Clinical Trial: Giant Ventral Incisional Hernia: Abdominal Wall Function, Respiratory Performance and Quality of Life

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

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

Detailed Summary:

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 syst
Sponsor: Bispebjerg Hospital

Current Primary Outcome: Abdominal wall strength [ Time Frame: Preoperative and one year postoperative ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Rectus abdominis muscle protein synthesis activity [ Time Frame: Preoperative and one year postoperative ]
  The change in activity of the protein synthesis in rectus abdominis muscles of the patients.
• Change in quality of life [ Time Frame: Preoperative and one year postoperative ]
  Changes in quality of life measured by Carolinas Comfort Scale and SF-36
• Change in respiratory function [ Time Frame: Preoperatively, one month, and year postoperative ]
  Change in respiratory function as measured by spirometry and maximal inspiratory and expiratory pressure.
• Maximal thigh strength [ Time Frame: Preoperatively and one year postoperative ]
  Change in maximal thigh strength as measured by Power-Rig method.
• Rectus abdominis muscle phenotype [ Time Frame: Preoperatively and one year postoperative ]
  Changes in Rectus abdominis muscle phenotype due to hernia repair.
• Connective tissue characteristics [ Time Frame: Perioperatively ]
  Differences in connective tissue characteristics in patients with and without ventral incisional hernia.

Original Secondary Outcome:

• Rectus abdominis muscle protein synthesis activity [ Time Frame: Preoperative and one year postoperative ]
  The change in activity of the protein synthesis in rectus abdominis muscles of the patients.
• Change in quality of life [ Time Frame: Preoperative and one year postoperative ]
  Changes in quality of life measured by Carolinas Comfort Scale and SF-36
• Change in respiratory function [ Time Frame: Preoperatively and one year postoperative ]
  Change in respiratory function as measured by spirometry and maximal inspiratory and expiratory pressure.
• Maximal thigh strength [ Time Frame: Preoperatively and one year postoperative ]
  Change in maximal thigh strength as measured by Power-Rig method.
• Rectus abdominis muscle phenotype [ Time Frame: Preoperatively and one year postoperative ]
  Changes in Rectus abdominis muscle phenotype due to hernia repair.
• Connective tissue characteristics [ Time Frame: Perioperatively ]
  Differences in connective tissue characteristics in patients with and without ventral incisional hernia.

Information By: Bispebjerg Hospital

Dates:
Date Received: December 10, 2013
Date Started: November 2013
Date Completion:
Last Updated: March 28, 2016
Last Verified: March 2016