Incisional Hernia Clinical Trial
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.
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.
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:
1. Collagen characteristics and organization are altered in patients with incisional
hernia as compared with patients who do not develop incisional hernia.
2. 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.
3. 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.
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Observational Model: Case Control, Time Perspective: Prospective
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