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Hernia clinical trials

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NCT ID: NCT05201508 Recruiting - Recurrence Clinical Trials

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Start date: January 21, 2022
Phase: N/A
Study type: Interventional

Paraesophageal hernia causes pain, heartburn, regurgitation, anemia and in extreme, life-threatening strangulation. For symptomatic patients, laparoscopic surgery is offered which includes hiatal defect closure and antireflux surgery. However, recurrence rates are high between 12 and 42%. In order to reduce recurrences, mesh has been used with various materials and techniques with conflicting results. Non-absorbable mesh has been linked with adverse events including erosion of esophageal wall. Traditionally used biological mesh materials are expensive and therefore problematic in routine use. Use of polyglactin (Vicryl®) mesh, which degrades in 6-8 week, has been reported in paraesophageal hernia surgery. Previously, no randomized controlled trial comparing sutures only and polyglactin mesh has been performed. In this trial, the aim was to randomize total of 110 patients to receive sutures only or mesh repair. Primary outcome was recurrence of paraesophageal hernia at 6 months after the repair based on computed tomography scan. Secondary outcomes included symptomatic recurrences, reoperation rate, quality of life, reoperations up to 20-years after surgery and use of proton pump inhibitors up to 20-years after surgery.

NCT ID: NCT05201144 Recruiting - Clinical trials for Pulmonary Hypertension

A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)

Start date: September 15, 2022
Phase: Phase 2
Study type: Interventional

Congenital diaphragmatic hernia (CDH) occurs in approximately 1 in 3000 US live births, similar to the incidence seen within the Utah Birth Defects cohort. The diaphragmatic defect compromises lung growth and alters pulmonary vascular development. This is reflected postnatally as respiratory failure, pulmonary hypertension (PH) and overall cardiopulmonary dysfunction, particularly post-repair. Currently, optimal management of post-repair PH remains poorly investigated. Sildenafil citrate is a highly selective phosphodiesterase-5 inhibitor that increases cGMP levels, leading to smooth muscle relaxation and an anti-proliferative effect within the pulmonary vasculature. It is used off-label for many neonatal PH disorders, including PH associated with bronchopulmonary dysplasia and idiopathic persistent PH. Most neonates with CDH born within the Mountain West referral basin are managed at a quaternary care center, Primary Children's Hospital (PCH). Of these neonates with PH, approximately 25% have been treated with off-label sildenafil. However, neither the PCH clinical care group nor others have developed/published a standardized approach for either initiating or discontinuing sildenafil therapy in this group of patients. Thus, the aim of this study is to assess the safety and effectiveness of sildenafil therapy for PH in neonates with CDH within the Utah cohort. Given the relatively short-term outcome and small sample size for this trial, the plan is to use this data to support a larger multicenter randomized trial targeting long-term cardiopulmonary outcomes of infants with CDH and post-repair PH.

NCT ID: NCT05196503 Recruiting - Neuropathic Pain Clinical Trials

Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation

NeuroPRF
Start date: February 23, 2022
Phase: Phase 3
Study type: Interventional

The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.

NCT ID: NCT05177991 Recruiting - Inguinal Hernia Clinical Trials

Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs

Start date: March 1, 2022
Phase: Early Phase 1
Study type: Interventional

While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.

NCT ID: NCT05142618 Recruiting - Ventral Hernia Clinical Trials

Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

ABVENTURE-P
Start date: April 19, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.

NCT ID: NCT05100693 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Smart Removal for Congenital Diaphragmatic Hernia

SmartRemoval
Start date: September 8, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia.

NCT ID: NCT05094089 Recruiting - Hernia, Ventral Clinical Trials

Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

SYN 20-01
Start date: February 24, 2023
Phase:
Study type: Observational

The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application. Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of 60 months.

NCT ID: NCT05005663 Recruiting - Incisional Hernia Clinical Trials

Incisional Hernia in Infants and Children

Start date: February 2, 2007
Phase: N/A
Study type: Interventional

the study of development of incisional hernia in infants and children at a tertiary level experience.

NCT ID: NCT04986917 Recruiting - Ventral Hernia Clinical Trials

Laparoscopic Ventral Hernia Repair With Routine Defect Closure Using Su2ura® Approximation Device

Start date: January 19, 2022
Phase: N/A
Study type: Interventional

Study includes 5 visits: Screening, Baseline/Surgery, and 14 days, 3 months, 12months Follow-Ups post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 12 months post-surgery. Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered 30 min prior to skin incision. A surgical assistant will be selected by the PI from the surgical staff of the department. The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura® approximation device and fixation of mesh with tacks over the closed defect in an IPOM fashion. Based on surgeon consideration, primary umbilical hernia defects under 2 cm will be repaired with or without mesh. Study follow-up visits will take place 14 days, 3 months and 12 months post-surgery.

NCT ID: NCT04960267 Recruiting - Hernia, Inguinal Clinical Trials

Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study

DrainrTAPP
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.