Morbid ObesityNCT03465956
Laparoscopic Sleeve Gastrectomy Short Term Follow up
A study testing Laparoscopic Sleeve Gastrectomy in people with Morbid Obesity, run by Mohamed Gamal Thabet at 1 site in Egypt.
Trial summary
Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy. LSG was initially considered a first-stage operation in high-risk patients before bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2018to Jul 2020
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity), and are fit for laparoscopic surgery.
Who cannot join
- Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.
- Patients with age below 20 years or above 50 years.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AssiutU
Asyut
Mohamed Gamal, 01026674177, gamal.m53@yahoo.com
About this study
Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy.
LSG was initially considered a first-stage operation in high-risk patients before bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. However, LSG was subsequently found to be effective as a single procedure for treatment of morbid obesity.LSG functions mainly as a restrictive procedure in which about 75 % of the stomach is removed leaving a narrow gastric tube or sleeve. So, it limits the amount of food that can be eaten at one time via inducing early satiety after eating a small amount of food due to early distension of the fashioned gastric sleeve giving a sense of satiety, consequently losing excess body weight by time.Sleeve gastrectomy may also cause a decrease in appetite by reducing the amount of Ghrelin (hunger hormone) produced by the stomach.
Read the detailed description
All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity) randomly admitted to Assiut University Hospital-General Surgery Department.
Pre-operative: Assessment of; BMI (Body Mass Index), Fasting Blood Glucose level (FBG), Associated Co-morbidities (as hypertensions \& sleep apnea).
Operative (During Operation):
All patients undergo LSG by single team work with intra-operative oesophageal bougie 36 french with use of laparoscopic gastro-intestinal anastomosis(GIA) stapler.
Post-operative:
Patients are discharged from the hospital after they can start oral diet.
Post-operative evaluation of:
- Complications:
- Early complications: during the first 2 weeks after surgery,which include hemorrhage (intra-luminal or extra-luminal), staple line leak, vomiting and infection (surgical site infection or intra- abdominal abscess formation)
- Late complications: from 2 weeks to 6 months post-operative, which include stricture of the gastric sleeve, gastro-esophageal reflux disease (GERD) and nutritional deficiencies.
- Excess weight loss (EWL) by using BMI Follow up of patients at fifteen days, one month, two months, three months and six months after surgery.
- Assessment of Blood Glucose level during visits.
- Measurement of blood pressure during visits (if there is associated hypertension).
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopic Sleeve Gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Other | Laparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler. Receives: Procedure: Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of excess weight loss
Assessment of excess weight loss six months after the operation.
Measured: First six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \> 35 kg/m2 associated with co-morbidity).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Gamal Thabet
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Mohamed Gamal Thabet, Assiut University
- Investigators
- Mohamed Gamal, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465956
- Sponsor's protocol ID
- Mohamed gamal
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nosso G, Angrisani L, Saldalamacchia G, Cutolo PP, Cotugno M, Lupoli R, Vitolo G, Capaldo B. Impact of sleeve gastrectomy on weight loss, glucose homeostasis, and comorbidities in severely obese type 2 diabetic subjects. J Obes. 2011;2011:340867. doi: 10.1155/2011/340867. Epub 2011 Mar 8.
PubMed 21423553
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sleeve Gastrectomy Short Term Follow up
- ClinicalTrials.gov ID
- NCT03465956
- Acronym / sponsor ID
- Mohamed gamal
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mohamed Gamal ThabetUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Apr 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 15 Mar 2018 (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.
Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy.
LSG was initially considered a first-stage operation in high-risk patients before bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. However, LSG was subsequently found to be effective as a single procedure for treatment of morbid obesity.LSG functions mainly as a restrictive procedure in which about 75 % of the stomach is removed leaving a narrow gastric tube or sleeve. So, it limits the amount of food that can be eaten at one time via inducing early satiety after eating a small amount of food due to early distension of the fashioned gastric sleeve giving a sense of satiety, consequently losing excess body weight by time.Sleeve gastrectomy may also cause a decrease in appetite by reducing the amount of Ghrelin (hunger hormone) produced by the stomach.
Detailed description
All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity) randomly admitted to Assiut University Hospital-General Surgery Department.
Pre-operative: Assessment of; BMI (Body Mass Index), Fasting Blood Glucose level (FBG), Associated Co-morbidities (as hypertensions \& sleep apnea).
Operative (During Operation):
All patients undergo LSG by single team work with intra-operative oesophageal bougie 36 french with use of laparoscopic gastro-intestinal anastomosis(GIA) stapler.
Post-operative:
Patients are discharged from the hospital after they can start oral diet.
Post-operative evaluation of:
- Complications:
- Early complications: during the first 2 weeks after surgery,which include hemorrhage (intra-luminal or extra-luminal), staple line leak, vomiting and infection (surgical site infection or intra- abdominal abscess formation)
- Late complications: from 2 weeks to 6 months post-operative, which include stricture of the gastric sleeve, gastro-esophageal reflux disease (GERD) and nutritional deficiencies.
- Excess weight loss (EWL) by using BMI Follow up of patients at fifteen days, one month, two months, three months and six months after surgery.
- Assessment of Blood Glucose level during visits.
- Measurement of blood pressure during visits (if there is associated hypertension).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity).
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Other | Procedure: Laparoscopic Sleeve GastrectomyLaparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity), and are fit for laparoscopic surgery.
Key exclusion criteria (2 listed)
- Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.
- Patients with age below 20 years or above 50 years.
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 |
|---|---|---|
| Laparoscopic Sleeve GastrectomyLaparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler. | Procedure or surgery | Laparoscopic Sleeve Gastrectomy |
Primary outcome
Assessment of excess weight loss
Time frame: First six months after surgery
Assessment of excess weight loss six months after the operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: PubMed 21423553Nosso G, Angrisani L, Saldalamacchia G, Cutolo PP, Cotugno M, Lupoli R, Vitolo G, Capaldo B. Impact of sleeve gastrectomy on weight loss, glucose homeostasis, and comorbidities in severely obese type 2 diabetic subjects. J Obes. 2011;2011:340867. doi: 10.1155/2011/340867. Epub 2011 Mar 8.
- 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.
Mohamed Gamal principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Sleeve Gastrectomy in people with Morbid Obesity, run by Mohamed Gamal Thabet 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of excess weight loss (time frame: First six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465956, which also lists 1 linked publication.
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 20 Mar 2018.