Hiatal Hernia Repair for GERD Symptoms
Recruiting in Palo Alto (17 mi)
Overseen byPaul D Colavita, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Redo repairs, Emergent repairs, Varices, Connective tissue diseases, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment EndoFLIP 1.0 System EF-100 for GERD symptoms?
Antireflux surgery, which is often used to treat GERD, is generally effective, with a majority of patients experiencing relief from symptoms. However, between 10 and 20 percent of patients may need additional surgery due to recurring symptoms. This suggests that while surgical interventions can be effective, there is a possibility of needing further treatment.
12345Is hiatal hernia repair for GERD symptoms generally safe for humans?
The research articles provided do not contain specific safety data for hiatal hernia repair or the related devices like EndoFLIP 1.0 System EF-100. They discuss general surgical safety and adverse events, but not specific to this treatment.
678910How does hiatal hernia repair for GERD symptoms differ from other treatments?
Hiatal hernia repair for GERD (gastroesophageal reflux disease) symptoms is unique because it involves a surgical procedure to fix the hernia, which may help reduce reflux symptoms. Unlike medications that manage symptoms, this treatment addresses the physical cause of GERD by repairing the hernia, potentially offering a more long-term solution.
1112131415Eligibility Criteria
This trial is for adults over 18 who need elective hiatal hernia repair and fundoplication, without spastic esophageal disorders or severe esophageal dysmotility. It's not for those with surgery risks, emergent repairs, redo surgeries, connective tissue diseases like scleroderma or lupus, esophageal varices, or cases requiring Collis gastroplasty.Inclusion Criteria
I am having surgery for hiatal hernia and stomach wrap.
My esophagus functions normally, without any disorders like jackhammer esophagus or achalasia.
I am 18 years old or older.
+1 more
Exclusion Criteria
I cannot undergo surgery or endoscopy due to health risks.
I have a connective tissue disease like scleroderma or lupus.
Presence of IEM on Manometry
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Preoperative Evaluation
Standard preoperative evaluation including EGD, esophageal manometry, and UGI imaging
2-4 weeks
2 visits (in-person)
Surgery and Intraoperative Assessment
Patients undergo hiatal hernia repair and fundoplication with intraoperative impedance planimetry using EndoFLIP
1 day
1 visit (in-person)
Postoperative Follow-up
Postoperative care and symptom assessment using GERD-HRQL and Mayo Dysphagia Questionnaire at 2 and 6 weeks
6 weeks
2 visits (in-person)
Long-term Follow-up
Long-term follow-up at 6 months to assess QOL symptoms via GERD-HRQL and Mayo Dysphagia Questionnaire
6 months
1 visit (in-person)
Participant Groups
The study measures how the area where the stomach meets the esophagus changes in flexibility after hiatal hernia surgery using a device called EndoFLIP. It also looks at any links between this flexibility and life quality related to acid reflux (GERD) and swallowing difficulty.
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgeon unblindedExperimental Treatment2 Interventions
The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
Group II: Surgeon blindedActive Control1 Intervention
During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values.
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium Health - Carolinas Medical CenterCharlotte, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
Atrium HealthLead Sponsor
MedtronicIndustry Sponsor
References
Gastro-oesophageal reflux after surgical treatment of hiatal hernia with and without severe reflux complications. A follow-up study. [2004]One hundred and sixteen patients operated upon for hiatal hernia with gastro-oesophageal reflux and with or without reflux complications were postoperatively examined by personal interview, X-ray study, pH measurements and study of the oesophageal motility 1 to 10 years postoperatively. The patients without severe reflux complications were operated upon mainly with a modified Husfeldt hernia repair and the patients with complications, such as oesophageal stricture and shortening, underwent various surgical procedures. The main reason for unsatisfactory clinical results, with persistent reflux symptoms, was gastro-oesophageal reflux uncorrected by the surgical procedure. However, gastro-oesophageal reflux was detected even in completely asymptomatic patients. It was found that the reflux symptoms were influenced by the oesophageal motility. The clinical results were better and recurrence of hernia and the occurrence of pathological reflux were lower in patients operated upon for hernia without severe reflux complications. Creation of a competent antireflux barrier between the oesophagus and stomach for control of gastro-oesophageal reflux is much more difficult in patients with severe reflux complications.
Impact of Participation of Surgeons in Diagnostic Studies of Gastroesophageal Reflux Disease on Completion of Workup and Utilization of Antireflux Surgery. [2021]Introduction. Patients presenting with symptoms of gastroesophageal reflux disease (GERD) are usually evaluated by gastroenterologists who perform the diagnostic workup and determine when to refer for surgical consideration. The multiple diagnostic studies can be overwhelming, and this leads to dropouts. In a rural setting, without gastroenterology services, the surgeon can diagnose GERD and perform antireflux procedures. This study aimed to assess the completion of the required diagnostic studies and progression to surgical intervention. Methods. This is a retrospective chart review of patients who presented with GERD symptoms between August 2015 and January 2018. Standardized workup included the upper gastrointestinal study and esophagogastroduodenoscopy with concomitant wireless pH placement. High-resolution impedance manometry and the gastric emptying scan were selectively utilized. Results. 429 patients were evaluated. Proton pump inhibitors were used by 82.2% of patients. The required diagnostic workup was completed by 92.7% of all patients. Nearly 75% were suitable candidates for antireflux surgery. Approximately 2/3 of these patients proceeded with antireflux surgery. Discussion. The lack of gastroenterology services in rural hospitals provides a unique opportunity for general surgeons to diagnose and treat GERD patients locally. This avoids fragmentation of care and enables the surgeon to evaluate the entire spectrum of GERD. This structured approach results in increased completion of multiple diagnostic studies. Moreover, surgical candidates are likely to proceed with surgical intervention. Conclusion. A surgical antireflux program with diagnostic and therapeutic capabilities results in increased completion of diagnostic workup and utilization of antireflux surgery.
Reoperation after antireflux surgery: a population-based cohort study. [2021]Antireflux surgery for gastro-oesophageal reflux disease (GORD) and/or hiatal hernia is effective. Between 10 and 20 per cent of patients undergo reoperation for recurrent symptoms. Most studies are undertaken in a single centre and possibly underestimate the rate of reoperation. The aim of this nationwide population-based cohort study was to investigate long-term reoperation rates after antireflux surgery.
Gastroesophageal Reflux Disease. [2020]Prior to the advent of proton pump inhibitors, internists recommended antireflux surgery primarily for patients whose gastroesophageal reflux disease (GERD) failed to respond to medical therapy. Although many physicians still cling to the notion that antireflux surgery is a procedure best reserved for "medical failures," today this position is inappropriate. Modern medical treatments for GERD are extraordinarily effective in healing reflux esophagitis. It is uncommon to encounter patients with heartburn or esophagitis due to GERD who do not respond to aggressive antisecretory therapy. Indeed, the very diagnosis of GERD must be questioned for patients whose esophageal signs and symptoms are unaffected by the administration of proton pump inhibitors in high dosages. In the large majority of these so-called refractory patients, protracted esophageal pH monitoring reveals good control of acid reflux by the proton pump inhibitors. This finding indicates that the persistent symptoms usually are not due to acid reflux, but to other problems such as functional bowel disorders. Medical treatment fails in such patients because the diagnosis is mistaken, not because the drugs fail to control acid reflux. Modern antireflux surgery also is highly effective for controlling acid reflux, but fundoplication will not be effective for relieving symptoms in patients whose symptoms are not reflux-induced. Therefore, many patients deemed failures of modern medical therapy would be surgical failures as well. Antireflux surgery is an excellent treatment option for patients with documented GERD who respond well to medical therapy, but who wish to avoid the expense, inconvenience, and theoretical risks associated with lifelong medical treatment. Ironically, surgical therapy for GERD today is best reserved for patients who are medical successes.
Selection criteria among gastroenterologists and surgeons for laparoscopic antireflux surgery. [2015]Symptomatic gastroesophageal reflux disease (GERD) affects a substantial proportion of the American population. The diagnosis and treatment of GERD has advanced tremendously over the past 30 years. However, there remains a lack of understanding about the differences and advantages that laparoscopic antireflux surgery offers and a lack of agreement on the ideal surgical candidate. The purpose of this study was to determine whether a significant difference exists in the practice habits and selection criteria for surgery between gastroenterologists and laparoscopic surgeons.
Surgical error: ethical issues of adverse events. [2019]We all recognize and accept that adverse events occur with some frequency in surgery and that all departments meet regularly to review them. Since adverse events and "mistakes" have the potential for delaying recovery and injuring surgical patients, an ethical mandate exists to do all that can be done to prevent harm. This article suggests that there are 5 issues within the practice of surgery that have inhibited improvement in quality: (1) inadequate data about the incidence of adverse events, (2) inadequate practice guidelines or protocols and poor outcome analysis, (3) a culture of blame, (4) a need to compensate "injured" patients, and (5) difficulty in truth telling.
Incidence and Risk Factors for Mortality Following Bariatric Surgery: a Nationwide Registry Study. [2022]Although bariatric surgery (BS) is considered safe, concern remains regarding severe post-operative adverse events and mortality. Using a national BS registry, the aim of this study was to assess the incidence, etiologies, and risk factors for mortality following BS.
A perspective from clinical and business ethics on adverse events in hospitalized patients. [2018]Adverse events occur in a significant, but undetermined, number of hospitalized patients. These types of patient injuries are more often the result of faulty systems than human maleficence. A culture exists among health care providers that discourages the reporting of such events and resists the implementation of formal efforts to eliminate them. This resistance serves to perpetuate the problem. Both business and clinical ethics argue that sound reasons exist for hospitals to reduce, if not eliminate, adverse events. To do so is cost effective, particularly in a managed care environment. It is also at the heart of responsible professional behavior. Physicians are afforded an opportunity to be at the forefront in this quality improvement effort.
Pediatric Surgeon Perceptions of Participation in External Patient Safety Programs: impact on Patient Safety. [2022]Surgeons play a crucial role in preventing harm and contributing to the safety culture of their institutions. External safety data programs are designed to review adverse events and provide performance benchmarks to ameliorate future adverse events. The extent to which pediatric surgeons are aware of these programs, utilize data from these programs, and believe that they improve patient safety, is unknown.
Detection of adverse events in general surgery using the " Trigger Tool" methodology. [2022]Surgery is one of the high-risk areas for the occurrence of adverse events (AE). The purpose of this study is to know the percentage of hospitalisation-related AE that are detected by the «Global Trigger Tool» methodology in surgical patients, their characteristics and the tool validity.
Impact of concurrent hiatal hernia repair during laparoscopic sleeve gastrectomy on patient-reported gastroesophageal reflux symptoms: a state-wide analysis. [2023]Concurrent hiatal hernia repair (HHR) during laparoscopic sleeve gastrectomy (LSG) may improve gastroesophageal reflux disease (GERD) symptoms. However, patient-reported outcomes are limited, and the influence of surgeon technique remains unclear.
Repair of post-bariatric surgery, recurrent, and de novo hiatal hernias improves bloating, abdominal pain, regurgitation, and food intolerance. [2021]Post-bariatric surgery hiatal hernias are associated with a cluster of symptoms, including bloating (nausea/vomiting or fullness), abdominal pain, regurgitation, and food intolerance or dysphagia (BARF).
Impact of hiatal hernia repair technique on patient-reported gastroesophageal reflux symptoms following laparoscopic sleeve gastrectomy. [2022]Repairing a hiatal hernia at the time of laparoscopic sleeve gastrectomy (SG) can reduce or even prevent gastroesophageal reflux disease (GERD) symptoms in the post-operative period. Several different hiatal hernia repair techniques have been described but their impact on GERD symptoms after SG is unclear.
In the eye of the beholder: surgeon variation in intra-operative perceptions of hiatal hernia and reflux outcomes after sleeve gastrectomy. [2021]Hiatal hernia repair performed at the time of laparoscopic sleeve gastrectomy (LSG) may reduce post-operative reflux symptoms. It is unclear whether intra-operative diagnosis of hiatal hernia varies among surgeons or if it affects outcomes.
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy with Concomitant Hiatal Hernia Repair: an Unresolved Question. [2022]The effectiveness of the concomitant repair of hiatal hernia (HHR) during laparoscopic sleeve gastrectomy (LSG) in reducing gastroesophageal reflux disease (GERD) symptoms is still unclear. The aim of this study is to assess the effect of concomitant HHR on postoperative GERD symptoms in our patient population.