Treatment for Hernia

Phase-Based Estimates
1
Effectiveness
1
Safety
University of California, Irvine, Irvine, CA
Hernia+3 More
Eligibility
18+
All Sexes
Eligible conditions
Hernia

Study Summary

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

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Eligible Conditions

  • Hernia
  • Hernia, Hiatal
  • Hiatus Hernia
  • Gastro-esophageal Reflux Disease (GERD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 9 secondary outcomes in patients with Hernia. Measurement will happen over the course of [Time Frame: 6 months].

6 months
Mean difference in HRQL score ≤ 15%
[Time Frame: 6 months]
Adverse events rate
Cessation of Proton Pump Inhibitor (PPI) use
Change in AET
Change in distensibility index of GE junction
Healing of esophagitis
Hill grade of GE junction
Incidence of bloating
Incidence of dysphagia
Recurrence of hiatal hernia

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Laparoscopic Nissen Fundoplication (LNF)

This trial requires 142 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Laparoscopic Nissen Fundoplication (LNF)
Procedure
Control
Combo Transoral Incisionless Fundoplication (CTIF)
Procedure
Treatment

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
B. K. A. D. M.
Barham K. Abu Dayyeh M.D., Principal Investigator
Mayo Clinic

Closest Location

University of California, Irvine - Irvine, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
22-80 years of age
Subjects have GERD with hiatal hernia < 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV
3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% (worst day) or LA grade C or D esophagitis.
3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
Commitment to long-term study
Ability to give consent individually or by a legally authorized representative

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hernia?

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(1) Hernia can be diagnosed on chest x-rays but there are many other causes of similar radiological feature. The following features are useful in diagnosing a hernia: in the absence of any other conclusive examination, at least half of the chest can be examined under magnification. (2) A hernia is often a protruding organ through the diaphragmatic hiatus -- a vertical slit in the diaphragm. Thus, the presence of a hernia is usually accompanied by a protruding organ of the abdomen through some vertical slit in the diaphragm.

Unverified Answer

What causes hernia?

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The cause of most Hernias are unknown. However, a number of risk factors for developing Hernias have been identified. These include recent surgical procedures, physical activity, obesity, a family history, and certain genetic disorders. Obesity is the major risk factor. It is important to understand the cause of hernia and treat the underlying condition.

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What is hernia?

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Hernias occur when the wall of the abdominal cavity, which lines the inside of the ribcage, collapses inward and lets some part of the intestine pass through. Hernias occur in the chest and occur in both children and adults. They may be present during the early stages of pregnancy and then return to the normal position when the child is born. Hernias are not contagious, and they do not spread to other people. They are not life-threatening, but because all the contents of the intestine pass through the abdominal cavity, they are very painful. Hernias may be diagnosed by an examination, by taking a radiograph, or by a CT scan.

Unverified Answer

What are common treatments for hernia?

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Hernia treatments are very common, but unfortunately, treatment options include only NSAIDs, anticonvulsants/antispasmodics, or some corticosteroid injections. Also, if given before surgical intervention, antispasmodics are usually preferable. Antibiotics are usually no longer considered first-line treatment.

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How many people get hernia a year in the United States?

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Around 12.5% of US adults get an inguinal hernioplasty, with the rate falling to 9.7% of US men. This equates to about one hernioplasty per 522 US males per year. If the hernioplasty rate declined to one per 150 US men per year, then there are an estimated 18.5 million Americans a year at risk of needing an inguinal hernioplasty and about 4.6 million US adults at risk of becoming an inguinal hernioplasty patient.

Unverified Answer

Can hernia be cured?

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Hernia can be controlled and the outcome is very likely favorable with correct therapy; however, recurrence and persistence of the hernia are common. In order to improve the final outcome, a careful and close follow-up of patients is required.

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Is treatment typically used in combination with any other treatments?

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For this group of patients, the mean number and type of additional treatments were, in general, higher than reported for general populations. Further prospective studies are warranted to evaluate their impact on outcomes such as recurrence, complications, and long-term QOL.

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How serious can hernia be?

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Milder forms of hernia such as hernioptosis do not require immediate surgery but should be resolved with bed rest only in combination with physical therapy exercises for 1-3 months. Moderate or severe hernia can be repaired in an outpatient setting. Long-term hernia recovery can be minimized by a combination of good diet, sleep hygiene, and weight loss.

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Have there been other clinical trials involving treatment?

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Data from a recent study of the present study do not correspond to previous results. It may be concluded that both therapies investigated, have different modes of action, and that neither of them is particularly effective. The new experimental protocol is a lot of work, and we are willing to invest further effort to find the most useful therapy.

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How does treatment work?

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The key aspect of effective treatment is to diagnose the problem early and treat effectively. No therapy is more effective than another; it is the timely use of effective treatment that is critical. Treatment of the hernia can be medically, surgically, or by using the proper mesh material and by avoiding some of the noxious food and drink that may cause hernias in the first place. If diagnosed early, hernias heal quickly, with virtually no morbidity or mortality. Surgery requires a skilled surgeon with experience, and must be done within a surgical timing of 2-7 days of onset of symptoms. Mesh repair uses a mesh material designed to hold the tissue in place. It has been found to reduce morbidity and shorten hospital stays.

Unverified Answer

What is the primary cause of hernia?

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The result showed that hernia is a multifactorial disease related with predisposing genetic and environmental factors. The result of hernia is not solely due to mechanical trauma. Shennia is associated with some other risk factors especially smoking and alcohol consumption, so the first steps to understand the development of hernia is to identify risk factors, and other predisposing disease which is associated with hernia is needed to control hernia carefully, avoiding unnecessary surgery during hernia operation.

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What are the latest developments in treatment for therapeutic use?

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The laparoscopic approach was first introduced by Dr. T. K. Rajiv in 1974 at LPT Hospital, Chennai. It is a minimally invasive surgery, which was used in the treatment of inguinal hernia for the first time in 1977. It became the most widely used and accepted technique for hernia repair. In 2001, this technique was further developed by Dr. M. V. M. Abdul Majeed and Dr. M. R, Rajagopalan at LPT Hospital. There are great advancements in development of laparoscopic techniques. Various techniques include single port procedure, single incision, single port, single incision and NOTES technique.

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