NCT01846637

Brief Summary

The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

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

June 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

2.8 years

First QC Date

February 10, 2013

Last Update Submit

May 2, 2013

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • percentage of excess weight loss

    2 years

Secondary Outcomes (1)

  • complications

    2 years

Other Outcomes (1)

  • improvement of comorbidities

    2 years

Study Arms (2)

2 cm from pylorus

EXPERIMENTAL

at laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus.

Procedure: laparoscopic sleeve gastrectomy

6 cm from pylorus

ACTIVE COMPARATOR

at laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus

Procedure: laparoscopic sleeve gastrectomy

Interventions

laparoscopic sleeve gastrectomyPROCEDURE
2 cm from pylorus6 cm from pylorus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • morbid obese patients

You may not qualify if:

  • contraindication to laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Surgical Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of general surgery

Study Record Dates

First Submitted

February 10, 2013

First Posted

May 3, 2013

Study Start

June 1, 2010

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

EG(1)