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NCT06551077
This study will be a prospective observation study of the use of PoRSHA for repair in patients with challenging paraesophageal hernias. One of the most challenging problems facing foregut surgeons is the large and complex paraesophageal hernia (PEH) repair in the older patient. The investigator has demonstrated good outcomes and durability with the initial use of a novel permanent autologous vascularized biologic fascial flap to reconstruct the diaphragmatic hiatus following standard hiatal hernia repair in selected patients. This technique is called a posterior rectus sheath flap hiatal augmentation or PoRSHA, which is performed to enhance the hiatal repair for large (type III and IV) and recurrent PEH. The investigator believes by using the patient's autologous vascularized and peritonealized fascia at the hiatal defect, PoRSHA could increase the strength and restore the hiatal complex properties in ways that synthetic mesh, or a primary repair cannot. The hypothesis is that PoRSHA is a unique technique that has the potential to supplant current approaches to primary hiatal closure in select cases. By augmenting the hiatal closure with a vascularized fascial sheath, PoRSHA provides the tensile strength needed for the attenuated defects in large and complex PEHs.
NCT01799967
This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.
NCT06725433
Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation Participants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use
NCT05807763
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.
NCT03058731
This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.
NCT00786084
In 2006 this research group reported their initial findings of a multi-center prospective trial comparing primary repair and primary repair buttressed with a biologic mesh made from porcine small intestinal submucosa (SIS). We were able to accrue 108 patients from 7/2002-3/2005 and followed each patient over 6 months and performed an UGI to check the durability of the repair and rule out a recurrence. The results suggested a significant benefit for the use of SIS mesh in the short-term, with the primary group having a 26% recurrence rate and the mesh group a 9% recurrence rate. While these results are encouraging, it is important to know what is the durability and the longer term benefits of the use of SIS mesh. For this reason we propose a follow-up of the original study patients with the same outcome measures (symptom questionnaire, SF-36, and UGI). This should give us a very good idea about the long-term success of laparoscopic PEH repair with primary and SIS mesh.