Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair

Hernia, Ventral Clinical Trial

— QualiFunc  

Official title:

Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02320071
• Other study ID #: H-1-2014-118
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2014
• Last updated: September 2, 2015
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: Bispebjerg Hospital
• Contact: Kristian Kiim Jensen, MD
• Phone: +4535312201
• Email: kristian.kiim.jensen[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The primary objective of the present study is to investigate a possible correlation between abdominal wall function and subjective measures of QoL before and after laparoscopic repair of small- to medium sized incisional hernia.

This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair. Abdominal wall function is examined by determination of maximal truncal flexion and extension with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland). Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity (International Physical Activity Questionnaire) are assessed. Patients are examined before, one month after and three months after the operation. Furthermore, pulmonary function is examined preoperative and three months postoperative by standard spirometry (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in- and expiratory pressure is measured.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Elective laparoscopic repair for one or more incisional hernias in the midline (at least 5 cm caudal to the xiphoid process and at least 5 cm cranial to the pubic bone), using a synthetic mesh

• Horizontal fascial defect between 3 and 8 cm

• Age between 25 and 75 years

• American Association of Anesthesiologist score between I and III

• Body mass index < 33 kg/m^2

Exclusion Criteria:

• Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries

• Existing stoma

• Postoperative complications requiring intervention

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

Other:
• Examination of abdominal wall strength changes over time

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NW	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal wall strength	Abdominal wall strength measured by Goodstrength Dynamometer before, one and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination	No
Primary	Hernia-related quality of life	Hernia-related quality of life (HerQLes) before, one and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination	No
Secondary	Physical activity level	International Physical Activity Questionnaire (IPAQ) score before and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination	No
Secondary	Pain	Pain on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination	No
Secondary	Discomfort	Discomfort on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.	Change at three months from baseline examination	No
Secondary	Forced vital capacity	Forced vital capacity measured by spirometry	Change at three months from baseline examination	No
Secondary	Forced expiratorry volume for one second (FEV1)	Forced expiratorry volume for one second measured by spirometry	Change at three months from baseline examination	No
Secondary	Maximal inspiratory pressure	Maximal inspiratory pressure measured by pressure monitor	Change at three months from baseline examination	No
Secondary	Maximal expiratory pressure	Maximal inspiratory pressure measured by pressure monitor	Change at three months from baseline examination	No