Clinical trial NCT02320071: Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair
Official title: Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hernia, Ventral
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2014-12-19
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective study includes 25 patients undergoing elective laparoscopic incisional hernia repair. Patients are included from Bispebjerg Hospital and Hvidovre Hospital, two university hospital surgical departments with unrestricted referral of patients.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Abdominal wall strength
timeFrame: Change at three months from baseline examination
measure: Hernia-related quality of life
timeFrame: Change at three months from baseline examination
Secondary outcomes:
measure: Physical activity level
timeFrame: Change at three months from baseline examination
measure: Pain
timeFrame: Change at three months from baseline examination
measure: Discomfort
timeFrame: Change at three months from baseline examination
measure: Forced vital capacity
timeFrame: Change at three months from baseline examination
measure: Forced expiratorry volume for one second (FEV1)
timeFrame: Change at three months from baseline examination
measure: Maximal inspiratory pressure
timeFrame: Change at three months from baseline examination
measure: Maximal expiratory pressure
timeFrame: Change at three months from baseline examination
Other outcomes:
Locations:
city: Copenhagen NW
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: Gastrounit, Surgical Section, Hvidovre Hospital
name: Thue Bisgaard, MD, Dr. Msc.
role: STUDY_CHAIR
References: