Post-Cholecystectomy Quality of Life | NCT03326154

Studies
Post-Cholecystectomy Quality of Life

NCT03326154

Sponsor

Helsinki University Central Hospital

Status

Recruiting

Last Update Posted

Sep 3, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Gallstone

Interventions

No intervention, observational

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Mar 1, 2032Estimated

First Submitted Date

Oct 26, 2017

First Submission Date that Met QC Criteria

Oct 26, 2017

First Posted Date

Oct 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2020

Last Update Posted Date

Sep 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention, observational	Other	Observation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

1000

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hanna Lampela, MD, PhD	Contact	+358504286224		hanna.lampela@hus.fi

Overall Officials

Name	Affiliation	Role
Hanna Lampela, MD, PhD	Helsinki University Central Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jorvi, Helsinki University Hospital	Recruiting	Espoo			Finland

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

Browse Leaves

Not provided

Browse Branches

Not provided