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Hernia clinical trials

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NCT ID: NCT06306976 Enrolling by invitation - Clinical trials for Ventral Incisional Hernia

Shear-Wave Elastography

ELASTOGRAPHY
Start date: March 2024
Phase: N/A
Study type: Interventional

Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR. Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure. Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension.

NCT ID: NCT06151704 Enrolling by invitation - Clinical trials for Radiculopathy Lumbar

The Effect of High-power Laser Therapy on Pain, Functional Disability, Range of Motion and Pressure Pain Threshold in Subjects With Radicular Low Back Pain Due to Intervertebral Disc Herniation

Start date: May 9, 2022
Phase: N/A
Study type: Interventional

Low back pain is the predominant cause of disability on a global scale. In the year 2015, the worldwide point prevalence of activity-limiting low back pain stood at 7·3%, suggesting that at any given moment, 540 million individuals were afflicted. In that same year, low back pain emerged as the primary cause of involuntary labor leave and premature retirement within Europe. In the United States, 44% of patients have utilized their health insurance for low back pain at least once, and 1 to 2% (approximately 3 million individuals) exhibit symptoms of sciatica as a result of a lumbar intervertebral disc herniation. Given the prevalence of disorders attributable to L4-L5 and L5-S1 intervertebral disc herniation, it is imperative to consider the potential risks associated with both surgical and non-surgical medical interventions, such as corticosteroid injections. Laser therapy emerges as a viable modality within the realm of physical therapy, particularly in the mitigation of inflammation. The modulating effects of laser therapy on inflammation have been documented, with no significant side effects reported thus far. Should the efficacy of laser therapy be substantiated, it could be incorporated into the suite of treatments endorsed by authoritative guidelines pertaining to back pain. Patients afflicted with radicular back pain have been the beneficiaries of assistance from physiotherapists possessing specialized knowledge in effective dosimetry. The objectives of this assistance include the amelioration of pain symptoms, the enhancement of functional indicators, the augmentation of the range of motion, and the modulation of the pressure pain threshold, all without the concern of side effects. Furthermore, adherence to the correct treatment protocol is of paramount importance. The main objective of this study is to evaluate the effect of active high-power laser compared to sham laser on pain, disability, range of motion, and pressure pain threshold in patients with radicular low back pain due to lumbar intervertebral disc herniation.

NCT ID: NCT06101979 Enrolling by invitation - Incisional Hernia Clinical Trials

A Prospective Study of Fortiva in Hernia Repair

Start date: November 15, 2023
Phase:
Study type: Observational

The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.

NCT ID: NCT05962346 Enrolling by invitation - Clinical trials for Congenital Diaphragmatic Hernia

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

FETO
Start date: May 2025
Phase: N/A
Study type: Interventional

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

NCT ID: NCT05807763 Enrolling by invitation - Clinical trials for Paraesophageal Hernia

Fundoplication in Laparoscopic PEH Repair Based on FLIP

PEHFLIP
Start date: February 22, 2023
Phase: N/A
Study type: Interventional

Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.

NCT ID: NCT05070572 Enrolling by invitation - Inguinal Hernia Clinical Trials

Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

Start date: January 1, 2021
Phase:
Study type: Observational

This study serves as a pilot study with the intention to to measure intraabdominal pressure, lactic acid, and urine output in obese individuals undergoing laparoscopic inguinal hernia repair. By measuring these values, the investigators aim to look for correlations between metrics and determine an accurate and precise measurement of IAP during laparoscopic hernia surgery using the Accuryn Monitoring System. By obtaining accurate and precise measurements of IAP during surgery the investigators will be to compare measurements to previous IAP data obtained during daily activities and strenuous movements and any associations with inguinal hernia recurrence.

NCT ID: NCT05023174 Enrolling by invitation - Clinical trials for Reflux, Gastroesophageal

Platelet Rich Plasma in Hiatal Hernia Repair

PPR-HHR
Start date: October 18, 2021
Phase: N/A
Study type: Interventional

Rationale: Gastroesophageal reflux disease (GERD) is a common disease caused by a dysfunctional lower esophageal sphincter and an abnormal esophageal hiatus or hiatal hernia. Approximately 30% of large hiatal hernias will recur after surgery, in part due to weak connective tissue at the hiatus. Platelet rich plasma (PRP) is a promising autologous therapy that may address this shortcoming by substantially enhancing wound healing of the hiatus after repair. Intervention: PRP will be applied to mesh used in hiatal hernia repair. Objectives: The objective of this study is to determine the efficacy of PRP in hiatal hernia compared to traditional hernia repair without PRP. Study population: 150 patients 18 years and older with large (>5cm) paraesophageal hernias. Study methodology and study arms: a 1:1 allocation ration will be used to randomly assign 75 patients to the experimental arm (PRP with mesh) and 75 patients to the control arm (mesh only). Study outcomes: The primary outcome will be 1-year postoperative hernia recurrence based on video esophagram and/or upper endoscopy. The secondary outcome will be GERD-Health Related Quality of Life (GERD-HRQL) scores and dysphagia scores at 6 and 12 months. Follow-up: Patients who undergo fundoplication and hiatal hernia repair with mesh are seen in clinic for follow-up at two weeks, six weeks, six months, one year, and annually thereafter. Video esophagram or upper endoscopy will be performed at 1 year after surgery to assess the primary outcome. The investigators secondary outcome of reduction in GERD-HRQL score will be determined by a difference in the GERD-HRQL score from the preoperative score to the postoperative scores taken at 6 months and 1 year. The investigators secondary outcome of dysphagia will be determined by EAT-10 scores taken at 6 months and 1 year. Statistics/Analysis: Descriptive statistics will be used. Intention to treat and per protocol analyses will be performed. Frequentist and Bayesian statistical analyses will be used to determine statistically and clinically important outcomes.

NCT ID: NCT04785430 Enrolling by invitation - Inguinal Hernia Clinical Trials

Incarceration Risk Factors in Inguinal Hernia.

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.

NCT ID: NCT03105895 Enrolling by invitation - Incisional Hernia Clinical Trials

Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

VISIBLE
Start date: September 2016
Phase: N/A
Study type: Observational [Patient Registry]

It has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. There still some debate about which is the best position to place this mesh: onlay or sublay. In Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall closure. The investigators have planned to include 200 patients in a multi center study using an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be patients with risk factors for the development of an incisional hernia. The incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. The incidence of surgical sites occurrences and pain will be also assessed.

NCT ID: NCT03025932 Enrolling by invitation - Hiatal Hernia Large Clinical Trials

Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

Start date: January 2016
Phase:
Study type: Observational

Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.