Obesity
Conditions
Keywords
Bariatric surgery, sleeve gastrectomy, gastric leak
Brief summary
Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by both restrictive and hormonal action. Consecutive patients with morbid obesity treated by LSG at our department were evaluated. Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.
Detailed description
This prospective randomized study was designed to compare between the beginning of sleeve gastrectomy 2 cm versus 6 cm from the pylorus with special regards to intraoperative problems, weight loss, improvement of comorbidities, postoperative complications, nutritional and elemental deficiencies. Consecutive patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG) at the department of general surgery, Mansoura University, Egypt, during the period from January 2008 to January 2012, were eligible for the study. The exclusion criteria included patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse. The operation was done under general anesthesia. Patient was in supine position with splitting of the operating table legs.Gastric transection started 2 cm proximal to the pylorus using 60 mm, green endo-stapler (Ethicon, USA) (GI) or 6 cm from the pylorus (G II). The following staplers were placed approximately 1 cm from the bougie in the direction of the gastroesophageal junction. Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.
Interventions
PROCEDURELSG started 2 cm from the pylorus
Laparoscopic sleeve gastrectomy started 2 cm from pylorus
PROCEDURELSG started 6 cm from pylorus
LSG started 6 cm from pylorus
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG)
Exclusion criteria
* patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percent of excess weight loss | one year postoperative | The percent of EWL was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of postoperative stay | 30 days | length of postoperative stay |
| postoperative complications | one year postoperative | gastric leakage, internal haemorrhage, pulmonary complications). Complications were graded according to their severity on a validated five point scale using Dindo-Clavien complication classification system) into (grades I, II, IIIa-b, IVa-b, V). Grade I (no need for specific intervention), grade II (need for drug therapy such antibiotics, blood transfusion, total parenteral nutrition), grade IIIa-b (need for invasive therapy radiological, endoscopic or surgical), grade IVa-b (organ dysfunction requiring ICU stay and management), grade V (death) |
| weight regain | one year postoperative | an increase of body weight of more than 10 kg from the nadir |
| Resolution of comorbidity | one year postoperative | Resolution of comorbidity was considered if the disease is controlled without any medications. |
Countries
Egypt
Outcome results
None listed