Cholecystitis, AcuteNCT00575276
Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy
An observational study of Cholecystitis, Acute and Cholecystitis, Chronic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis, Acute, Cholecystitis, Chronic
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient General Surgery patients indicated for Laparoscopic Cholecystectomy
Who may be able to join
- Males or Non-pregnant females
- Between ages 18-90
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital System
San Antonio, Texas, 78228
About this study
Official title: Sex-Dependent Modulation of Clinical Outcomes Following Laparoscopic Cholecystectomy
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.
Read the 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.
- Conditions
- Cholecystitis, Acute, Cholecystitis, Chronic
- Keywords
- Pain, Cholecystectomy, Cytokines, Sex Differences
- Medical subject headings
- Cholecystitis, Acute, Cholecystitis, Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Females with acute cholecystitis | |
| 2 | Females with Chronic Cholecystitis | |
| 3 | Males with acute cholecystitis | |
| 4 | Males with Chronic Cholecystitis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startAug 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
- Investigators
- Kenneth M Hargreaves, DDS, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioJuliana Bingener-Casey, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575276
- Sponsor's protocol ID
- HSC20070426
- Status last verified
- Mar 2012
- First submitted
- 15 Dec 2007
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-Dependent Modulation of Clinical Outcomes Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT00575276
- Acronym / sponsor ID
- HSC20070426
- Conditions
- Cholecystitis, Acute, Cholecystitis, Chronic
- Keywords
- Pain, Cholecystectomy, Cytokines, Sex Differences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Females with acute cholecystitis |
| 2 | – | –Females with Chronic Cholecystitis |
| 3 | – | –Males with acute cholecystitis |
| 4 | – | –Males with Chronic Cholecystitis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient General Surgery patients indicated for Laparoscopic Cholecystectomy
Key inclusion criteria (2 listed)
- Males or Non-pregnant females
- Between ages 18-90
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Hargreaves, DDS, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Juliana Bingener-Casey, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Acute and Cholecystitis, Chronic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.