NCT03231423

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 is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

December 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

July 12, 2017

Last Update Submit

July 26, 2017

Conditions

Obesity, Morbid

Keywords

ObesityVASPainLaparoscopyBypass

Outcome Measures

Primary Outcomes (1)

  • 3-Item Pain Intensity measyre (P3)

    self reported pain intensity morning, second day and third day. Each item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)

    8 months

Study Arms (2)

DRAIN PLACEMENT

EXPERIMENTAL

Effects of drainage

Other: Drainage

DRAIN NOT PLACED

NO INTERVENTION

Effects of not using drain

Interventions

DrainageOTHER

Using drain after operation

DRAIN PLACEMENT

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) were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, MorbidObesityPain

Interventions

Drainage

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 27, 2017

Study Start

December 9, 2016

Primary Completion

June 22, 2017

Study Completion

June 22, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share