NCT01553253

Brief Summary

Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been systematically described in terms of type of pain or sensory abnormalities etc. (allodynia, hyperalgesia etc.). The purpose of the study is to examine whether intensity of components of acute pain is predictive for development of chronic pain after cholecystectomy and to characterize the chronic pain by quantitative sensory testing. DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

2.2 years

First QC Date

March 2, 2012

Last Update Submit

June 16, 2014

Conditions

Pain

Keywords

Postcholecystectomy PainChronic Postoperative PainVisceral PainReferred painSomatic painQuantitative Sensory Testing

Outcome Measures

Primary Outcomes (1)

  • Abdominal pain

    12 months

Secondary Outcomes (3)

  • Quantitative sensory testing values in referred pain area.

    12 Months

  • Abdominal pain

    6 months

  • Quantitative sensory testing values in referred pain area.

    6 Months

Eligibility Criteria

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

Consecutive Patients for elective cholecystectomy

You may qualify if:

  • Patients for elective cholecystectomy
  • years or older at the day of the operation
  • Capable of speaking, reading and writing danish

You may not qualify if:

  • Previous abdominal operation
  • Patients with preoperative neuropathies
  • Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Odense University Hospital

Nyborg, 5800, Denmark

Location

Lillebælt Hospital

Vejle, 7100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

PainPain, PostoperativeVisceral PainPain, ReferredNociceptive Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Afdelingslæge, Ph.D.-student

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 14, 2012

Study Start

April 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

DK(2)