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Completed

NCT Number: NCT01289093

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

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.

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Key information

Conditions

Inguinal Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Umbilical Hernia, Ventral Incisional Hernia Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Umbilical Hernias

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Koege University Hospital

Koege, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Bispebjerg Hospital
  • University Hospital, Gentofte, Copenhagen

Registry information

Official study title

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

Acronym: life-in

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2011
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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