Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

NCT ID: NCT03486691

Last Updated: 2018-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-08-10

Brief Summary

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the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty

Detailed Description

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the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the other group ultrasound not routinely done.

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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preoperative left lobe measurement

routine preoperative left lobe measurement

Group Type EXPERIMENTAL

Routine measurement of left lobe

Intervention Type OTHER

Routine preoperative measurement of left lobe

Control group

Control group without routine measurement of left lobe

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

no routine preoperative measurement of left lobe

Interventions

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Routine measurement of left lobe

Routine preoperative measurement of left lobe

Intervention Type OTHER

control group

no routine preoperative measurement of left lobe

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Morbidly obese patient with BMI more than 40 with or without co-morbidity
* Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria

* Unfit patients for laparoscopy
* patients refuse to share in the study
* revisional surgery for obesity
* previous upper abdominal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mstafa Hassan Sewefy

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa M Sewefy

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

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Faculty of medicine

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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fac.med.055

Identifier Type: -

Identifier Source: org_study_id

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