Quality of Life After Liver Resection | NCT00681499

Studies
Quality of Life After Liver Resection

NCT00681499

Sponsor

University of Bern

Status

Completed

Last Update Posted

Nov 13, 2015Estimated

Enrollment

198Actual

Phase

Not provided

Conditions

Liver Diseases
Liver Neoplasms

Interventions

Not provided

Countries

Switzerland

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

May 19, 2008

First Submission Date that Met QC Criteria

May 19, 2008

First Posted Date

May 21, 2008Estimated

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

Nov 12, 2015

Last Update Posted Date

Nov 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Patients with malignant diseases are increasingly receiving more extensive hepatic resections, with im-proved preoperative and postoperative care leading to a reduced postoperative morbidity and mortality. In this setting, postoperative quality of life may become as important as overall patient survival. In this study we will be investigating the effect of the initial disease for which hepatic resection was carried out on short- and long-term quality of life.

Detailed Description

Background: Due to advances in operative methods and perioperative care, mortality and morbidity following major hepatic resection have decreased substantially, making long-term quality of life (QoL) an increasingly prominent issue.

Objectives: We plan on evaluating whether postoperative diagnosis is associated with long-term QoL and health in patients who require hepatic surgery for benign or malignant diseases and how QoL evolves with time.

Method: QoL will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and the liver-specific QLQ-LMC21 module. All patients requiring hepatic surgery aged >18 years will be included in the study. QoL evaluation is carried out preoperatively and at set intervals postoperatively.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
malignant		eg. hepatocellular carcinoma, colorectal liver metastases
benign		eg. liver cysts, traumatic liver injuries, adenoma etc

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life		preoperatively, 1-,3-,6-,12 months postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with planned liver resection

Exclusion Criteria

Patients with biopsy of the liver only
Inability of understanding the questionnaire

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

All patients requiring liver resection for any benign or malignant liver diseases, including secondary tumours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vanessa Banz, MD	Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of visceral and transplant surgery, Bern University Hospital		Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8014530	Background	Cella DF. Quality of life: concepts and definition. J Pain Symptom Manage. 1994 Apr;9(3):186-92. doi: 10.1016/0885-3924(94)90129-5.
1392964	Background	Slevin ML. Quality of life: philosophical question or clinical reality? BMJ. 1992 Aug 22;305(6851):466-9. doi: 10.1136/bmj.305.6851.466. No abstract available.

ID	Term
D004066	Digestive System Diseases
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms