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Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575276
First Posted: December 18, 2007
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
  Purpose
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.

Condition
Cholecystitis, Acute Cholecystitis, Chronic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Sex-Dependent Modulation of Clinical Outcomes Following Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio:

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.

Enrollment: 102
Study Start Date: August 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Females with acute cholecystitis
2
Females with Chronic Cholecystitis
3
Males with acute cholecystitis
4
Males with Chronic Cholecystitis

Detailed Description:

A patient's gender is a strong and significant predictor for substantial differences in clinical outcomes such as postoperative pain, analgesic use, and surgical complications (gangrenous gallbladder, empyema of the gallbladder, gallbladder perforation, and conversion to open surgery) following laparoscopic cholecystectomy (Bingener et al., 2002; Bingener et al., 2003; Uchiyama et al., 2006). Although females present for laparoscopic cholecystectomy more frequently (76% of the cases); the prevalence of surgical complications during cholecystectomy is higher in men, most frequently because of inflammation or deterioration of the gallbladder (Bingener et al., 2002; Bingener et al., 2003; Stefanidis et al., 2006). Post-operatively, however, females report significantly greater pain scores and require larger amounts of analgesics (Uchiyama et al., 2006), suggesting that although surgeries are completed with fewer problems, females still report more post-operative pain. Sex-related differences in pain thresholds and tolerance to thermal, pressure, and electrical stimuli in experimental pain models indicate that pain differences are not solely due to psychosocial distinctions between the sexes (Riley et al., 1998).

There are multiple physiological differences between males and females; however, considerable evidence implicates estrogenic sex hormones as critical factors in sex-dependent differences in pain (see review by Fillingim and Ness, 2000). It is possible that estrogens alter inflammatory mediator profiles in the gallbladder, which subsequently increase sensitization of visceral neurons innervating the gallbladder, resulting in increased pain in females. The first portion of this study will extend the association of patient sex with clinical outcomes to determine whether circulating and/or local estrogen levels correlate with differences in peri-operative morbidity, including intra-operative complications, conversion to open cholecystectomy, postoperative pain, inadequate wound healing, intra-abdominal infection, disability and mortality.

Previous studies have demonstrated that the cytokines TNFalpha and IL-1beta alter the sensitivity of sensory neurons and increase nociception (Opree and Kress, 2000). To determine whether estrogen levels alter the profile of inflammatory mediators within the gallbladder and result in an increase in nociceptive thresholds in females, we will correlate circulating and/or local levels of estrogens with the amount of inflammatory mediators present within laparoscopically excised gallbladder biopsies. Patients who meet the inclusion criteria will be recruited from University Hospital in San Antonio. Inflammatory mediators, including the cytokines IL-1beta, TNFalpha, IL-8, IL-6, IL-10, and IL-12p70 will be assayed from interstitial fluid of biopsies from the fundus and infundibulum of the gallbladder. Biopsies will be classified according to clinical assessment prior to surgery to control for expected differences in inflammatory mediators in acute versus chronic cholecystitis.

The immediate effects of this research will be to clearly delineate whether estrogens are predictive of improved clinical outcomes following surgery and to determine whether these sex hormones correlate with altered production of inflammatory mediators in the gallbladder.

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient General Surgery patients indicated for Laparoscopic Cholecystectomy
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575276


Locations
United States, Texas
University Hospital System
San Antonio, Texas, United States, 78228
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: 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
  More Information

Responsible Party: Kenneth Hargreaves, Chair Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00575276     History of Changes
Other Study ID Numbers: HSC20070426
First Submitted: December 15, 2007
First Posted: December 18, 2007
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio:
Pain, Cholecystectomy, Cytokines, Sex Differences

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases