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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hernia, Ventral

Intervention / Treatment
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* Other: Examination of abdominal wall strength changes over time


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with incisional hernia<br>Patients with one or more incisional hernias, combined horizontal fascial defect 3-8 cm, planned for laparoscopic mesh repair. Patients are examined before and one and three months postoperative in regard to abdominal wall function, pain, discomfort, hernia-related quality of life and physical activity level. | Other: Examination of abdominal wall strength changes over time<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain | Pain on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair. | Change at three months from baseline examination | 
| Discomfort | Discomfort on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair. | Change at three months from baseline examination | 
| Forced vital capacity | Forced vital capacity measured by spirometry | Change at three months from baseline examination | 
| Forced expiratorry volume for one second (FEV1) | Forced expiratorry volume for one second measured by spirometry | Change at three months from baseline examination | 
| Maximal inspiratory pressure | Maximal inspiratory pressure measured by pressure monitor | Change at three months from baseline examination | 
| Maximal expiratory pressure | Maximal inspiratory pressure measured by pressure monitor | Change at three months from baseline examination |