Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery
Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
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
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2018
CompletedAugust 16, 2018
August 1, 2018
6 months
March 7, 2018
August 15, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
intraoperative maximum diameter of left lobe of the liver
intraoperative maximum diameter of left lobe of the liver in centimeter using intraoperative tape
4 hours
score of difficulty
score of difficulty from:exposure of the hiatus, retraction of the liver and operative time
6 hours
Secondary Outcomes (3)
operative time
6 hours
incidence of intraoperative complications
3 days
early postoperative complications
2 weeks
Study Arms (2)
preoperative left lobe measurement
EXPERIMENTALroutine preoperative left lobe measurement
Control group
ACTIVE COMPARATORControl group without routine measurement of left lobe
Interventions
Routine preoperative measurement of left lobe
Eligibility Criteria
You may qualify if:
- Morbidly obese patient with BMI more than 40 with or without co-morbidity
- Morbidly obese patient with BMI more than 35 with co-morbidity
You may not qualify if:
- Unfit patients for laparoscopy
- patients refuse to share in the study
- revisional surgery for obesity
- previous upper abdominal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Faculty of medicine
Minya, 61511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa M Sewefy
Minia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 7, 2018
First Posted
April 3, 2018
Study Start
February 1, 2018
Primary Completion
August 10, 2018
Study Completion
August 10, 2018
Last Updated
August 16, 2018
Record last verified: 2018-08