NCT03326154

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
71mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress61%
Mar 2017Mar 2032

Study Start

First participant enrolled

March 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Expected
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

5.5 years

First QC Date

October 26, 2017

Last Update Submit

September 2, 2020

Conditions

Gallstone

Keywords

cholecystectomyquality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life: Gastrointestinal Quality of Life GIQLI score

    10 point improvement in Gastrointestinal Quality of Life GIQLI score

    1 year

Interventions

No intervention, observationalOTHER

Observation

Eligibility Criteria

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

1000

You may qualify if:

  • laparoscopic cholecystectomy patients
  • indication for operation symptomatic gallstones

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jorvi, Helsinki University Hospital

Espoo, Finland

RECRUITING

HUS Hyvinkää Hospital

Hyvinkää, Finland

RECRUITING

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hanna Lampela, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

Central Study Contacts

Hanna Lampela, MD, PhD

CONTACT

+358504286224hanna.lampela@hus.fi

Study Design

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

Study Record Dates

First Submitted

October 26, 2017

First Posted

October 31, 2017

Study Start

March 1, 2017

Primary Completion

September 1, 2022

Study Completion (Estimated)

March 1, 2032

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

FI(2)