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

NCT02011048 | Completed

• 1 other identifier: H-1-2013-097
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• Abdominal wall strength

  Change in maximal abdominal wall strength measured by Good Strength system.

  Preoperative and one year postoperative

Secondary Outcomes (6)

• Rectus abdominis muscle protein synthesis activity

  Preoperative and one year postoperative

• Change in quality of life

  Preoperative and one year postoperative

• Change in respiratory function

  Preoperatively, one month, and year postoperative

• Maximal thigh strength

  Preoperatively and one year postoperative

• Rectus abdominis muscle phenotype

  Preoperatively and one year postoperative

Study Arms (2)

Giant ventral incisional hernia

Patient with a giant ventral incisional hernia (\> 10 cm fascial defect) scheduled to undergo endoscopic components separation.

Procedure: Endoscopic components separation

Control group

Patients scheduled to undergo surgery on other indications.

Interventions

Endoscopic components separation PROCEDURE

Endoscopic components separation hernia repair

Giant ventral incisional hernia

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the outpatient clinic at Digestive Disease Center, Bispebjerg Hospital.

You may qualify if:

• Giant ventral incisional hernia with fascial defect \> 10 cm
• Scheduled surgery on other indications
• Provided informed consent

You may not qualify if:

• Pregnancy,
• Severe heart- or lung disease
• Significant musculoskeletal disease
• Chemo- or radiotherapy within three months prior to the operation
• Systemic corticosteroid medication

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen Northwest, Copenhagen, 2400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 32387572 DERIVED

• Jensen 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.

  PMID: 27280505 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Skeletal muscle biopsy, connective tissue biopsy, whole blood serum

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Lars Nannestad Jorgensen, Dr. Msc

  Digestive Disease Center, Bispebjerg Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD student

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

DK (1)