NCT03088683

Brief Summary

In Laparoscopic Sleeve Gastrectomy, retraction of the left lobe of the liver is important for an effective visualisation. There are many retractors available for this retraction. A study is designed to compare two different liver retractors for liver trauma; Nathanson liver retractor that is used more commonly and Reveel liver retractor that has more recent history of use.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

January 16, 2017

Last Update Submit

March 16, 2017

Conditions

Obesity

Keywords

sleeve gastrectomyliver retractornathansonreveelliver trauma

Outcome Measures

Primary Outcomes (1)

  • Changes in physiological parameters of liver due to trauma of retractors

    Traumatic effects of liver retractors in sleeve gastrectomy. Number of participants with abnormal laboratory values.

    within the first 2 days of the surgery

Study Arms (2)

Nathanson Retractor

ACTIVE COMPARATOR

Nathanson retractor will be used

Device: Nathanson Retractor

Reveel Retractor

ACTIVE COMPARATOR

Reveel retractor will be used

Device: Reveel Retractor

Interventions

Nathanson RetractorDEVICE

Liver will be retracted with Nathanson retractor

Nathanson Retractor
Reveel RetractorDEVICE

Liver will be retracted with Reveel retractor

Reveel Retractor

Eligibility Criteria

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

You may qualify if:

  • patients with BMI\>35

You may not qualify if:

  • patients with known liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nazif Bagriacik Kadioy Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Abdullah Sisik

    Umraniye Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah Sisik

CONTACT

00905062623325abdullahsisik@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgery Specialist

Study Record Dates

First Submitted

January 16, 2017

First Posted

March 23, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 20, 2017

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

TU(1)