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NCT03326154 Clinical Trial

Post-Cholecystectomy Quality of Life

Gallstone Clinical Trial

Official title:
Health Related Quality of Life and Abdominal Symptoms After Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03326154
Other study ID # HUS/2317/2016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date March 1, 2032

Study information
Verified date September 2020
Source Helsinki University Central Hospital
Contact Hanna Lampela, MD, PhD
Phone +358504286224
Email hanna.lampela@hus.fi
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date March 1, 2032
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention, observational
Observation

Locations
Country Name City State
Finland Jorvi, Helsinki University Hospital Espoo
Finland HUS Hyvinkää Hospital Hyvinkää

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life: Gastrointestinal Quality of Life GIQLI score 10 point improvement in Gastrointestinal Quality of Life GIQLI score 1 year
See also
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