NCT01546480

Brief Summary

Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation. The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation. 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
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

2.3 years

First QC Date

March 2, 2012

Last Update Submit

June 16, 2014

Conditions

Pain

Keywords

Chronic postoperative painPostcholecystectomy painInflammationInterleukines

Outcome Measures

Primary Outcomes (1)

  • Spinal interleukine levels

    12 months after surgery

    12 months

Secondary Outcomes (3)

  • Blood interleukine levels

    12 Months

  • spinal enzyme levels

    12 months

  • Blood enzyme levels

    12 months

Study Arms (3)

Pain patients

Patients with unexplained chronic abdominal pain 12 months after elective cholecystectomy

Operated painfree Patients

Painfree patients 12 months after elective cholecystectomy

Nonoperated painfree patients

Painfree patients with no previous abdominal operation

Eligibility Criteria

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

Patients in group 1 and 2 previously participated in a study of postcholecystectomy pain. Patients in group 3 are patients scheduled for elective surgery in spinal anesthesia at the participating centres.

You may qualify if:

  • Unexplained abdominal pain 12 months after elective cholecystectomy

You may not qualify if:

  • Immunosuppressive treatment (NSAID excepted)
  • Anticoagulant treatment
  • Group 2:
  • No pain 12 months after elective cholecystectomy
  • Immunosuppressive treatment (NSAID excepted)
  • Anticoagulant treatment
  • Group 3:
  • Elective operation in spinal anesthesia or
  • Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected
  • Acute or chronic pain condition
  • Immunosuppressive treatment (NSAID excepted)
  • Previous abdominal operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Odense University Hospital

Odense, 5000, Denmark

Location

Lillebælt Hospital

Vejle, 7100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum Plasma Cerebrospinal fluid Saliva

MeSH Terms

Conditions

PainPain, PostoperativeInflammation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Afdelingslæge

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

November 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

DK(2)