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

Completed

• Conditions: Umbilical Hernias; Incisional Hernia; Inguinal Hernia

• Registration Number: NCT01289093
• Lead Sponsor: Zealand University Hospital

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.

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 Timeline

• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Study Start: 2011-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of life	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

Name	Time	Method
acceptability	preoperative untill 90 days postoperative	The investigators measure the patients satisfaction with the instruments and which one (VAS or CCS) they prefer.

Trial Locations

Locations (1)

Koege University Hospital; 🇩🇰 Koege, Denmark