Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy
NCT ID: NCT01974388
Last Updated: 2015-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2008-01-31
2012-01-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LSG started 2 cm from the pylorus
laparoscopic sleeve gastrectomy starting 2 cm from the pylorus
LSG started 2 cm from the pylorus
Laparoscopic sleeve gastrectomy started 2 cm from pylorus
LSG started 6 cm from pylorus
LSG started 6 cm from pylorus
LSG started 6 cm from pylorus
LSG started 6 cm from pylorus
Interventions
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LSG started 2 cm from the pylorus
Laparoscopic sleeve gastrectomy started 2 cm from pylorus
LSG started 6 cm from pylorus
LSG started 6 cm from pylorus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ayman El Nakeeb
Ass. Prof.
Principal Investigators
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Ayman El Nakeeb, MD
Role: STUDY_DIRECTOR
Mansoura University
Locations
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Ayman El Nakeeb
Al Mansurah, Mansoura, Egypt
Countries
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References
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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.
Related Links
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Mansoura university, Mansoura, Egypt
Other Identifiers
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Morbid Obesity
Identifier Type: -
Identifier Source: org_study_id