Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486691
• Other study ID #: fac.med.055
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 10, 2018

Study information

• Verified date: August 2018
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Other:
• Routine measurement of left lobe
Routine preoperative measurement of left lobe
• control group
no routine preoperative measurement of left lobe

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	score of difficulty	score of difficulty from:exposure of the hiatus, retraction of the liver and operative time	6 hours
Secondary	operative time	operative time from skin to skin	6 hours
Secondary	incidence of intraoperative complications	incidence of intraoperative complications like bleeding,or injury to intra-abdominal organ	3 days
Secondary	early postoperative complications	early postoperative complications like leak or vomiting	2 weeks