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

NCT01289093 | Completed DMC

• 1 other identifier: 1234
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Incisional Hernia; Umbilical Hernias

Keywords

inguinal hernia; incisional hernia; quality of life; disease-specific

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• acceptability

  preoperative untill 90 days postoperative

Study Arms (4)

laparoscopic ingunal herniotomy

laparoscopic incisional herniotomy

Lichtenstein inguinal herniotomy

laparoscopic umbilical hernia repair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care

You may qualify if:

• 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

You may not qualify if:

• expected bad compliance to the study
• acute operations
• re-operations
• secondary operations
• primary operation with reoperation within 30 days

Sponsors & Collaborators

• Zealand University Hospital: lead
• Bispebjerg Hospital: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Koege University Hospital

Koege, 4600, Denmark

Location

MeSH Terms

Conditions

Hernia, Inguinal; Incisional Hernia; Hernia, Umbilical

Condition Hierarchy (Ancestors)

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

Study Officials

• Thue Bisgaard, MD

  Zealand University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 3, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

DK (1)