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Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Routine measurement of left lobe
control group
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

preoperative left lobe measurement

Control group

Arm Description

routine preoperative left lobe measurement

Control group without routine measurement of left lobe

Outcomes

Primary Outcome Measures

intraoperative maximum diameter of left lobe of the liver
intraoperative maximum diameter of left lobe of the liver in centimeter using intraoperative tape
score of difficulty
score of difficulty from:exposure of the hiatus, retraction of the liver and operative time

Secondary Outcome Measures

operative time
operative time from skin to skin
incidence of intraoperative complications
incidence of intraoperative complications like bleeding,or injury to intra-abdominal organ
early postoperative complications
early postoperative complications like leak or vomiting

Full Information

First Posted
March 7, 2018
Last Updated
August 15, 2018
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT03486691
Brief Title
Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery
Official Title
Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preoperative left lobe measurement
Arm Type
Experimental
Arm Description
routine preoperative left lobe measurement
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group without routine measurement of left lobe
Intervention Type
Other
Intervention Name(s)
Routine measurement of left lobe
Intervention Description
Routine preoperative measurement of left lobe
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
no routine preoperative measurement of left lobe
Primary Outcome Measure Information:
Title
intraoperative maximum diameter of left lobe of the liver
Description
intraoperative maximum diameter of left lobe of the liver in centimeter using intraoperative tape
Time Frame
4 hours
Title
score of difficulty
Description
score of difficulty from:exposure of the hiatus, retraction of the liver and operative time
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
operative time
Description
operative time from skin to skin
Time Frame
6 hours
Title
incidence of intraoperative complications
Description
incidence of intraoperative complications like bleeding,or injury to intra-abdominal organ
Time Frame
3 days
Title
early postoperative complications
Description
early postoperative complications like leak or vomiting
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M Sewefy
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt

12. IPD Sharing Statement

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Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

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