Hernia, VentralQualiFuncNCT02320071
Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair
An observational study of Hernia, Ventral, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Examination of abdominal wall strength changes over time
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries
- Existing stoma
- Postoperative complications requiring intervention
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen Northwest, Copenhagen, 2400
Kristian Kiim Jensen, MD, kristian.kiim.jensen@regionh.dk
Kristian Kiim Jensen, MD
About this study
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.
- Conditions
- Hernia, Ventral
- Being tested
- Examination of abdominal wall strength changes over time
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of abdominal wall strength changes over timeOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Examination of abdominal wall strength changes over time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall strength
Abdominal wall strength measured by Goodstrength Dynamometer before, one and three months after laparoscopic incisional hernia repair.
Measured: 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.
Measured: Change at three months from baseline examination
Secondary outcomes (7)
Physical activity level
International Physical Activity Questionnaire (IPAQ) score before and three months after laparoscopic incisional hernia repair.
Measured: Change at three months from baseline examination
Pain
Pain on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.
Measured: Change at three months from baseline examination
Discomfort
Discomfort on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.
Measured: Change at three months from baseline examination
Forced vital capacity
Forced vital capacity measured by spirometry
Measured: Change at three months from baseline examination
Forced expiratorry volume for one second (FEV1)
Forced expiratorry volume for one second measured by spirometry
Measured: Change at three months from baseline examination
Maximal inspiratory pressure
Maximal inspiratory pressure measured by pressure monitor
Measured: Change at three months from baseline examination
Maximal expiratory pressure
Maximal inspiratory pressure measured by pressure monitor
Measured: Change at three months from baseline examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Kristian Kiim Jensen, Bispebjerg Hospital
- Investigators
- Thue Bisgaard, MD, Dr. Msc., Study chair, Gastrounit, Surgical Section, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320071
- Sponsor's protocol ID
- H-1-2014-118
- Acronym
- QualiFunc
- Status last verified
- Sep 2015
- First submitted
- 16 Dec 2014
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair
- ClinicalTrials.gov ID
- NCT02320071
- Acronym / sponsor ID
- QualiFunc / H-1-2014-118
- Conditions
- Hernia, Ventral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with incisional hernia | – | Other: Examination of abdominal wall strength changes over timePatients 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries
- Existing stoma
- Postoperative complications requiring intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination of abdominal wall strength changes over time | Other | Patients with incisional hernia |
Primary outcome
Abdominal wall strength
Time frame: 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
Time frame: Change at three months from baseline examination
Hernia-related quality of life (HerQLes) before, one and three months after laparoscopic incisional hernia repair.
7 secondary outcomes
Physical activity level
Time frame: Change at three months from baseline examination
Pain
Time frame: Change at three months from baseline examination
Discomfort
Time frame: Change at three months from baseline examination
Forced vital capacity
Time frame: Change at three months from baseline examination
Forced expiratorry volume for one second (FEV1)
Time frame: Change at three months from baseline examination
Maximal inspiratory pressure
Time frame: Change at three months from baseline examination
Maximal expiratory pressure
Time frame: Change at three months from baseline examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thue Bisgaard, MD, Dr. Msc. study chair
Gastrounit, Surgical Section, Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Ventral, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristian Kiim Jensen, MD (+4535312201, kristian.kiim.jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal wall strength (time frame: Change at three months from baseline examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2015.