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Post-Cholecystectomy Quality of Life

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ClinicalTrials.gov Identifier: NCT03326154
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hanna Lampela, Helsinki University Central Hospital

Brief Summary:
The study aims to identify factors associated with no increase in gastrointestinal quality of life after elective cholecystectomy for gallstones.

Condition or disease Intervention/treatment
Gallstone Other: No intervention, observational

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Related Quality of Life and Abdominal Symptoms After Cholecystectomy
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones


Intervention Details:
  • Other: No intervention, observational
    Observation


Primary Outcome Measures :
  1. Quality of life: Gastrointestinal Quality of Life GIQLI score [ Time Frame: 1 year ]
    10 point improvement in Gastrointestinal Quality of Life GIQLI score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1000
Criteria

Inclusion Criteria:

  • laparoscopic cholecystectomy patients
  • indication for operation symptomatic gallstones

Exclusion Criteria:

  • previous complication of gallstone disease
  • indication for cholecystectomy other than symptomatic gallstones
  • illness significantly lowering quality of life
  • inability to fill in questionnaires
  • denies participation

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): NCT03326154


Contacts
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Contact: Hanna Lampela, MD, PhD +358504286224 hanna.lampela@hus.fi

Locations
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Finland
Jorvi, Helsinki University Hospital Recruiting
Espoo, Finland
Contact: Hanna Lampela, MD, PhD         
HUS Hyvinkää Hospital Recruiting
Hyvinkää, Finland
Contact: Taina Nykänen, MD         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Chair: Hanna Lampela, MD, PhD Helsinki University Central Hospital

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Responsible Party: Hanna Lampela, Ph.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03326154     History of Changes
Other Study ID Numbers: HUS/2317/2016
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanna Lampela, Helsinki University Central Hospital:
cholecystectomy
quality of life

Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical