NCT01974388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
Last Updated

November 23, 2015

Status Verified

January 1, 2008

Enrollment Period

4 years

First QC Date

October 26, 2013

Last Update Submit

November 20, 2015

Conditions

Obesity

Keywords

Bariatric surgery, sleeve gastrectomy, gastric leak

Outcome Measures

Primary Outcomes (1)

  • percent of excess weight loss

    The percent of EWL was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] Ă—100.

    one year postoperative

Secondary Outcomes (4)

  • length of postoperative stay

    30 days

  • postoperative complications

    one year postoperative

  • weight regain

    one year postoperative

  • Resolution of comorbidity

    one year postoperative

Study Arms (2)

LSG started 2 cm from the pylorus

ACTIVE COMPARATOR

laparoscopic sleeve gastrectomy starting 2 cm from the pylorus

Procedure: LSG started 2 cm from the pylorus

LSG started 6 cm from pylorus

ACTIVE COMPARATOR

LSG started 6 cm from pylorus

Procedure: LSG started 6 cm from pylorus

Interventions

LSG started 2 cm from the pylorusPROCEDURE

Laparoscopic sleeve gastrectomy started 2 cm from pylorus

Also known as: Group I
LSG started 2 cm from the pylorus
LSG started 6 cm from pylorusPROCEDURE

LSG started 6 cm from pylorus

Also known as: Group II
LSG started 6 cm from pylorus

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG)

You may not qualify if:

  • patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman El Nakeeb

Al Mansurah, Mansoura, 35111, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 21861236RESULT

  • 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.

    PMID: 20730606RESULT

  • 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.

    PMID: 20379795RESULT

  • 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.

    PMID: 19572113RESULT

  • 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.

    PMID: 24728866DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayman El Nakeeb, MD

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

October 26, 2013

First Posted

November 1, 2013

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 23, 2015

Record last verified: 2008-01

Locations

EG(1)