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RecruitingNCT03326154Updated Sep 3, 2020

Post-Cholecystectomy Quality of Life

An observational study in Gallstone, sponsored by Helsinki University Central Hospital. Recruiting at 2 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Helsinki University Central Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2022, 4 years 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2017; still recruiting 9 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Gallstone

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Keywords

  • cholecystectomy
  • quality of life
03

In context

Gallstones

199 studies on the registry are indexed under Gallstones; 35 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 70 observational studies indexed under Gallstones.

Browse Gallstones studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Browse Helsinki University Central Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

1000

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • laparoscopic cholecystectomy patients
  • indication for operation symptomatic gallstones

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention, observational

    Observation

06

What researchers measure

Primary outcomes

  1. Quality of life: Gastrointestinal Quality of Life GIQLI score

    10 point improvement in Gastrointestinal Quality of Life GIQLI score

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
  • Jorvi, Helsinki University Hospital
    Espoo, Finland
    Recruiting
    • Hanna Lampela, MD, PhD · Contact
  • HUS Hyvinkää Hospital
    Hyvinkää, Finland
    Recruiting
    • Taina Nykänen, MD · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Sep 2022, 66 months after the start.

Of 23 observational studies under Gallstones, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's planned 66 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Oct 31, 2017
StartActual
Mar 1, 2017
Primary completionEst.
Sep 1, 2022
CompletionEst.
Mar 1, 2032
Last update
Sep 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03326154
Lead sponsor
Helsinki University Central Hospital
Responsible party
Hanna Lampela (Ph.D., Helsinki University Central Hospital) — Principal investigator
First posted
Oct 31, 2017
Start date
Mar 1, 2017
Primary completion
Sep 1, 2022 (estimated)
Completion
Mar 1, 2032 (estimated)
Last update
Sep 3, 2020

Study contacts

Hanna Lampela, MD, PhD
Contact
hanna.lampela@hus.fi
+358504286224
Hanna Lampela, MD, PhD
study chair · Helsinki University Central Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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