GallstoneNCT03326154
Post-Cholecystectomy Quality of Life
An observational study of Gallstone, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
The study aims to identify factors associated with no increase in gastrointestinal quality of life after elective cholecystectomy for gallstones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone
- How many people
- 1,000 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Mar 2017to 1 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000
Who may be able to join
- laparoscopic cholecystectomy patients
- indication for operation symptomatic gallstones
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Jorvi, Helsinki University Hospital
Espoo
Hanna Lampela, MD, PhD
- Recruiting
HUS Hyvinkää Hospital
Hyvinkää
Taina Nykänen, MD
About this study
Official title: 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.
- Conditions
- Gallstone
- Being tested
- No intervention, observational
- Keywords
- cholecystectomy, quality of life
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observationalOther
Observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life: Gastrointestinal Quality of Life GIQLI score
10 point improvement in Gastrointestinal Quality of Life GIQLI score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Mar 2017
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Lampela, Helsinki University Central Hospital
- Investigators
- Hanna Lampela, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326154
- Sponsor's protocol ID
- HUS/2317/2016
- Status last verified
- Sep 2020
- First submitted
- 26 Oct 2017
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life and Abdominal Symptoms After Cholecystectomy
- ClinicalTrials.gov ID
- NCT03326154
- Acronym / sponsor ID
- HUS/2317/2016
- Conditions
- Gallstone
- Keywords
- cholecystectomy, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to identify factors associated with no increase in gastrointestinal quality of life after elective cholecystectomy for gallstones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000
Key inclusion criteria (2 listed)
- laparoscopic cholecystectomy patients
- indication for operation symptomatic gallstones
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observationalObservation | Other | – |
Primary outcome
Quality of life: Gastrointestinal Quality of Life GIQLI score
Time frame: 1 year
10 point improvement in Gastrointestinal Quality of Life GIQLI score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
Related trials for Gallstone
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Lampela, MD, PhD study chair
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone, run by Helsinki University Central Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Lampela, MD, PhD (+358504286224, hanna.lampela@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life: Gastrointestinal Quality of Life GIQLI score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.