Quality of Life After Laparoscopic Inguinal- Incisional a... | NCT01289093

Studies
Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy.

NCT01289093

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

140Actual

Phase

Not provided

Conditions

Inguinal Hernia
Incisional Hernia
Umbilical Hernias

Interventions

Not provided

Countries

Denmark

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

Jan 2017

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

Mar 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Feb 2, 2011

First Submission Date that Met QC Criteria

Feb 2, 2011

First Posted Date

Feb 3, 2011Estimated

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

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mette M W Christoffersen, MD, Zealand University HospitalPrincipal Investigator

Lead Sponsor

Zealand University HospitalOTHER

Collaborators

Name	Class
Bispebjerg Hospital	OTHER
University Hospital, Gentofte, Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a disease-specific quality of life questionnaire, designed by an American group, to monitor quality of life in patients undergoing operation for hernias.

The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality of life and other well-known core-symptoms before and after herniotomies.

Detailed Description

The investigators include consecutively all in all 140 patients. 100 with inguinal hernias; 50 who is getting a Lichtenstein operation and 50 who is getting a laparoscopic operation. Furthermore minimum 20 patients who is getting a laparoscopic operation for incisional hernia and minimum 20 who went through umbilical herniotomy. The investigators monitor their pain, sensation of mesh, movement limitations, over-all well-being, fatigue and life-quality, with both CCS and VAS questionnaires 5 times. One time preoperative and 4 times after operation, on the 1sth, 7th, 30th and 90th day after operation.

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

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic ingunal herniotomy
laparoscopic incisional herniotomy
Lichtenstein inguinal herniotomy
laparoscopic umbilical hernia repair

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of life	pain, sensation of mesh, movement limitations, over-all well-being, fatigue and quality of life. These core symptoms will be measured 5 times with the 2 questionnaires CCS and VAS. One time before and 4 times after the operation with both the CCS and VAS, to see if the is a graphical correlation between the to questionnaires and to find out which of the two questionnaires is best.	before operation until 90 days postoperative

Secondary Outcomes

Measure	Description	Time Frame
acceptability	The investigators measure the patients satisfaction with the instruments and which one (VAS or CCS) they prefer.	preoperative untill 90 days postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective laparoscopic and open operations for inguinal hernia
elective laparoscopic operation for incisional- and umbilical hernia
primary hernia
uni-bilateral hernias and one or more incisional hernias

Exclusion Criteria:

expected bad compliance to the study
acute operations
re-operations
secondary operations
primary operation with reoperation within 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thue Bisgaard, MD	Zealand University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Koege University Hospital		Koege		4600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D000069290	Incisional Hernia
D006554	Hernia, Umbilical

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided