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Hiatal Hernia clinical trials

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NCT ID: NCT06159972 Recruiting - GERD Clinical Trials

Can EndoFLIP Improve Quality of Life Before and After Fundoplication?

Start date: January 5, 2023
Phase: N/A
Study type: Interventional

Patients with reflux disease (heart burn), or a hiatal hernia, who do not get better with medication, may have surgery to help with their symptoms. Unfortunately, there is no agreed upon way to perform the surgery. The investigators are using a new surgical instrument called the EndoFLIP which allows surgeons to take measurements during the operation. The investigators will compare the measurements obtained during surgery with a quality of life score that we will calculate from a questionnaire.

NCT ID: NCT05953428 Recruiting - Hiatal Hernia Clinical Trials

Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

Start date: November 14, 2023
Phase: N/A
Study type: Interventional

This is a prospective randomized, double-blinded, controlled trial that will enroll 75 subjects undergoing laparoscopic hiatal hernia repair surgery. Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either the opioid sparring anesthesia protocol (OSA) or the opioid based anesthesia protocol (OBA). The purpose of this study is to investigate if an opioid sparring protocol for laparoscopic hiatal hernia repair will reduce opioid consumption during discharge. Other outcomes include: postoperative VAS scores (PACU arrival, PACU discharge, hospital discharge), total in hospital opioid consumption, PACU length of stay, incidence of postoperative nausea and vomiting (PONV in PACU, postoperative day 1, during hospital stay), rehospitalization rate, rate of reoperation, rate of emergency room visit, surgeon satisfaction, and hospital cost differential.

NCT ID: NCT05710913 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Development of Machine Learning Models for the Prediction of BMI and Complications After Bariatric Surgery (CABS-Study)

Start date: January 5, 2023
Phase:
Study type: Observational

This Study aims to develop machine learning models with the ability to predict patients' BMI and complications after Bariatric Surgery (CABS-Score). This Study also aims to develop machine learning models with the ability to predict diabetic (DM II)patients' remission rate after Bariatric Surgery. The service mentioned above will be publicly available as a web-based application

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: NCT04936711 Recruiting - Shoulder Pain Clinical Trials

Pain Relief After Hiatal Hernia Repair Surgery

Start date: May 12, 2021
Phase: Phase 4
Study type: Interventional

Referred shoulder pain (pain felt when the problem is actually in a different location) is very common after laparoscopic (small, narrow cut) hernia surgery. The purpose of this study is to look at the effect of a simple back massager, which can be readily purchased online or in a store, in addition to the use of standard pain medications.

NCT ID: NCT04795934 Recruiting - GERD Clinical Trials

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

CTIF
Start date: January 26, 2021
Phase: N/A
Study type: Interventional

This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.

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: 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: 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: NCT02242526 Recruiting - Hiatal Hernia Clinical Trials

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.