Incisional HerniaGIVINANCT02011048
Giant Ventral Incisional Hernia: Abdominal Wall Function, Respiratory Performance and Quality of Life
An observational study of Incisional Hernia, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
One of five patients undergoing open abdominal surgery develops an abdominal wall defect (incisional hernia) as a late complication. A fraction of these are "giant" hernia with a fascial defect beyond 10 cm. These patients are physically severely impaired, and surgical treatment is complex. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Endoscopic components separation
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Mar 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 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to the outpatient clinic at Digestive Disease Center, Bispebjerg Hospital.
Who may be able to join
- Giant ventral incisional hernia with fascial defect > 10 cm
- Scheduled surgery on other indications
- Provided informed consent
Who cannot join
- Pregnancy,
- Severe heart- or lung disease
- Significant musculoskeletal disease
- Chemo- or radiotherapy within three months prior to the operation
- Systemic corticosteroid medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Giant Ventral Incisional Hernia: Characteristics of Abdominal Muscle-matrix, and Effect of Hernia Repair on Abdominal Wall Function, Respiratory Performance and Quality of Life
One of five patients undergoing open abdominal surgery develops an abdominal wall defect (incisional hernia) as a late complication. A fraction of these are "giant" hernia with a fascial defect beyond 10 cm. These patients are physically severely impaired, and surgical treatment is complex.
Correction of giant incisional hernias including a relatively new and minimally invasive technique, (endoscopic components separation) offers promising results. This procedure allows the abdominal muscles to be joined centrally restoring the integrity of the abdominal wall.
Read more
The treatment of patients with giant hernia is now centralized at Bispebjerg Hospital allowing for a joint study between surgeons, pulmonologists, and sports medicine researchers to define the functional and biophysical outcome from hernia repair. We hypothesize that the abdominal muscle function is significantly optimized after restoration of the abdominal wall using this technique, and that muscular function is crucial for the postoperative quality of life. Moreover, we want to assess whether this operation specifically optimizes the function and protein synthesis of the abdominal wall muscles, and exerts a beneficial effect on lung function. Finally, we will investigate if the patients with giant incisional hernia may be identified by an altered composition of their connective tissue as compared with patients who do not develop incisional hernia.
This is a prospective study of two patient groups: 1) Patients with a giant incisional hernia and 2) controls undergoing open surgery on other indications. Assessment is done pre- and perioperatively and after 1 year including muscular function, lung function, abdominal wall anatomy as provided by CT-scan, and quality of life. Specified biopsies from muscles and connective tissue are examined for muscle fiber size/type and structure by various methods, including electron microscopy and atomic force microscopy. Lung function is monitored by blood gas concentrations, Chronic Obstructive Pulmonary Disease Assessment Test questionnaire, and regular spirometry analyses. The studies are carried out by Ph.D. student Kristian Kiim Jensen, and supervised by professor in surgery Lars Nannestad Jørgensen, professor in sports medicine Michael Kjær and professor in pulmonary medicine Vibeke Backer.
Read the detailed description
Overall project aim
The present study examines the abdominal skeletal muscle and connective tissue of patients with giant ventral incisional hernia (VIH), and to evaluate the effect of a new endoscopic components separation technique (CST) with abdominal muscle replacement upon the muscular function of the abdominal wall and quality of life in patients. The study relies on the following hypotheses:
- Collagen characteristics and organization are altered in patients with incisional hernia as compared with patients who do not develop incisional hernia.
- Reconstruction of the linea alba by endoscopic CST and medialization of the abdominal rectus muscles in patients with giant VIH leads to improvement of daily function, respiratory performance and quality of life.
- Abdominal wall reconstruction including CST with re-positioning of the rectus abdominis musculature increases the abdominal muscle mass and strength along with higher protein synthesis of the rectus muscles and a reduction of fibrotic skeletal muscle phenotype.
A total of 20 patients electively admitted for repair of a giant midline VIH, and 20 patients without hernias electively operated on for other indications are included. Exclusion criteria are pregnancy, severe heart- or lung disease, significant musculoskeletal disease, chemo- or radiotherapy within three months prior to the examination, and systemic corticosteroid medication. Oral and written informed consents are obtained from each participating patient.
Strength measurements of the m. rectus abdominis and the vastus lateralis of the quadriceps femoris muscle are done using a Good Strength muscle test system, both static and dynamic. The measurements are undertaken preoperatively and 1 year after surgery. A CT scan of the abdomen and thigh is done both 1 month before and 1 year after surgery to provide a detailed description of the hernia dimensions, the distance between the abdominal rectus muscles, and to determine the cross sectional area of the rectus abdominis and the vastus lateralis muscle. Lung function is determined by arterial blood gas, venous oxygen saturation, forced expiratory volume (FEV1), forced- and vital capacity (FVC, VC) including B2-receptor agonist reversal test, and maximum inspiratory- and expiratory pressure (MIP/MEP) preoperatively and 1 year postoperatively. Daily arterial blood gas is measured during postoperative admission. Lung function is determined at 1-month follow-up.
Quality of Life is assessed by the use of questionnaires. SF 36 is used for obtaining both mental and physical health scores. The St. George respiratory questionnaire and MRC are used to determine the level of daily lung impairment. Further, Carolina Comfort Scale assesses level of pain, movement limitation, and mesh sensation.
Protein turnover in both abdominal and thigh skeletal muscle is assessed by the use of a flood-primed continuous infusion of ring-13C6- phenylalanine. This will be infused four hours before surgery, and during this period 2-3 blood samples are drawn to verify stabilization of the isotope enrichment level prior to biopsy sampling. Muscle biopsy material is divided into fractions covering myofibrillar, sarcoplasmic and connective tissue proteins and analyzed using mass spectrometry to allow for calculation of protein synthesis of both contractile muscle protein and for muscle collagen. These procedures are repeated one year post surgery.
During surgery, biopsies of the linea alba, abdominal rectus muscle and the vastus lateralis muscle are taken using needle-biopsy equipment (Bergstrøm needle). One year after surgery the abdominal rectus muscle and vastus lateralis muscle again undergo the same biopsy procedure using a similar technique, but this time performed per-cutaneously under ultrasonographic guidance.
The biopsies are examined histologically for individual muscle fiber size and type (ATPase staining) as well as connective tissue and muscle structure (immunohistological examination collagen I, III and IV, laminin, desmin, tenascin-C). A section of the biopsy is used for mRNA expression by RT-PCR of COL1, COL3 and Tenascin-C. The content of collagen and both enzymatic and non-enzymatic cross-links (HP, LP and pentosidine) are determined by HPLC.
The linea alba connective tissue biopsy taken perioperative is investigated by electron microscopy for quantification of collagen fibril diameter, and atomic force microscopy to investigate fibril mechanics and 3-D structure of the connective tissue.
The change in abdominal flexor function and respiratory performance secondary to surgery is described in a paired design for both groups of patients. Quality of Life SF 36 and Carolina Comfort Scale are compared between the two groups of patients in an unpaired design and within patient groups in a paired design to assess any change induced by surgery. Differences between patient groups and change induced by surgery are assessed from the analyses on the harvested biopsy materials.
- Conditions
- Incisional Hernia
- Being tested
- Endoscopic components separation
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic components separationProcedure or surgery
Endoscopic components separation hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Giant ventral incisional hernia | Patient with a giant ventral incisional hernia (> 10 cm fascial defect) scheduled to undergo endoscopic components separation. Receives: Procedure: Endoscopic components separation | |
| Control group | Patients scheduled to undergo surgery on other indications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall strength
Change in maximal abdominal wall strength measured by Good Strength system.
Measured: Preoperative and one year postoperative
Secondary outcomes (6)
Rectus abdominis muscle protein synthesis activity
The change in activity of the protein synthesis in rectus abdominis muscles of the patients.
Measured: Preoperative and one year postoperative
Change in quality of life
Changes in quality of life measured by Carolinas Comfort Scale and SF-36
Measured: Preoperative and one year postoperative
Change in respiratory function
Change in respiratory function as measured by spirometry and maximal inspiratory and expiratory pressure.
Measured: Preoperatively, one month, and year postoperative
Maximal thigh strength
Change in maximal thigh strength as measured by Power-Rig method.
Measured: Preoperatively and one year postoperative
Rectus abdominis muscle phenotype
Changes in Rectus abdominis muscle phenotype due to hernia repair.
Measured: Preoperatively and one year postoperative
Connective tissue characteristics
Differences in connective tissue characteristics in patients with and without ventral incisional hernia.
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Kristian Kiim Jensen, Bispebjerg Hospital
- Investigators
- Lars Nannestad Jorgensen, Dr. Msc, Study chair, Digestive Disease Center, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011048
- Sponsor's protocol ID
- H-1-2013-097
- Acronym
- GIVINA
- Status last verified
- Mar 2016
- First submitted
- 10 Dec 2013
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jensen KK, Oma E, Kjaer M, Jorgensen LN, Andersen JL. Histology and Function of the Rectus Abdominis Muscle in Patients With Incisional Hernia. J Surg Res. 2020 Sep;253:245-251. doi: 10.1016/j.jss.2020.03.033. Epub 2020 May 6.
PubMed 32387572Jensen KK, Munim K, Kjaer M, Jorgensen LN. Abdominal Wall Reconstruction for Incisional Hernia Optimizes Truncal Function and Quality of Life: A Prospective Controlled Study. Ann Surg. 2017 Jun;265(6):1235-1240. doi: 10.1097/SLA.0000000000001827.
PubMed 27280505
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giant Ventral Incisional Hernia: Characteristics of Abdominal Muscle-matrix, and Effect of Hernia Repair on Abdominal Wall Function, Respiratory Performance and Quality of Life
- ClinicalTrials.gov ID
- NCT02011048
- Acronym / sponsor ID
- GIVINA / H-1-2013-097
- Conditions
- Incisional Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Dec 2013 (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.
One of five patients undergoing open abdominal surgery develops an abdominal wall defect (incisional hernia) as a late complication. A fraction of these are "giant" hernia with a fascial defect beyond 10 cm. These patients are physically severely impaired, and surgical treatment is complex.
Correction of giant incisional hernias including a relatively new and minimally invasive technique, (endoscopic components separation) offers promising results. This procedure allows the abdominal muscles to be joined centrally restoring the integrity of the abdominal wall.
The treatment of patients with giant hernia is now centralized at Bispebjerg Hospital allowing for a joint study between surgeons, pulmonologists, and sports medicine researchers to define the functional and biophysical outcome from hernia repair. We hypothesize that the abdominal muscle function is significantly optimized after restoration of the abdominal wall using this technique, and that muscular function is crucial for the postoperative quality of life. Moreover, we want to assess whether this operation specifically optimizes the function and protein synthesis of the abdominal wall muscles, and exerts a beneficial effect on lung function. Finally, we will investigate if the patients with giant incisional hernia may be identified by an altered composition of their connective tissue as compared with patients who do not develop incisional hernia.
This is a prospective study of two patient groups: 1) Patients with a giant incisional hernia and 2) controls undergoing open surgery on other indications. Assessment is done pre- and perioperatively and after 1 year including muscular function, lung function, abdominal wall anatomy as provided by CT-scan, and quality of life. Specified biopsies from muscles and connective tissue are examined for muscle fiber size/type and structure by various methods, including electron microscopy and atomic force microscopy. Lung function is monitored by blood gas concentrations, Chronic Obstructive Pulmonary Disease Assessment Test questionnaire, and regular spirometry analyses. The studies are carried out by Ph.D. student Kristian Kiim Jensen, and supervised by professor in surgery Lars Nannestad Jørgensen, professor in sports medicine Michael Kjær and professor in pulmonary medicine Vibeke Backer.
Detailed description
Overall project aim
The present study examines the abdominal skeletal muscle and connective tissue of patients with giant ventral incisional hernia (VIH), and to evaluate the effect of a new endoscopic components separation technique (CST) with abdominal muscle replacement upon the muscular function of the abdominal wall and quality of life in patients. The study relies on the following hypotheses:
- Collagen characteristics and organization are altered in patients with incisional hernia as compared with patients who do not develop incisional hernia.
- Reconstruction of the linea alba by endoscopic CST and medialization of the abdominal rectus muscles in patients with giant VIH leads to improvement of daily function, respiratory performance and quality of life.
- Abdominal wall reconstruction including CST with re-positioning of the rectus abdominis musculature increases the abdominal muscle mass and strength along with higher protein synthesis of the rectus muscles and a reduction of fibrotic skeletal muscle phenotype.
A total of 20 patients electively admitted for repair of a giant midline VIH, and 20 patients without hernias electively operated on for other indications are included. Exclusion criteria are pregnancy, severe heart- or lung disease, significant musculoskeletal disease, chemo- or radiotherapy within three months prior to the examination, and systemic corticosteroid medication. Oral and written informed consents are obtained from each participating patient.
Strength measurements of the m. rectus abdominis and the vastus lateralis of the quadriceps femoris muscle are done using a Good Strength muscle test system, both static and dynamic. The measurements are undertaken preoperatively and 1 year after surgery. A CT scan of the abdomen and thigh is done both 1 month before and 1 year after surgery to provide a detailed description of the hernia dimensions, the distance between the abdominal rectus muscles, and to determine the cross sectional area of the rectus abdominis and the vastus lateralis muscle. Lung function is determined by arterial blood gas, venous oxygen saturation, forced expiratory volume (FEV1), forced- and vital capacity (FVC, VC) including B2-receptor agonist reversal test, and maximum inspiratory- and expiratory pressure (MIP/MEP) preoperatively and 1 year postoperatively. Daily arterial blood gas is measured during postoperative admission. Lung function is determined at 1-month follow-up.
Quality of Life is assessed by the use of questionnaires. SF 36 is used for obtaining both mental and physical health scores. The St. George respiratory questionnaire and MRC are used to determine the level of daily lung impairment. Further, Carolina Comfort Scale assesses level of pain, movement limitation, and mesh sensation.
Protein turnover in both abdominal and thigh skeletal muscle is assessed by the use of a flood-primed continuous infusion of ring-13C6- phenylalanine. This will be infused four hours before surgery, and during this period 2-3 blood samples are drawn to verify stabilization of the isotope enrichment level prior to biopsy sampling. Muscle biopsy material is divided into fractions covering myofibrillar, sarcoplasmic and connective tissue proteins and analyzed using mass spectrometry to allow for calculation of protein synthesis of both contractile muscle protein and for muscle collagen. These procedures are repeated one year post surgery.
During surgery, biopsies of the linea alba, abdominal rectus muscle and the vastus lateralis muscle are taken using needle-biopsy equipment (Bergstrøm needle). One year after surgery the abdominal rectus muscle and vastus lateralis muscle again undergo the same biopsy procedure using a similar technique, but this time performed per-cutaneously under ultrasonographic guidance.
The biopsies are examined histologically for individual muscle fiber size and type (ATPase staining) as well as connective tissue and muscle structure (immunohistological examination collagen I, III and IV, laminin, desmin, tenascin-C). A section of the biopsy is used for mRNA expression by RT-PCR of COL1, COL3 and Tenascin-C. The content of collagen and both enzymatic and non-enzymatic cross-links (HP, LP and pentosidine) are determined by HPLC.
The linea alba connective tissue biopsy taken perioperative is investigated by electron microscopy for quantification of collagen fibril diameter, and atomic force microscopy to investigate fibril mechanics and 3-D structure of the connective tissue.
The change in abdominal flexor function and respiratory performance secondary to surgery is described in a paired design for both groups of patients. Quality of Life SF 36 and Carolina Comfort Scale are compared between the two groups of patients in an unpaired design and within patient groups in a paired design to assess any change induced by surgery. Differences between patient groups and change induced by surgery are assessed from the analyses on the harvested biopsy materials.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giant ventral incisional hernia | – | Procedure: Endoscopic components separationPatient with a giant ventral incisional hernia (> 10 cm fascial defect) scheduled to undergo endoscopic components separation. |
| Control group | – | –Patients scheduled to undergo surgery on other indications. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to the outpatient clinic at Digestive Disease Center, Bispebjerg Hospital.
Key inclusion criteria (3 listed)
- Giant ventral incisional hernia with fascial defect > 10 cm
- Scheduled surgery on other indications
- Provided informed consent
Key exclusion criteria (5 listed)
- Pregnancy,
- Severe heart- or lung disease
- Significant musculoskeletal disease
- Chemo- or radiotherapy within three months prior to the operation
- Systemic corticosteroid medication
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 |
|---|---|---|
| Endoscopic components separationEndoscopic components separation hernia repair | Procedure or surgery | Giant ventral incisional hernia |
Primary outcome
Abdominal wall strength
Time frame: Preoperative and one year postoperative
Change in maximal abdominal wall strength measured by Good Strength system.
6 secondary outcomes
Rectus abdominis muscle protein synthesis activity
Time frame: Preoperative and one year postoperative
Change in quality of life
Time frame: Preoperative and one year postoperative
Change in respiratory function
Time frame: Preoperatively, one month, and year postoperative
Maximal thigh strength
Time frame: Preoperatively and one year postoperative
Rectus abdominis muscle phenotype
Time frame: Preoperatively and one year postoperative
Connective tissue characteristics
Time frame: Perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Derived from this study: PubMed 32387572Jensen KK, Oma E, Kjaer M, Jorgensen LN, Andersen JL. Histology and Function of the Rectus Abdominis Muscle in Patients With Incisional Hernia. J Surg Res. 2020 Sep;253:245-251. doi: 10.1016/j.jss.2020.03.033. Epub 2020 May 6.
- Derived from this study: PubMed 27280505Jensen KK, Munim K, Kjaer M, Jorgensen LN. Abdominal Wall Reconstruction for Incisional Hernia Optimizes Truncal Function and Quality of Life: A Prospective Controlled Study. Ann Surg. 2017 Jun;265(6):1235-1240. doi: 10.1097/SLA.0000000000001827.
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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.
Lars Nannestad Jorgensen, Dr. Msc study chair
Digestive Disease Center, Bispebjerg 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 Incisional Hernia, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal wall strength (time frame: Preoperative and one year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02011048, which also lists 2 linked publications.
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 29 Mar 2016.