NCT02538328

Brief Summary

Comparison of harmonic scalpel and ligasure devices in laparoscopic morbid obesity surgery especially in gastric bypass surgery patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 10, 2015

Last Update Submit

September 1, 2015

Conditions

Morbid Obesity

Keywords

laparoscopyobesityharmonic scalpelligasure

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of sealing

    Aim to compare the fogging and the time spend performing the gastric resection to form the gastric pouch.

    1 year

Secondary Outcomes (1)

  • Bleeding

    During the operation

Study Arms (2)

harmonic scapel

ACTIVE COMPARATOR

Obesity surgery cases where hamonic scalpel is used for the comparison of different surgical devices

Device: Harmonic scapelDevice: Ligasure

Ligasure sealing device

PLACEBO COMPARATOR

Ligasure used in obesity surgery for the comparison of different surgical devices Randomly chosen cases where ligasure is used instead of hamonic scalpel in surgical procedures comparison of multiple dissectors

Device: Harmonic scapelDevice: Ligasure

Interventions

Harmonic scapelDEVICE

different surgical devices used in the obesity surgery

Also known as: ultrasonic dissector
Ligasure sealing deviceharmonic scapel
LigasureDEVICE

Bipolar vessel sealing system used in obesity surgery

Also known as: Bipolar Vessel sealing device
Ligasure sealing deviceharmonic scapel

Eligibility Criteria

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

You may qualify if:

  • obesity
  • BMI over 40 kg/m\^2

You may not qualify if:

  • Normal BMI cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • cüneyt kayaalp, prof

    GENERAL SURGERY CHİEF OF GASTROİNTESTİNAL SURGERY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon in Gastrointestinal Surgery

Study Record Dates

First Submitted

August 10, 2015

First Posted

September 2, 2015

Study Start

July 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-08