Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair
NCT ID: NCT02320071
Last Updated: 2015-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2015-01-31
2016-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with incisional hernia
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.
Examination of abdominal wall strength changes over time
Interventions
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Examination of abdominal wall strength changes over time
Eligibility Criteria
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Inclusion Criteria
* 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
* Existing stoma
* Postoperative complications requiring intervention
25 Years
75 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Kristian Kiim Jensen
MD, PHD student
Principal Investigators
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Thue Bisgaard, MD, Dr. Msc.
Role: STUDY_CHAIR
Gastrounit, Surgical Section, Hvidovre Hospital
Locations
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Bispebjerg Hospital
Copenhagen Northwest, Copenhagen, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-1-2014-118
Identifier Type: -
Identifier Source: org_study_id
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