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Hernia clinical trials

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NCT ID: NCT04132986 Recruiting - Clinical trials for Ventral Hernia Repair

Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

Start date: April 1, 2019
Phase:
Study type: Observational

The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery. The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months. The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.

NCT ID: NCT04114578 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia

Start date: October 1, 2019
Phase:
Study type: Observational

CDH is associated with lung hypoplasia, pulmonary hypertension, and left ventricular hypoplasia. Use of new STE techniques (heart ultrasound) showed that CDH newborns have decreased LV size and function, potentially explaining the non-response to iNO, and that these cardiac findings were associated with poor outcomes. Our hypothesis: CDH newborns persist to have some degree of LV hypoplasia in the pediatric and adolescent life and pulmonary pressures remain increased during growth. Patients with decreased cardiac performance by STE and/or with PH have higher concomitant neonatal or pediatric morbidities and altered neurodevelopmental profile

NCT ID: NCT04096170 Recruiting - Clinical trials for Hernia, Paraesophageal

Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo

PEH
Start date: June 21, 2018
Phase: Phase 4
Study type: Interventional

We aim to study the impact of perioperative IV lidocaine on postoperative pain control in patients undergoing paraesophageal hernia repair. This is in the context of an established ERAS protocol. We wish to study the effect of IV Lidocaine on postoperative short and long-term outcomes, including patients' length of stay postoperative mortality, morbidity, and quality of life. We will compare this to our standard pain management.

NCT ID: NCT04088253 Recruiting - Umbilical Hernia Clinical Trials

Umbilical Hernial Repair Using IPOM

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique

NCT ID: NCT04074200 Recruiting - Inguinal Hernia Clinical Trials

Pain and Quality of Life After Inguinal Hernia Repair

PREPARE
Start date: August 26, 2019
Phase:
Study type: Observational

This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.

NCT ID: NCT04059640 Recruiting - Inguinal Hernia Clinical Trials

PMCF Study of LiquiBand FIX8® OHMF Device

LBF8-Open
Start date: December 7, 2021
Phase: N/A
Study type: Interventional

Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.

NCT ID: NCT04052828 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

FETO
Start date: April 5, 2021
Phase: N/A
Study type: Interventional

This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine. This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.

NCT ID: NCT03980717 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH

Start date: August 9, 2019
Phase: N/A
Study type: Interventional

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development. Fetal tracheal occlusion (FETO), using a fetoscopically delivered and removed balloon device, has been used to temporarily occlude the trachea and increase lung distension in CDH to allow the lungs to develop and has been shown to increase survival at birth. The role of FETO in the resolution of pulmonary hypertension in fetuses with severe left- and right- sided CDH remains unclear. Our recent observation that FETO is associated with a higher proportion of infants who resolve their pulmonary hypertension by the age of 1 year as compared with those who have not had FETO, is based on a retrospective cohort study, which, as with any such design, has some intrinsic limitations. Thus, a prospective cohort study that is appropriately powered to confirm or disprove this encouraging observation is needed. If our preliminary observation is confirmed, resolution of PH by the age of 1 year could be added to the benefits of the FETO procedure in severe left and right-sided CDH cases. The investigators will perform 40 FETO procedures on fetuses diagnosed prenatally with severe right- or left-sided CDH, and outcome data will be compared with that of a control group of severe right- or left-sided CDH who will not undergo the FETO procedure because of medical or social issues. Because the prevalence of left-sided CDH is higher than right-side CDH, the investigators will perform 25 FETO procedures in left sided CDH and 15 in right-sided CDH, and these outcomes will be compared to a cohort of 40 non FETO cases.

NCT ID: NCT03972956 Recruiting - Colorectal Cancer Clinical Trials

Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease

Start date: December 23, 2020
Phase:
Study type: Observational

The purposes of this study are to collect and store samples including blood, normal and tumor tissue from patients with colorectal cancer or gastric cancer, to collect and store samples including blood and/or normal gastrointestinal tissue (if available) from patients with non-malignant disease (including, but not limited to, inflammatory bowel disease (IBD), gastric ulcer, hemorrhoids or hernia), and to create a database for the collected samples and allow access to relevant clinical information for current and future protocols.

NCT ID: NCT03918798 Recruiting - Hernia, Inguinal Clinical Trials

The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population

Start date: February 14, 2019
Phase: Phase 2
Study type: Interventional

Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric population subjected to peripheral nerve block due to Inguinal hernia repair or Flat foot surgery. The present Protocol is part of an extensive Pediatric Investigational Plan (PIP) in the contest of the marketing authorization application of chloroprocaine use for perineural block. The PDCO has adopted a positive opinion.