Laparoscopic Sleeve Gastrectomy Short Term Follow up

Morbid Obesity Clinical Trial

Official title:

Laparoscopic Sleeve Gastrectomy Short Term Follow up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03465956
• Other study ID #: Mohamed gamal
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2018
• Last updated: March 16, 2018
• Start date: April 2018
• Est. completion date: July 2020

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.

Locations

Country	Name	City	State
Egypt	AssiutU	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Mohamed Gamal Thabet	Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of excess weight loss	Assessment of excess weight loss six months after the operation.	First six months after surgery