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

NCT ID: NCT01289093

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia Incisional Hernia Umbilical Hernias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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laparoscopic ingunal herniotomy

No interventions assigned to this group

laparoscopic incisional herniotomy

No interventions assigned to this group

Lichtenstein inguinal herniotomy

No interventions assigned to this group

laparoscopic umbilical hernia repair

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mette M W Christoffersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thue Bisgaard, MD

Role: STUDY_DIRECTOR

Zealand University Hospital

Locations

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Koege University Hospital

Koege, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1234

Identifier Type: -

Identifier Source: org_study_id

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