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Hernia clinical trials

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NCT ID: NCT03561727 Recruiting - Incisional Hernia Clinical Trials

Risk Factors for Development of Incisional Hernia in Transverse Incisions

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

RESEARCH PROJECT OBJECTIVES The aim of this planned study is to evaluate factors, with particular reference to surgical technique of abdominal closure, accumulation of advanced glycation end products, and collagen content in the transversalis fascia, that are associated with the development of incisional hernias after transverse epigastric incisions in patients operated due to malignant tumors. RESEARCH PROJECT METHODOLOGY: The study is designed as prospective and is planned to include 392 patients undergoing abdominal surgery due to malignant tumors of the alimentary system performed through transverse incisions in the epigastrium. Primary end-point of the study is defined as the occurrence of burst abdomen during immediate postoperative period or incisional hernia over 2 year postoperative follow-up. Assessment of the association between the type of surgical technique and development of hernia will be based on comparison of mass (1 layer) continuous suture and layered (2 layers) continuous suture using slowly absorbable material and applying suture to wound length ratio of more than 4. Type of the utilized surgical technique will be based on randomization. The method of abdominal closure will remain unknown for patients and investigators assessing the presence of incisional hernias. Assessment of overall collagen content and type I to type III ratio will be performed by obtaining a fragment of tissue during operation, preparation of formalin-fixed and paraffin embedded blocks, cutting of 4-micrometer thick sections, staining with picrosirius red and immunohistochemical procedures. Images will be analyzed with dedicated computer software. Accumulation of advanced glycation end products will be evaluated indirectly by measuring skin autofluorescence utilizing a method based on the use of photodiodes. Postoperative follow-up will include the period of postoperative hospitalization and two additional control visits at 1 and 2 years after the operation. Assessment of the presence of incisional hernia will comprise clinical examination, ultrasonographical study, and analysis of images from other available radiological studies. Irrespective of the primary end-point, additional analyses will be performed concerning associations between evaluated factors and occurrence of burst abdomen and the impact of incisional hernia on patients quality of life using the EORTC QLQ C-30 questionnaires. Statistical analyses will, among other, include Kaplan-Meier method, log-rank test, Cox proportional hazards regression and logistic regression

NCT ID: NCT03526588 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)

Start date: August 1, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB) mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia (CDH).

NCT ID: NCT03512366 Recruiting - Local Anaesthesia Clinical Trials

Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia

Start date: December 9, 2017
Phase: N/A
Study type: Interventional

Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh for strengthening the defect but has been associated with complications. Another new method uses a strip of the external oblique aponeurosis to do the same.There is a necessity to conduct studies comparing the two methods of hernia repair under local anaesthesia in terms of feasibility, economic benefits, faster ambulation with less complications. The purpose of the study is to find a method that will lead to faster disposal of patients and early return to activities, thereby reducing the waiting list of patients that compromises their financial and social spheres and overwhelms the welfare system.

NCT ID: NCT03488342 Recruiting - Clinical trials for Primary Inguinal Hernia

Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Start date: September 2015
Phase: N/A
Study type: Interventional

Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the neurological plane and the muscular plane, thus better fulfilling the principle of hydrostatics.

NCT ID: NCT03475095 Recruiting - Low Back Pain Clinical Trials

Motor Control Mechanisms by CNS of Tuina in Patients With Lumbar Disk Herniation

Start date: March 10, 2018
Phase: N/A
Study type: Interventional

Lumbar disk herniation (LDH)is a prevalent health problem around the world. It can cause symptoms of low back pain, numbness or weakness.The understanding of low back pain in traditional Chinese medicine(TCM) theory"unbalanced bones and muscles"that is consistent with the description of modern medicine on LDH function pathology. Tuina is one of Diagnosis and treatment methods in TCM which has been used as a noninvasive treatment of LDH. However, the mechanism of Tuina therapy in LDH is still unclear.The purpose of this study is to establish a platform of the therapeutic effect and mechanical effect of LDH in the treatment of LDH,explore the characteristics of Tuina by the motor control in lumbar CNS,observe the patterns and regularities in the function of related brain regionin of patients with acute or chronic LDH and reveal the mechanism of Tuina of improving the control of lumbar spine CNS movement.

NCT ID: NCT03431792 Recruiting - Clinical trials for Severe Congenital Diaphragmatic Hernia

FETO With Long Tail Balloon for a Treatment of Severe CDH

LongTailFETO
Start date: August 30, 2017
Phase: N/A
Study type: Interventional

Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns. The survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. In case of an observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower and herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or lower. The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung growth in CDH fetuses avoiding the development of lung hypoplasia. Some complications after sucsessfull FETO before delivery occur because of technical difficulties during the extraction of the balloon from the trachea, leading to asphyxia, worse outcome or neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO directly related to difficulties with the removal of the intratracheal balloon. The risk of emergent balloon removal was published to be very high (39%-56%). Our new technique exploits the fetal ability to removal the intratracheal balloon which has been implanted for the treatment of severe CDH before the delivery, avoiding many risks associated with balloon extraction and a second fetoscopy. The study will be performed on 20 fetuses with severe CDH. Before the FETO the total fetal lung volume ratio (o/e TFLV) will be measured by fetal MRI (magnetic . Only CDH fetuses with 24-32 weeks' gestation with o/e TFLV < 25% or the fetuses with o/e TFLV < 35% and liver herniation will be operated Second fetal MRI should be performed in one week after the FETO. The balloon will be extracted by the fetus itself before the delivery, after puncture with 22 gauge needle under ultrasound guiding, during second fetoscopy or using the EXIT (ex utero intrapartum Treatment). Neonatal follow up 12 months.

NCT ID: NCT03355950 Recruiting - Hernia, Inguinal Clinical Trials

ASA Levels in TEP and Lichtenstein Repair Patients

Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.

NCT ID: NCT03310905 Recruiting - Clinical trials for Transplant;Failure,Kidney

Abdominal Wall Transplant

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

NCT ID: NCT03262688 Recruiting - Postoperative Pain Clinical Trials

Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair

Start date: June 16, 2017
Phase: Phase 3
Study type: Interventional

A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a stepwise fashion until appropriate doses are established for all 3 pediatric age groups (12 to <17 years, 6 to <12 years, 2 to <6 years).

NCT ID: NCT03255239 Recruiting - Ventral Hernia Clinical Trials

Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter