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

Inguinal Hernia Clinical Trial

— life-in  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289093
• Other study ID #: 1234
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: January 30, 2017
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2017
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Umbilical
• Incisional Hernia
• Inguinal Hernia
• Umbilical Hernias

Locations

Country	Name	City	State
Denmark	Koege University Hospital	Koege

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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