NCT00971750

Brief Summary

The objective of this study is to prospectively compare laparoscopic ultrasound to transabdominal ultrasound for the detection of gallbladder pathology in obese patients presenting for laparoscopic gastric bypass. We hypothesize that laparoscopic ultrasound will be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 1, 2003

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 2, 2012

Completed
Last Updated

July 11, 2012

Status Verified

June 1, 2012

Enrollment Period

7 years

First QC Date

September 3, 2009

Results QC Date

March 23, 2012

Last Update Submit

June 29, 2012

Conditions

CholelithiasisUltrasonographyLaparoscopic Gastric Bypass

Keywords

ultrasonographygallbladdercholelithiasislaparoscopicgastric bypassobesitybariatric surgery

Outcome Measures

Primary Outcomes (2)

  • Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.

    Number of patients with cholelithiasis.

    transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively

  • Polyps on Transabdominal and Laparoscopic Ultrasound

    Number of patients with polyps.

    6 years

Secondary Outcomes (1)

  • Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.

    transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively

Study Arms (1)

Ultrasound Study Group

Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will consist of patients undergoing laparoscopic gastric bypass at a community-based teaching institution.

You may qualify if:

  • Morbidly obese patients undergoing elective laparoscopic roux-en-Y gastric bypass

You may not qualify if:

  • Prior history of gallbladder surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gundersen Lutheran Health System

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (5)

  • Yang HL, Li ZZ, Sun YG. Reliability of ultrasonography in diagnosis of biliary lithiasis. Chin Med J (Engl). 1990 Aug;103(8):638-41.

    PMID: 2122943BACKGROUND

  • Cronan JJ. US diagnosis of choledocholithiasis: a reappraisal. Radiology. 1986 Oct;161(1):133-4. doi: 10.1148/radiology.161.1.3532178.

    PMID: 3532178BACKGROUND

  • Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22):2573-81.

    PMID: 7979854BACKGROUND

  • Einstein DM, Lapin SA, Ralls PW, Halls JM. The insensitivity of sonography in the detection of choledocholithiasis. AJR Am J Roentgenol. 1984 Apr;142(4):725-8. doi: 10.2214/ajr.142.4.725.

    PMID: 6608231BACKGROUND

  • Kothari SN, Obinwanne KM, Baker MT, Mathiason MA, Kallies KJ. A prospective, blinded comparison of laparoscopic ultrasound with transabdominal ultrasound for the detection of gallbladder pathology in morbidly obese patients. J Am Coll Surg. 2013 Jun;216(6):1057-62. doi: 10.1016/j.jamcollsurg.2013.02.009. Epub 2013 Apr 6.

    PMID: 23571143DERIVED

MeSH Terms

Conditions

CholelithiasisObesity

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Shanu Kothari
Organization
Gundersen Lutheran Health System
snkothar@gundluth.org
608-775-2331

Study Officials

  • Shanu N Kothari, MD

    Gundersen Lutheran Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advanced Research Associate, under direction of Shanu N. Kothari, MD, (PI)

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

October 1, 2003

Primary Completion

October 1, 2010

Study Completion

October 1, 2011

Last Updated

July 11, 2012

Results First Posted

July 2, 2012

Record last verified: 2012-06

Locations

US(1)