NCT01784510

Brief Summary

Randomized controlled trial comparing between two technique of laparoscopic sleeve gastrectomy for treatment of morbid obesity. In the first technique the investigators started dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was only 2 cm. The main primary outcome measure was weight loss.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

First QC Date

February 2, 2013

Last Update Submit

February 5, 2013

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

    12 months postoperative

Study Arms (2)

2 cm

ACTIVE COMPARATOR
Procedure: distance of dissection of gastrocolic ligament from pylorus

6 cm

EXPERIMENTAL
Procedure: distance of dissection of gastrocolic ligament from pylorus

Interventions

distance of dissection of gastrocolic ligament from pylorusPROCEDURE
2 cm6 cm

Eligibility Criteria

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

You may qualify if:

  • morbid obesity with body mass index more than 40 or 35 with at least one comorbidity

You may not qualify if:

  • extreme of age less than 18 or over 65 years contraindications 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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of general surgery

Study Record Dates

First Submitted

February 2, 2013

First Posted

February 6, 2013

Primary Completion

January 1, 2013

Last Updated

February 6, 2013

Record last verified: 2013-02

Locations

EG(1)