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Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy. (life-in)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01289093
Recruitment Status : Completed
First Posted : February 3, 2011
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Inguinal Hernia Incisional Hernia Umbilical Hernias

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.

Study Design

Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life After Laparoscopic Inguinal- Incisional- and Umbilical Herniotomy.
Study Start Date : March 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

laparoscopic ingunal herniotomy
laparoscopic incisional herniotomy
Lichtenstein inguinal herniotomy
laparoscopic umbilical hernia repair

Outcome Measures

Primary Outcome Measures :
  1. quality of life [ Time Frame: before operation until 90 days postoperative ]
    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.

Secondary Outcome Measures :
  1. acceptability [ Time Frame: preoperative untill 90 days postoperative ]
    The investigators measure the patients satisfaction with the instruments and which one (VAS or CCS) they prefer.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289093

Koege University Hospital
Koege, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Study Director: Thue Bisgaard, MD Zealand University Hospital
More Information

Responsible Party: Mette M W Christoffersen, MD, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT01289093     History of Changes
Other Study ID Numbers: 1234
First Posted: February 3, 2011    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Mette M W Christoffersen, Zealand University Hospital:
inguinal hernia
incisional hernia
quality of life

Additional relevant MeSH terms:
Hernia, Inguinal
Incisional Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Infant, Newborn, Diseases
Hernia, Ventral