Post-Cholecystectomy Quality of Life

September 2, 2020 updated by: Hanna Lampela, Helsinki University Central Hospital

Health Related Quality of Life and Abdominal Symptoms After Cholecystectomy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Espoo, Finland
        • Recruiting
        • Jorvi, Helsinki University Hospital
        • Contact:
          • Hanna Lampela, MD, PhD
      • Hyvinkää, Finland
        • Recruiting
        • HUS Hyvinkää Hospital
        • Contact:
          • Taina Nykänen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1000

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life: Gastrointestinal Quality of Life GIQLI score
Time Frame: 1 year
10 point improvement in Gastrointestinal Quality of Life GIQLI score
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Chair: Hanna Lampela, MD, PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

March 1, 2032

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/2317/2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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