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Hernia, Hiatal 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: NCT06107634 Recruiting - Clinical trials for Paraesophageal Hernia

Gastropexy in the Repair of Patients With Paraesophageal Hernias

PEH3
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.

NCT ID: NCT05974722 Recruiting - GERD Clinical Trials

Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: - Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair. - Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms

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: NCT05867225 Recruiting - Large Hiatal Hernia Clinical Trials

Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia

HIATUS
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.

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: NCT04718168 Recruiting - Incisional Hernia Clinical Trials

GORE® ENFORM Biomaterial Product Study

ENF 18-06
Start date: May 17, 2021
Phase: N/A
Study type: Interventional

A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance.