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Hiatal Hernia clinical trials

View clinical trials related to Hiatal Hernia.

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NCT ID: NCT04695171 Recruiting - Clinical trials for Gastro Esophageal Reflux

LINX Reflux Management System or Fundoplication Clinical Study in Patients With Hiatal Hernia >3 cm

Start date: January 14, 2021
Phase:
Study type: Observational [Patient Registry]

The cohort registry is both retrospective and prospective, multicenter surveillance of subjects who underwent a prior hiatal hernia repair and Magnetic Sphincter Augmentation or fundoplication construction more than 2 years prior to initial study visit.

NCT ID: NCT04591860 Not yet recruiting - Hiatal Hernia Clinical Trials

A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh). The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.

NCT ID: NCT04450628 Recruiting - Hiatal Hernia Clinical Trials

Esophagogastric Junction Distensibility During Hiatal Hernia Repair

Start date: September 28, 2020
Phase: N/A
Study type: Interventional

The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.

NCT ID: NCT04282720 Completed - Hiatal Hernia Clinical Trials

SurgiMend Mesh at the Hiatus

Start date: March 31, 2020
Phase: N/A
Study type: Interventional

Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data. Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.

NCT ID: NCT04152798 Completed - Clinical trials for Gastroesophageal Reflux Disease

Approach to Hiatal Hernia Repair Based on Collagen Study

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire. Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.

NCT ID: NCT03776669 Recruiting - Morbid Obesity Clinical Trials

Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients

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

Background: Obesity and hiatal hernia are both risk factors of gastroesophageal reflux disease (GERD), and the incidence of hiatal hernia is much higher in morbidly obese patients. Many believe that higher intra-abdominal pressure with higher esophagogastric junction (EGJ) pressure gradient in morbidly obese patients is the main mechanism accounting for the occurrence of GERD. Hiatal hernia, on the other hand, is associated with structure abnormality of EGJ. Sleeve gastrectomy (SG) has been becoming a standalone bariatric surgery for decades, and it has been proved to effectively induce long-term weight loss in morbidly obese patients. Some studies found morbidly obese patients benefited from resolution of GERD after SG, however, other studies had the opposite findings. Some morbidly obese patients had aggravating GERD or de novo GERD after SG. The mechanism is still unclear now. It might result from removal of fundus and sling muscular fibers of EGJ, increased intra-gastric pressure (IIGP), and hiatal hernia after surgery. High resolution impedance manometry (HRIM) is used to access esophageal and EGJ function objectively. Impedance reflux was more frequently observed in patients having gastroesophageal reflux (GER) symptoms after SG. In addition, previous studies also found decreased EGJ resting pressure, decreased length of lower esophageal sphincter (LES), and presence of hiatal hernia were associated with more GERD after SG. Objective: To evaluate the long-term EGJ function and GERD in morbidly obese patients with hiatal hernia receiving laparoscopic sleeve gastrectomy (LSG) with or without hiatal hernia repair (HHR).

NCT ID: NCT03730233 Completed - Hiatal Hernia Clinical Trials

Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

Start date: January 11, 2006
Phase: N/A
Study type: Interventional

One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of > 2 cm axial length, were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia. Secondary outcomes were per-and postoperative complications and courses, symptomatic recurrence rate, use of PPI, postoperative oesophageal acid exposure and Quality of Life.

NCT ID: NCT02923362 Active, not recruiting - Clinical trials for Gastroesophageal Reflux Disease

Registry of Outcomes From AntiReflux Surgery

ROARS
Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.

NCT ID: NCT02436681 Completed - Hiatal Hernia Clinical Trials

Miromatrix Biological Mesh for Hiatal Hernia Repair

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

Miromatrix Medical has developed MIROMESH® - a new, noncrosslinked, acellular mesh derived from the highly vascularized porcine liver. MIROMESH received FDA 510(k) clearance with an indication for reinforcement of soft tissue on March 31, 2014 under K134033. This study will serve to provide clinicians with high-quality clinical data in order to provide them with a higher degree of confidence when selecting MIROMESH for hiatal hernia repair.

NCT ID: NCT02328248 Active, not recruiting - Hiatal Hernia Clinical Trials

Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.