Hernia, Ventral
Conditions
Brief 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.
Interventions
OTHERExamination of abdominal wall strength changes over time
Sponsors
Hvidovre University Hospital
Bispebjerg Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal wall strength | Change at three months from baseline examination | Abdominal wall strength measured by Goodstrength Dynamometer before, one and three months after laparoscopic incisional hernia repair. |
| Hernia-related quality of life | Change at three months from baseline examination | Hernia-related quality of life (HerQLes) before, one and three months after laparoscopic incisional hernia repair. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort | Change at three months from baseline examination | Discomfort on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair. |
| Forced vital capacity | Change at three months from baseline examination | Forced vital capacity measured by spirometry |
| Physical activity level | Change at three months from baseline examination | International Physical Activity Questionnaire (IPAQ) score before and three months after laparoscopic incisional hernia repair. |
| Maximal inspiratory pressure | Change at three months from baseline examination | Maximal inspiratory pressure measured by pressure monitor |
| Maximal expiratory pressure | Change at three months from baseline examination | Maximal inspiratory pressure measured by pressure monitor |
| Forced expiratorry volume for one second (FEV1) | Change at three months from baseline examination | Forced expiratorry volume for one second measured by spirometry |
| Pain | Change at three months from baseline examination | Pain on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair. |
Countries
Denmark
Contacts
Primary ContactKristian Kiim Jensen, MD
Outcome results
None listed