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Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients

NCT ID: NCT00971750

Last Updated: 2012-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Asymptomatic cholelithiasis is a prevalent condition in obese patients presenting for bariatric surgery. Transabdominal ultrasound (TAU) remains the gold standard for detection of cholelithiasis. The sensitivity and specificity of transabdominal ultrasound for cholelithiasis reported in literature is between 88-97% and 97-99%, respectively. The ability to detect cholelithiasis with TAU in the obese population may be inhibited due to the presence of increased subcutaneous and visceral fat. Laparoscopic ultrasound (LU) has the potential to overcome these technical challenges. In an era of minimally invasive bariatric surgery, it has been suggested that routine preoperative ultrasound TAU be performed for the detection of cholelithiasis since intraoperative palpation is not feasible. We hypothesize that laparoscopic ultrasound will be more sensitive and specific for cholelithiasis than transabdominal ultrasound in morbidly obese patients.

Conditions

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Cholelithiasis Ultrasonography Laparoscopic Gastric Bypass

Keywords

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ultrasonography gallbladder cholelithiasis laparoscopic gastric bypass obesity bariatric surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Prior history of gallbladder surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gundersen Lutheran Health System

OTHER

Sponsor Role collaborator

Gundersen Lutheran Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Kara Kallies

Advanced Research Associate, under direction of Shanu N. Kothari, MD, (PI)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shanu N Kothari, MD

Role: PRINCIPAL_INVESTIGATOR

Gundersen Lutheran Health System

Locations

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Gundersen Lutheran Health System

La Crosse, Wisconsin, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 2122943 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3532178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7979854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6608231 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23571143 (View on PubMed)

Other Identifiers

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2-03-08-009

Identifier Type: -

Identifier Source: org_study_id