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Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03486691
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Alaa Mstafa Hassan Sewefy, 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

Condition or disease Intervention/treatment Phase
Obesity, Morbid Other: Routine measurement of left lobe Other: control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 10, 2018
Actual Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. score of difficulty [ Time Frame: 6 hours ]
    score of difficulty from:exposure of the hiatus, retraction of the liver and operative time


Secondary Outcome Measures :
  1. operative time [ Time Frame: 6 hours ]
    operative time from skin to skin

  2. incidence of intraoperative complications [ Time Frame: 3 days ]
    incidence of intraoperative complications like bleeding,or injury to intra-abdominal organ

  3. early postoperative complications [ Time Frame: 2 weeks ]
    early postoperative complications like leak or vomiting



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486691


Locations
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Egypt
Faculty of medicine
Minya, Egypt, 61511
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Alaa M Sewefy Minia University

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Responsible Party: Alaa Mstafa Hassan Sewefy, Assistant professor, Minia University
ClinicalTrials.gov Identifier: NCT03486691     History of Changes
Other Study ID Numbers: fac.med.055
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms