Clinical trial NCT03465956: Laparoscopic Sleeve Gastrectomy Short Term Follow up
Official title: Laparoscopic Sleeve Gastrectomy Short Term Follow up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2018-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: TREATMENT

Brief 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. 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:

1. Complications:

   1. 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)
   2. 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.
2. 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.
3. Assessment of Blood Glucose level during visits.
4. Measurement of blood pressure during visits (if there is associated hypertension).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.
* Patients with age below 20 years or above 50 years.

Primary outcomes:
measure: Assessment of excess weight loss
timeFrame: First six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
affiliation: Assiut University
name: Mohamed Gamal
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.