Nutritional Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
This study is a randomized clinical trial comparing the effects of One Anastomosis Gastric Bypass performed at three different distances from the duodenojejunal junction-150 centimeters, 170 centimeters, and 200 centimeters-on weight loss outcomes and nutritional status in patients with obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Nutritional Deficiency, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction), One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction) and One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2023to 20 Jun 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 60 years.
- Body Mass Index (BMI) of 35 kg/m² or higher, or BMI of 30 kg/m² or higher with significant obesity-related comorbidities.
- Failed adequate conservative management (diet, exercise, and/or medication) for at least 6 months.
- Demonstrated psychological stability and motivation for surgery.
- Acceptance of the surgical risks associated with bariatric procedures.
Who cannot join
- Prior abdominal exploratory surgery.
- Previous bariatric surgery.
- Pre-existing significant nutritional deficiencies.
- Pregnancy or current lactation.
- Severe, long-standing cardiac or pulmonary disease or other serious systemic illnesses.
- Active substance or alcohol abuse.
- Active gastric ulcer disease.
- Psychological instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between One Anastomosis Gastric Bypass (OAGB) at Different Lengths of 150, 170, and 200 cm From the Duodenojejunal Junction Regarding Weight Loss and Nutritional Deficiency
This study is a randomized clinical trial comparing the effects of One Anastomosis Gastric Bypass performed at three different distances from the duodenojejunal junction-150 centimeters, 170 centimeters, and 200 centimeters-on weight loss outcomes and nutritional status in patients with obesity. One Anastomosis Gastric Bypass is a type of bariatric surgery that combines aspects of a gastric sleeve and a traditional gastric bypass, aiming to achieve effective weight loss and improvement in health conditions associated with obesity.
The study will include 60 adult patients between 18 and 60 years old with a Body Mass Index of 35 kilograms per square meter or greater, or a Body Mass Index of 30 kilograms per square meter or greater with obesity-related health conditions, who have not achieved adequate results through diet, exercise, or medication. Participants will be randomly assigned to one of three groups, each undergoing One Anastomosis Gastric Bypass with a different limb length from the duodenojejunal junction: 150 centimeters, 170 centimeters, or 200 centimeters.
Read more
The primary outcomes measured will include the percentage of total weight loss, the percentage of excess weight loss, and postoperative nutritional status, particularly in terms of levels of albumin, calcium, iron, and ferritin. Secondary outcomes will assess the remission of health conditions related to obesity, including high blood pressure and type 2 diabetes mellitus, as well as patient quality of life following surgery.
By examining the impact of One Anastomosis Gastric Bypass at varying limb lengths on weight loss and nutritional deficiencies, this study aims to identify an optimal surgical approach that balances effective weight management and minimizes the risk of postoperative malnutrition. The findings will inform surgical decision-making and postoperative management strategies for individuals undergoing One Anastomosis Gastric Bypass.
- Conditions
- Obesity, Nutritional Deficiency, Type 2 Diabetes Mellitus (T2DM), Bariatric Surgery (Gastric Bypass)
- Being tested
- One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction), One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction), One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)
- Keywords
- One Anastomosis Gastric Bypass, Duodenojejunal Junction, Weight Loss Surgery, Bariatric Surgery, Nutritional Deficiency, Obesity Treatment, Postoperative Nutrition
- Medical subject headings
- Obesity, Malnutrition, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction)Procedure or surgery
This intervention involves performing a One Anastomosis Gastric Bypass surgery with the bypassed length of the small intestine set at 150 centimeters from the duodenojejunal junction. This shorter limb length is designed to achieve weight loss while potentially reducing the risk of nutritional deficiencies. The procedure is performed laparoscopically, with the stomach divided to create a gastric tube attached to a loop of the small intestine. Postoperative outcomes will include assessments of weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers such as albumin, calcium, and iron.
One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction)Procedure or surgery
This intervention involves performing a One Anastomosis Gastric Bypass surgery with a bypassed length of 170 centimeters from the duodenojejunal junction, offering an intermediate limb length. This distance is intended to balance weight loss effectiveness with moderate risks of nutritional deficiencies. The laparoscopic procedure involves creating a gastric tube attached to a segment of the small intestine, bypassing the proximal portion. Outcomes monitored postoperatively include weight loss, percentage of total and excess weight loss, and nutritional parameters such as albumin, calcium, and iron levels.
One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)Procedure or surgery
This intervention consists of performing a One Anastomosis Gastric Bypass with the bypass length set at 200 centimeters from the duodenojejunal junction. This longer bypass length is designed to maximize weight loss outcomes but may carry a higher risk of nutritional deficiencies. The procedure is done laparoscopically, where the stomach is divided, creating a tube that is joined to the small intestine at the specified length. Postoperative assessments will focus on weight loss effectiveness, total and excess weight loss percentages, and the risk of nutritional deficiencies by measuring markers such as albumin, calcium, and iron.
| Study group | Role | What they receive |
|---|---|---|
| One Anastomosis Gastric Bypass at 150 cm from Duodenojejunal Junction | Experimental | Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 150 centimeters from the duodenojejunal junction. This approach aims to achieve weight loss while potentially minimizing nutritional deficiencies by utilizing a shorter bypass length. Postoperative outcomes will be monitored, focusing on weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers such as albumin, calcium, and iron levels. Receives: Procedure: One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction) |
| One Anastomosis Gastric Bypass at 170 cm from Duodenojejunal Junction | Experimental | Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 170 centimeters from the duodenojejunal junction. This approach aims to balance effective weight loss and nutritional outcomes with an intermediate limb length. Postoperative outcomes will include measurements of weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers, such as albumin, calcium, and iron levels. Receives: Procedure: One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction) |
| One Anastomosis Gastric Bypass at 200 cm from Duodenojejunal Junction | Experimental | Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 200 centimeters from the duodenojejunal junction. This approach prioritizes maximizing weight loss but may carry a higher risk of nutritional deficiencies due to the longer bypass length. Postoperative outcomes will be evaluated for weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers, including albumin, calcium, and iron levels. Receives: Procedure: One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Total Weight Loss
This outcome measures the percentage of total weight loss achieved by participants one year after undergoing One Anastomosis Gastric Bypass at specified lengths (150 cm, 170 cm, or 200 cm from the duodenojejunal junction). Total weight loss is calculated as the percentage change in body weight from the initial weight measured preoperatively. This measure provides insight into the effectiveness of different bypass lengths in achieving weight loss in patients with obesity.
Measured: 12 months post-surgery
Incidence of Nutritional Deficiency in Albumin
This outcome measures the incidence of albumin deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Albumin deficiency is defined as serum albumin levels below 3.0 g/dL, indicating a risk of protein malnutrition. This outcome will help assess the nutritional impact of different bypass lengths.
Measured: 12 months post-surgery
Incidence of Nutritional Deficiency in Calcium
This outcome measures the incidence of calcium deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Calcium deficiency is defined as serum calcium levels below 8.5 mg/dL, which can indicate a risk of bone health complications and overall nutritional deficiency. This measure will evaluate the impact of different bypass lengths on calcium levels.
Measured: 12 months post-surgery
Incidence of Nutritional Deficiency in Iron
This outcome measures the incidence of iron deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Iron deficiency is defined as serum iron levels below 50 µg/dL, indicating a risk of anemia and associated health complications. This outcome will help assess the influence of different bypass lengths on iron absorption and nutritional status.
Measured: 12 months post-surgery
Secondary outcomes (2)
Remission Rate of Type 2 Diabetes Mellitus
This outcome measures the rate of remission of type 2 diabetes mellitus in participants one year after undergoing One Anastomosis Gastric Bypass surgery at different limb lengths (150 cm, 170 cm, or 200 cm from the duodenojejunal junction). Remission of diabetes is defined as achieving a fasting blood glucose level below 126 mg/dL and an HbA1c level below 6.5% without the use of antidiabetic medication. This outcome will evaluate the impact of bypass length on diabetes remission.
Measured: 12 months post-surgery
Improvement in Hypertension
This outcome measures the improvement rate of hypertension among participants one year after undergoing One Anastomosis Gastric Bypass at varying lengths from the duodenojejunal junction. Improvement is defined as maintaining blood pressure below 135/85 mm Hg without the use of antihypertensive medications. This outcome will help assess the effectiveness of the surgery at different limb lengths in managing blood pressure levels.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start20 Jun 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel design to compare the outcomes of One Anastomosis Gastric Bypass at three different distances (150 cm, 170 cm, and 200 cm) from the duodenojejunal junction in separate groups to assess weight loss and nutritional deficiency.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelkarem Ahmed Abdelkarem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664099
- Sponsor's protocol ID
- MD-123-2023
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that will be shared includes de-identified data related to primary and secondary outcomes, specifically data on weight loss measures, incidence of nutritional deficiencies, and remission rates of comorbidities (type 2 diabetes and hypertension).
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between One Anastomosis Gastric Bypass (OAGB) at Different Lengths of 150, 170, and 200 cm From the Duodenojejunal Junction Regarding Weight Loss and Nutritional Deficiency
- ClinicalTrials.gov ID
- NCT06664099
- Acronym / sponsor ID
- MD-123-2023
- Conditions
- Obesity, Nutritional Deficiency, Type 2 Diabetes Mellitus (T2DM), Bariatric Surgery (Gastric Bypass)
- Keywords
- One Anastomosis Gastric Bypass, Duodenojejunal Junction, Weight Loss Surgery, Bariatric Surgery, Nutritional Deficiency, Obesity Treatment, Postoperative Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 29 Oct 2024 (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.
This study is a randomized clinical trial comparing the effects of One Anastomosis Gastric Bypass performed at three different distances from the duodenojejunal junction-150 centimeters, 170 centimeters, and 200 centimeters-on weight loss outcomes and nutritional status in patients with obesity. One Anastomosis Gastric Bypass is a type of bariatric surgery that combines aspects of a gastric sleeve and a traditional gastric bypass, aiming to achieve effective weight loss and improvement in health conditions associated with obesity.
The study will include 60 adult patients between 18 and 60 years old with a Body Mass Index of 35 kilograms per square meter or greater, or a Body Mass Index of 30 kilograms per square meter or greater with obesity-related health conditions, who have not achieved adequate results through diet, exercise, or medication. Participants will be randomly assigned to one of three groups, each undergoing One Anastomosis Gastric Bypass with a different limb length from the duodenojejunal junction: 150 centimeters, 170 centimeters, or 200 centimeters.
The primary outcomes measured will include the percentage of total weight loss, the percentage of excess weight loss, and postoperative nutritional status, particularly in terms of levels of albumin, calcium, iron, and ferritin. Secondary outcomes will assess the remission of health conditions related to obesity, including high blood pressure and type 2 diabetes mellitus, as well as patient quality of life following surgery.
By examining the impact of One Anastomosis Gastric Bypass at varying limb lengths on weight loss and nutritional deficiencies, this study aims to identify an optimal surgical approach that balances effective weight management and minimizes the risk of postoperative malnutrition. The findings will inform surgical decision-making and postoperative management strategies for individuals undergoing One Anastomosis Gastric Bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study uses a parallel design to compare the outcomes of One Anastomosis Gastric Bypass at three different distances (150 cm, 170 cm, and 200 cm) from the duodenojejunal junction in separate groups to assess weight loss and nutritional deficiency.
| Arm | Type | Receives |
|---|---|---|
| One Anastomosis Gastric Bypass at 150 cm from Duodenojejunal Junction | Experimental | Procedure: One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction)Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 150 centimeters from the duodenojejunal junction. This approach aims to achieve weight loss while potentially minimizing nutritional deficiencies by utilizing a shorter bypass length. Postoperative outcomes will be monitored, focusing on weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers such as albumin, calcium, and iron levels. |
| One Anastomosis Gastric Bypass at 170 cm from Duodenojejunal Junction | Experimental | Procedure: One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction)Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 170 centimeters from the duodenojejunal junction. This approach aims to balance effective weight loss and nutritional outcomes with an intermediate limb length. Postoperative outcomes will include measurements of weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers, such as albumin, calcium, and iron levels. |
| One Anastomosis Gastric Bypass at 200 cm from Duodenojejunal Junction | Experimental | Procedure: One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)Participants in this arm will undergo One Anastomosis Gastric Bypass surgery with the bypass performed at a distance of 200 centimeters from the duodenojejunal junction. This approach prioritizes maximizing weight loss but may carry a higher risk of nutritional deficiencies due to the longer bypass length. Postoperative outcomes will be evaluated for weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers, including albumin, calcium, and iron levels. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 60 years.
- Body Mass Index (BMI) of 35 kg/m² or higher, or BMI of 30 kg/m² or higher with significant obesity-related comorbidities.
- Failed adequate conservative management (diet, exercise, and/or medication) for at least 6 months.
- Demonstrated psychological stability and motivation for surgery.
- Acceptance of the surgical risks associated with bariatric procedures.
Key exclusion criteria (8 listed)
- Prior abdominal exploratory surgery.
- Previous bariatric surgery.
- Pre-existing significant nutritional deficiencies.
- Pregnancy or current lactation.
- Severe, long-standing cardiac or pulmonary disease or other serious systemic illnesses.
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 |
|---|---|---|
| One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction)This intervention involves performing a One Anastomosis Gastric Bypass surgery with the bypassed length of the small intestine set at 150 centimeters from the duodenojejunal junction. This shorter limb length is designed to achieve weight loss while potentially reducing the risk of nutritional deficiencies. The procedure is performed laparoscopically, with the stomach divided to create a gastric tube attached to a loop of the small intestine. Postoperative outcomes will include assessments of weight loss, total weight loss percentage, excess weight loss percentage, and nutritional markers such as albumin, calcium, and iron. | Procedure or surgery | One Anastomosis Gastric Bypass at 150 cm from Duodenojejunal Junction |
| One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction)This intervention involves performing a One Anastomosis Gastric Bypass surgery with a bypassed length of 170 centimeters from the duodenojejunal junction, offering an intermediate limb length. This distance is intended to balance weight loss effectiveness with moderate risks of nutritional deficiencies. The laparoscopic procedure involves creating a gastric tube attached to a segment of the small intestine, bypassing the proximal portion. Outcomes monitored postoperatively include weight loss, percentage of total and excess weight loss, and nutritional parameters such as albumin, calcium, and iron levels. | Procedure or surgery | One Anastomosis Gastric Bypass at 170 cm from Duodenojejunal Junction |
| One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction)This intervention consists of performing a One Anastomosis Gastric Bypass with the bypass length set at 200 centimeters from the duodenojejunal junction. This longer bypass length is designed to maximize weight loss outcomes but may carry a higher risk of nutritional deficiencies. The procedure is done laparoscopically, where the stomach is divided, creating a tube that is joined to the small intestine at the specified length. Postoperative assessments will focus on weight loss effectiveness, total and excess weight loss percentages, and the risk of nutritional deficiencies by measuring markers such as albumin, calcium, and iron. | Procedure or surgery | One Anastomosis Gastric Bypass at 200 cm from Duodenojejunal Junction |
Primary outcome
Percentage of Total Weight Loss
Time frame: 12 months post-surgery
This outcome measures the percentage of total weight loss achieved by participants one year after undergoing One Anastomosis Gastric Bypass at specified lengths (150 cm, 170 cm, or 200 cm from the duodenojejunal junction). Total weight loss is calculated as the percentage change in body weight from the initial weight measured preoperatively. This measure provides insight into the effectiveness of different bypass lengths in achieving weight loss in patients with obesity.
Incidence of Nutritional Deficiency in Albumin
Time frame: 12 months post-surgery
This outcome measures the incidence of albumin deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Albumin deficiency is defined as serum albumin levels below 3.0 g/dL, indicating a risk of protein malnutrition. This outcome will help assess the nutritional impact of different bypass lengths.
Incidence of Nutritional Deficiency in Calcium
Time frame: 12 months post-surgery
This outcome measures the incidence of calcium deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Calcium deficiency is defined as serum calcium levels below 8.5 mg/dL, which can indicate a risk of bone health complications and overall nutritional deficiency. This measure will evaluate the impact of different bypass lengths on calcium levels.
Incidence of Nutritional Deficiency in Iron
Time frame: 12 months post-surgery
This outcome measures the incidence of iron deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Iron deficiency is defined as serum iron levels below 50 µg/dL, indicating a risk of anemia and associated health complications. This outcome will help assess the influence of different bypass lengths on iron absorption and nutritional status.
2 secondary outcomes
Remission Rate of Type 2 Diabetes Mellitus
Time frame: 12 months post-surgery
Improvement in Hypertension
Time frame: 12 months post-surgery
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 12 Nov 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that will be shared includes de-identified data related to primary and secondary outcomes, specifically data on weight loss measures, incidence of nutritional deficiencies, and remission rates of comorbidities (type 2 diabetes and hypertension).
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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?
A study testing One Anastomosis Gastric Bypass (150 cm from Duodenojejunal Junction), One Anastomosis Gastric Bypass (170 cm from Duodenojejunal Junction) and One Anastomosis Gastric Bypass (200 cm from Duodenojejunal Junction) in people with Obesity and Nutritional Deficiency, run by Cairo 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 5 inclusion and 8 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 12 Nov 2024. 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?
Percentage of Total Weight Loss (time frame: 12 months post-surgery). The study lists 4 primary outcomes in all. 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 12 Nov 2024.