Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery

Periumbilical Adhesions Clinical Trial

Official title:

Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631888
• Other study ID #: BRZ 0024-18 CTIL
• Status: Completed
• Start date: February 11, 2019
• Est. completion date: July 27, 2020

Study information

• Verified date: July 2020
• Source: Barzilai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 27, 2020
• Est. primary completion date: July 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective laparoscopic surgery for any gynecologic indication.

Exclusion Criteria:

• Emergency laparoscopic surgery

• Patients under age 18

Related Conditions & MeSH terms

• Periumbilical Adhesions
• Tissue Adhesions

Intervention

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

Locations

Country	Name	City	State
Israel	Barzilai University Medical Center	Ashkelon

Sponsors (1)

Lead Sponsor	Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):1049-56. doi: 10.1097/AOG.0000000000000239. — View Citation

Pelosi P, Quintel M, Malbrain ML. Effect of intra-abdominal pressure on respiratory mechanics. Acta Clin Belg. 2007;62 Suppl 1:78-88. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral Slide Test	correlation between abdominal wall thickness(mm) and sliding distance of visceral organ(mm) during ultrasound examination	2 minutes