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

This study has been completed.
Sponsor:
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Mette M W Christoffersen, Koege Sygehus
ClinicalTrials.gov Identifier:
NCT01289093
First received: February 2, 2011
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Inguinal Hernia
Incisional Hernia
Umbilical Hernias

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life After Laparoscopic Inguinal- Incisional- and Umbilical Herniotomy.

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Koege Sygehus:

Primary Outcome Measures:
  • quality of life [ Time Frame: before operation until 90 days postoperative ] [ Designated as safety issue: No ]
    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:
  • acceptability [ Time Frame: preoperative untill 90 days postoperative ] [ Designated as safety issue: No ]
    The investigators measure the patients satisfaction with the instruments and which one (VAS or CCS) they prefer.


Enrollment: 140
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
laparoscopic ingunal herniotomy
laparoscopic incisional herniotomy
Lichtenstein inguinal herniotomy
laparoscopic umbilical hernia repair

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289093

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

No publications provided

Responsible Party: Mette M W Christoffersen, MD, Koege Sygehus
ClinicalTrials.gov Identifier: NCT01289093     History of Changes
Other Study ID Numbers: 1234
Study First Received: February 2, 2011
Last Updated: May 25, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Koege Sygehus:
inguinal hernia
incisional hernia
quality of life
disease-specific

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Umbilical
Pathological Conditions, Anatomical
 Hernia, Abdominal
Infant, Newborn, Diseases
Hernia, Ventral

ClinicalTrials.gov processed this record on May 19, 2013