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Incisional Hernia clinical trials

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NCT ID: NCT02011048 Completed - Incisional Hernia Clinical Trials

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

GIVINA
Start date: November 2013
Phase: N/A
Study type: Observational

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.

NCT ID: NCT02007096 Completed - Pain, Postoperative Clinical Trials

Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

NCT ID: NCT01961687 Completed - Ventral Hernia Clinical Trials

A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

Start date: September 2013
Phase: N/A
Study type: Interventional

Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.

NCT ID: NCT01863030 Completed - Ventral Hernia Clinical Trials

A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery

Start date: May 2013
Phase:
Study type: Observational

The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following: 1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. 2. Perioperative, short-term and long-term procedural and/or device related complications. 3. Abdominal Wall Function and mobility.

NCT ID: NCT01740973 Completed - Incisional Hernia Clinical Trials

Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy

UMBI-SILS
Start date: April 2014
Phase: N/A
Study type: Observational

Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain, especially around the umbilical port is dominating the first postoperative week. Single Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative incisional pain and improve cosmetic results, but results are not convincing and the risk of formation of an umbilical trocar-site hernia is not properly investigated. This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC vs. conventional 4-port laparoscopic cholesystectomy. Methods This is a cohort registry study with prospective questionnaire and clinical follow-up on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a conventional laparoscopic cholecystectomy (consecutively from one month before and after SILC. They are matched for age, gender, date of operation, and surgeons skills (database from intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation (operation for a umbilical hernia or clinical hernia). The H0 hypothesis is that there is not difference between SILC and conventional. Exclusion criteria are: death, operation for acute cholecystitis. The included patients will be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia, and perioperative data that we do not have in the database. Futhermore those patients who suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis. Furthermore we patients are asked to report if they have chronic pain and/or discomfort.

NCT ID: NCT01740882 Completed - Incisional Hernia Clinical Trials

Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks

ABSTACK
Start date: November 2013
Phase: N/A
Study type: Observational

Laparoscopic incisional hernia repair a variety of fixation methods has been proposed to ensure the correct and stable intra-abdominal placement of the mesh, in order to prevent recurrence, but on the other hand avoiding long-term pain and discomfort. The optimal method is unclear. In Denmark the investigators have a nationwide database that records 80% of all ventral hernia repairs. The investigators combine data from the Danish Hernia Database, the National Patient Registry, and prospective questionnaire and clinical follow-up in order to get the true recurrence rate (clinical and reoperation rate) and the degree of long-term discomfort. Purpose The purpose of this national prospective kohort study is to compare the risk of developing recurrence of incisional hernia after laparoscopic incisional hernia repair with either absorbable or non-absorbable tacks, and to investigate possible. late complaints in terms of pain and discomfort after the two mesh fixation devices. The investigators include 355 laparoscopic incisional hernia repairs with absorbable tacks and 726 with non-absorbable tacks. It is expected that about 300 patients will be offered physical examination. Material and Method Register-based cohort study of perioperative entry of patient data and prospective questionnaire follow-up and depending on the answer to any. clinical trial. Follow-up is done by searching the Danish Hernia Database and the National Patient Register (to ensure data completeness) and distribution of patient questionnaire as reoperation for hernia recurrence is an underestimate of the true recurrence risk. Statistics There will be performed frequency analyzes and Kaplan Meyer statistics on the 2 groups supplemented with multivariate Cox regression analysis. Using non-parametric statistics. P <0.05 considered statistically significant.

NCT ID: NCT01622127 Completed - Clinical trials for Primary Ventral and Incisional Hernia Repair

Progrip Ventral Study for Sublay Repair

Start date: February 2012
Phase:
Study type: Observational

A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair. Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.

NCT ID: NCT01430676 Completed - Incisional Hernia Clinical Trials

Risk Factors for Morbidity After Incisional Hernia Repairs

Start date: January 2007
Phase:
Study type: Observational

The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after incisional hernia repair.

NCT ID: NCT01349400 Completed - Incisional Hernia Clinical Trials

Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

AWARE
Start date: November 2011
Phase: N/A
Study type: Interventional

Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities.

NCT ID: NCT01289093 Completed - Inguinal Hernia Clinical Trials

Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy.

life-in
Start date: March 2011
Phase: N/A
Study type: Observational

LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a disease-specific quality of life questionnaire, designed by an American group, to monitor quality of life in patients undergoing operation for hernias. The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality of life and other well-known core-symptoms before and after herniotomies.