NCT03240367

Brief Summary

Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.

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 Dec 2016

Shorter than P25 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

December 4, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
Last Updated

August 7, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

July 14, 2017

Last Update Submit

August 4, 2017

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • 3-item drainage control

    Bleeding quantities to be noted

    8 months

Study Arms (2)

coutery

EXPERIMENTAL

Stapler bloom will be stopped with cautery

Other: Coutery

clips

NO INTERVENTION

Stapler bloom will be stopped with clipping

Interventions

CouteryOTHER

Stapler line bleeding control with coutery

coutery

Eligibility Criteria

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

You may qualify if:

  • Morbid obese patients

You may not qualify if:

  • Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44915, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ersin Gündoğan, MD

    study principal investigator

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
operator doctor

Study Record Dates

First Submitted

July 14, 2017

First Posted

August 7, 2017

Study Start

December 4, 2016

Primary Completion

July 14, 2017

Study Completion

July 14, 2017

Last Updated

August 7, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)