Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy

NCT00575276 | Completed

• 1 other identifier: HSC20070426
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at the differences in inflammatory mediators in gallbladder tissue between males and females and the possibility that these differences contribute to a higher perception of post-operative pain in females following laparoscopic cholecystectomy.

Conditions

Cholecystitis, Acute; Cholecystitis, Chronic

Keywords

Pain, Cholecystectomy, Cytokines, Sex Differences

Study Arms (4)

1

Females with acute cholecystitis

2

Females with Chronic Cholecystitis

3

Males with acute cholecystitis

4

Males with Chronic Cholecystitis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient General Surgery patients indicated for Laparoscopic Cholecystectomy

You may qualify if:

• Males or Non-pregnant females
• Between ages 18-90

You may not qualify if:

• Pregnant Females within six months of surgery
• Individuals below age 18 or above age 90
• Previous topical or systemic corticosteroid use within three months of surgery date
• sign and symptoms of neuropathy or self-reported history of diseases or treatments known to be associeated with neuropathy
• signs and symptoms of altered immune system or self-reported diseases or treatments known to be associated with altered immune function

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Hospital System

San Antonio, Texas, 78228, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1 cm biopsies of the body and fundus of the excised gallbladder. Two 4ml blood samples collected for DNA analysis with future studies.

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis; Bronchiolitis Obliterans Syndrome; Pain

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth M Hargreaves, DDS, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

• Juliana Bingener-Casey, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Dept. of Endodontics

Study Record Dates

• First Submitted: December 15, 2007
• First Posted: December 18, 2007
• Study Start: August 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

US (1)