Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery
July 27, 2020 updated by: Ahmad Namazov, Barzilai Medical Center
Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery: a Prospective Cohort Study
Ultrasound visceral slide test for prediction of periumbilical adhesions before gynecologic laparoscopic surgery: a prospective cohort study.
The investigators are planning to conduct a prospective study to evaluate if there is an effect of abdominal wall thickness and body mass index on slide distance of visceral organ during ultrasound examination.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ashkelon, Israel
- Barzilai University Medical Center
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
patients scheduled for elective laparoscopic surgery for any gynecologic indication.
Description
Inclusion Criteria:
- Patients scheduled for elective laparoscopic surgery for any gynecologic indication.
Exclusion Criteria:
- Emergency laparoscopic surgery
- Patients under age 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients scheduled for elective laparoscopic surgery
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Performing preoperative abdominal ultrasound examination in patients that will be scheduled for elective laparoscopic surgery for any gynecologic indication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visceral Slide Test
Time Frame: 2 minutes
|
correlation between abdominal wall thickness(mm) and sliding distance of visceral organ(mm) during ultrasound examination
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.
- Champault G, Cazacu F, Taffinder N. Serious trocar accidents in laparoscopic surgery: a French survey of 103,852 operations. Surg Laparosc Endosc. 1996 Oct;6(5):367-70.
- Chapron CM, Pierre F, Lacroix S, Querleu D, Lansac J, Dubuisson JB. Major vascular injuries during gynecologic laparoscopy. J Am Coll Surg. 1997 Nov;185(5):461-5.
- Fuller J, Ashar BS, Carey-Corrado J. Trocar-associated injuries and fatalities: an analysis of 1399 reports to the FDA. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):302-7. doi: 10.1016/j.jmig.2005.05.008.
- Brill AI, Nezhat F, Nezhat CH, Nezhat C. The incidence of adhesions after prior laparotomy: a laparoscopic appraisal. Obstet Gynecol. 1995 Feb;85(2):269-72. doi: 10.1016/0029-7844(94)00352-E.
- Levrant SG, Bieber EJ, Barnes RB. Anterior abdominal wall adhesions after laparotomy or laparoscopy. J Am Assoc Gynecol Laparosc. 1997 May;4(3):353-6. doi: 10.1016/s1074-3804(05)80227-0.
- Kodama I, Loiacono LA, Sigel B, Machi J, Golub RM, Parsons RE, Justin J, Zaren HA, Sachdeva AK. Ultrasonic detection of viscera slide as an indicator of abdominal wall adhesions. J Clin Ultrasound. 1992 Jul-Aug;20(6):375-80. doi: 10.1002/jcu.1870200603.
- Tu FF, Lamvu GM, Hartmann KE, Steege JF. Preoperative ultrasound to predict infraumbilical adhesions: a study of diagnostic accuracy. Am J Obstet Gynecol. 2005 Jan;192(1):74-9. doi: 10.1016/j.ajog.2004.07.034.
- Larciprete G, Valli E, Meloni P, Malandrenis I, Romanini ME, Jarvis S, Rossi F, Barbati G, Cirese E. Ultrasound detection of the "sliding viscera" sign promotes safer laparoscopy. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):445-9. doi: 10.1016/j.jmig.2009.03.023.
- Nezhat CH, Dun EC, Katz A, Wieser FA. Office visceral slide test compared with two perioperative tests for predicting periumbilical adhesions. Obstet Gynecol. 2014 May;123(5):1049-1056. doi: 10.1097/AOG.0000000000000239.
- Wilson A, Longhi J, Goldman C, McNatt S. Intra-abdominal pressure and the morbidly obese patients: the effect of body mass index. J Trauma. 2010 Jul;69(1):78-83. doi: 10.1097/TA.0b013e3181e05a79.
- Pelosi P, Quintel M, Malbrain ML. Effect of intra-abdominal pressure on respiratory mechanics. Acta Clin Belg. 2007;62 Suppl 1:78-88.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 11, 2019
Primary Completion (ACTUAL)
July 12, 2020
Study Completion (ACTUAL)
July 27, 2020
Study Registration Dates
First Submitted
August 12, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (ACTUAL)
August 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 29, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRZ 0024-18 CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.