Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy. (life-in)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Quality of Life After Laparoscopic Inguinal- Incisional- and Umbilical Herniotomy.|
- 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.
- 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.
|Study Start Date:||March 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|laparoscopic ingunal herniotomy|
|laparoscopic incisional herniotomy|
|Lichtenstein inguinal herniotomy|
|laparoscopic umbilical hernia repair|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289093
|Koege University Hospital|
|Koege, Denmark, 4600|
|Study Director:||Thue Bisgaard, MD||Koege Sygehus|