Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Other: control group; Other: Routine measurement of left lobe

• Registration Number: NCT03486691
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-04-01
• Study First Posted: 2018-04-03
• Status Verified: 2018-08
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	control group	Control group without routine measurement of left lobe
preoperative left lobe measurement	Routine measurement of left lobe	routine preoperative left lobe measurement

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Minya, Egypt