Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery
Sponsor
Barzilai Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03631888
Collaborator
(none)
80
1
17.5
4.6
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery: a Prospective Cohort Study
Actual Study Start Date
:
Feb 11, 2019
Actual Primary Completion Date
:
Jul 12, 2020
Actual Study Completion Date
:
Jul 27, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients scheduled for elective laparoscopic surgery
|
Diagnostic Test: preoperative abdominal ultrasound examination
Performing preoperative abdominal ultrasound examination in patients that will be scheduled for elective laparoscopic surgery for any gynecologic indication
|
Outcome Measures
Primary Outcome Measures
- Visceral Slide Test [2 minutes]
correlation between abdominal wall thickness(mm) and sliding distance of visceral organ(mm) during ultrasound examination
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients scheduled for elective laparoscopic surgery for any gynecologic indication.
Exclusion Criteria:
-
Emergency laparoscopic surgery
-
Patients under age 18
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barzilai University Medical Center | Ashkelon | Israel |
Sponsors and Collaborators
- Barzilai Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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. Review. Update in: Cochrane Database Syst Rev. 2015;8:CD006583.
- 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.
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- Pelosi P, Quintel M, Malbrain ML. Effect of intra-abdominal pressure on respiratory mechanics. Acta Clin Belg. 2007;62 Suppl 1:78-88.
- 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.
- 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.
Responsible Party:
Ahmad Namazov,
Principal investigator,
Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT03631888
Other Study ID Numbers:
- BRZ 0024-18 CTIL
First Posted:
Aug 15, 2018
Last Update Posted:
Jul 29, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: