Understanding quality of life after gallbladder removal
Health Related Quality of Life and Abdominal Symptoms After Cholecystectomy
This study looks at why some people don’t feel better after having their gallbladder removed and what factors might be affecting their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 2 sites (Espoo and 1 other locations) |
| Trial ID | NCT03326154 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the factors that contribute to a lack of improvement in gastrointestinal quality of life following elective laparoscopic cholecystectomy in patients with symptomatic gallstones. By analyzing patient-reported outcomes and various demographic and clinical factors, the study aims to identify why some patients do not experience the expected benefits after surgery. The research will involve collecting data through questionnaires from eligible participants who have undergone the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have undergone laparoscopic cholecystectomy for symptomatic gallstones.
Not a fit: Patients with previous complications from gallstone disease or those undergoing cholecystectomy for non-symptomatic reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk of poor quality of life outcomes after gallbladder surgery, leading to improved preoperative counseling and management.
How similar studies have performed: While there have been studies on quality of life post-cholecystectomy, this specific observational approach focusing on factors affecting quality of life outcomes is less common, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Espoo and 1 other locations
- Jorvi, Helsinki University Hospital — Espoo, Finland (Recruiting)
- HUS Hyvinkää Hospital — Hyvinkää, Finland (Recruiting)
Study contacts
- Study coordinator: Hanna Lampela, MD, PhD
- Email: hanna.lampela@hus.fi
- Phone: +358504286224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.