Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

August 15, 2018 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preoperative left lobe measurement
routine preoperative left lobe measurement
Other: Routine measurement of left lobe
Routine preoperative measurement of left lobe
Active Comparator: Control group
Control group without routine measurement of left lobe
Other: control group
no routine preoperative measurement of left lobe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative maximum diameter of left lobe of the liver
Time Frame: 4 hours
intraoperative maximum diameter of left lobe of the liver in centimeter using intraoperative tape
4 hours
score of difficulty
Time Frame: 6 hours
score of difficulty from:exposure of the hiatus, retraction of the liver and operative time
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 6 hours
operative time from skin to skin
6 hours
incidence of intraoperative complications
Time Frame: 3 days
incidence of intraoperative complications like bleeding,or injury to intra-abdominal organ
3 days
early postoperative complications
Time Frame: 2 weeks
early postoperative complications like leak or vomiting
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

August 10, 2018

Study Completion (Actual)

August 10, 2018

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

April 1, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med.055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity, Morbid

Clinical Trials on Routine measurement of left lobe

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe