NCT03631888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

August 12, 2018

Last Update Submit

July 27, 2020

Conditions

Periumbilical Adhesions

Outcome Measures

Primary Outcomes (1)

  • Visceral Slide Test

    correlation between abdominal wall thickness(mm) and sliding distance of visceral organ(mm) during ultrasound examination

    2 minutes

Study Arms (1)

patients scheduled for elective laparoscopic surgery

Diagnostic Test: preoperative abdominal ultrasound examination

Interventions

preoperative abdominal ultrasound examinationDIAGNOSTIC_TEST

Performing preoperative abdominal ultrasound examination in patients that will be scheduled for elective laparoscopic surgery for any gynecologic indication

patients scheduled for elective laparoscopic surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients scheduled for elective laparoscopic surgery for any gynecologic indication.

You may qualify if:

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

You may not qualify if:

  • Emergency laparoscopic surgery
  • Patients under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai University Medical Center

Ashkelon, Israel

Location

Related Publications (12)

  • 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.

    PMID: 8890421BACKGROUND

  • 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.

    PMID: 9358090BACKGROUND

  • 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.

    PMID: 16036187BACKGROUND

  • 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.

    PMID: 7824244BACKGROUND

  • 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.

    PMID: 9154785BACKGROUND

  • 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.

    PMID: 22336819BACKGROUND

  • 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.

    PMID: 1328308BACKGROUND

  • 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.

    PMID: 15672006BACKGROUND

  • 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.

    PMID: 19573821BACKGROUND

  • 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.

    PMID: 24785858BACKGROUND

  • 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.

    PMID: 20622581BACKGROUND

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

    PMID: 17469705BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 15, 2018

Study Start

February 11, 2019

Primary Completion

July 12, 2020

Study Completion

July 27, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

IL(1)