Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy (LSG)
Impact of Extent of Antral Resection on Surgical Outcomes of Sleeve Gastrectomy for Morbid Obesity (A Prospective Randomized Study)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mansoura, Egypt, 35111
- Ayman El Nakeeb
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: LSG started 2 cm from the pylorus
laparoscopic sleeve gastrectomy starting 2 cm from the pylorus
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Laparoscopic sleeve gastrectomy started 2 cm from pylorus
Other Names:
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Active Comparator: LSG started 6 cm from pylorus
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LSG started 6 cm from pylorus
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percent of excess weight loss
Time Frame: one year postoperative
|
The percent of EWL was calculated as follows: [(preoperative weight-follow up weight)/preoperative excess weight] ×100.
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one year postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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length of postoperative stay
Time Frame: 30 days
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length of postoperative stay
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30 days
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postoperative complications
Time Frame: one year postoperative
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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)
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one year postoperative
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weight regain
Time Frame: one year postoperative
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an increase of body weight of more than 10 kg from the nadir
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one year postoperative
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Resolution of comorbidity
Time Frame: one year postoperative
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Resolution of comorbidity was considered if the disease is controlled without any medications.
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one year postoperative
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ferrer-Marquez M, Belda-Lozano R, Ferrer-Ayza M. Technical controversies in laparoscopic sleeve gastrectomy. Obes Surg. 2012 Jan;22(1):182-7. doi: 10.1007/s11695-011-0492-0.
- Pomerri F, Foletto M, Allegro G, Bernante P, Prevedello L, Muzzio PC. Laparoscopic sleeve gastrectomy--radiological assessment of fundus size and sleeve voiding. Obes Surg. 2011 Jul;21(7):858-63. doi: 10.1007/s11695-010-0255-3.
- Shi X, Karmali S, Sharma AM, Birch DW. A review of laparoscopic sleeve gastrectomy for morbid obesity. Obes Surg. 2010 Aug;20(8):1171-7. doi: 10.1007/s11695-010-0145-8.
- Sanchez-Santos R, Masdevall C, Baltasar A, Martinez-Blazquez C, Garcia Ruiz de Gordejuela A, Ponsi E, Sanchez-Pernaute A, Vesperinas G, Del Castillo D, Bombuy E, Duran-Escribano C, Ortega L, Ruiz de Adana JC, Baltar J, Maruri I, Garcia-Blazquez E, Torres A. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg. 2009 Sep;19(9):1203-10. doi: 10.1007/s11695-009-9892-9. Epub 2009 Jul 2.
- Abdallah E, El Nakeeb A, Youssef T, Abdallah H, Ellatif MA, Lotfy A, Youssef M, Elganash A, Moatamed A, Morshed M, Farid M. Impact of extent of antral resection on surgical outcomes of sleeve gastrectomy for morbid obesity (a prospective randomized study). Obes Surg. 2014 Oct;24(10):1587-94. doi: 10.1007/s11695-014-1242-x. Erratum In: Obes Surg. 2015 Oct;25(10):1987. Yousef, Tamer [Corrected to Youssef, Tamer].
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Morbid Obesity
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