Anterior Gastropexy for Hernia, Hiatal

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic Foundation, Cleveland, OH
Hernia, Hiatal+3 More
Anterior Gastropexy - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a surgery which attaches the stomach to the abdominal wall may help reduce the risk of a hernia returning.

See full description

Eligible Conditions

  • Hernia, Hiatal
  • Paraesophageal Hernia
  • Hiatal Hernia Large

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hernia, Hiatal

Study Objectives

This trial is evaluating whether Anterior Gastropexy will improve 1 primary outcome and 2 secondary outcomes in patients with Hernia, Hiatal. Measurement will happen over the course of 30 day follow up (15-45 days postop) and 1 year follow-up (6-18 months).

1 year
Paraesophageal Hernia Recurrence
Year 1
Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year
Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year

Trial Safety

Safety Progress

1 of 3

Other trials for Hernia, Hiatal

Trial Design

2 Treatment Groups

Intervention 1 (Control)
1 of 2
Intervention 2 (Treatment)
1 of 2
Active Control
Experimental Treatment

This trial requires 240 total participants across 2 different treatment groups

This trial involves 2 different treatments. Anterior Gastropexy 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.

Intervention 2 (Treatment)
Procedure
Anterior gastropexy will be performed.
Intervention 1 (Control)No anterior gastropexy will be performed.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Who is running the study

Principal Investigator
C. P.
Prof. Clayton Petro, Assistant Professor
The Cleveland Clinic

Closest Location

Cleveland Clinic Foundation - Cleveland, OH

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:
The crura (attachments at the sides of the clitoris) need to be rejoined at the time of surgery. show original
Age 18+
phonecall I am able to participate in a follow-up phonecall. show original
Symptomatic paraesophageal hernia
Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy
The surgery involves repairing a hernia near the stomach by making a small incision in the abdomen and inserting a thin, lighted tube with a camera on the end (a laparoscope) show original

Patient Q&A Section

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

"The present data offer estimates of hernia rates for each of these regions. Estimates of the age distribution of hernia cases in a large community and of expected incidence rates are presented." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hernia?

"There is no one-size fits-all approach to hernia repair. Some hernias may be dealt with via laparoscopic techniques, while others may be repaired with less demanding techniques. As minimally invasive surgery becomes commonplace in hernia surgery, the number of different approaches will continue to grow." - Anonymous Online Contributor

Unverified Answer

What causes hernia?

"It is a problem in women and in Asians\nquestion: Can a low cost method identify all cases of internal hernias? answer: The high rate of missed cases of internal hernia is a major problem for surgical operations using the FAST protocol. Even though we found a statistically insignificant inverse association between FAST and missed hernias, the large number of missing cases (1 of 21) raises concerns regarding its effectiveness. Further research is required to determine whether other screening protocols can outperform the FAST on this particular aspect and whether a combined study of FAST and other protocols should be performed." - Anonymous Online Contributor

Unverified Answer

What is hernia?

"Hernia and hernia procedure are not synonymous. In fact, hernia itself can be seen from medical history alone. Thus, the notion of what hernia is has to be changed in medical studies in order to better translate these articles on hernia and its treatments to a wider general public." - Anonymous Online Contributor

Unverified Answer

Can hernia be cured?

"Many patients with hernia have chronic discomfort. These patients have a low likelihood of their pain alleviation or symptom relief being satisfactory. Most hernia treatments are not successful, and it is possible that many patients do not realize this. The medical history may be the first indication of a possible underlying disorder, which might be the cause of pain." - Anonymous Online Contributor

Unverified Answer

What are the signs of hernia?

"External hernias do not always produce symptomatology, while hernias inside of the abdominal wall are more likely to be symptomatic. The presence of hernia does not always produce symptoms. Thus, the differential diagnosis of hernias can be difficult, particularly when the symptoms are nonspecific." - Anonymous Online Contributor

Unverified Answer

Is anterior gastropexy typically used in combination with any other treatments?

"(1) There is a need for standardisation of the procedure of anterior gastropexy. (2) It is not yet clear whether anterior gastropexy has any effect on the occurrence of other coexisting problems. (3) The need for a randomized control trial and longer follow-up is warranted. (4) We feel that a randomized study comparing the various anterior procedures of hernia repair in terms of their efficacy should be performed. To assess the most cost-effective an anterior resection combining laparoscopic or minimally invasive techniques can be considered." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hernia?

"The median age in this study for inguinal hernia was 38.4. A previous hernia or repair or discomfort is common in early adulthood. In a general surgical practice, most surgeries are done on patients in their 40s or above. An inguinal hernia in a younger patient may require a different approach to repair – typically under general anesthesia." - Anonymous Online Contributor

Unverified Answer

How serious can hernia be?

"A hernia is a serious medical problem and should be treated as such. An isolated strangulation or an incarcerated hernia should be immediately treated if found." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hernia?

"Although it can be safely asserted that any hernia will be caused by the action of some force outside the hernial sac, the relative significance of such factors as intra-abdominal pressure, weight, and abdominal wall weakness, to the hernia, must be clarified. The exact mechanism of herniation is not known. It may be a combination of these factors." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hernia?

"Clinical trials are an important tool in the evaluation of surgical outcomes. They should include the surgeon's role as the operator, the patient's role as the subject and the place of the trial as the site of trial. Clinical trials should assess outcomes such as satisfaction and safety. Clinical trials should have a well-defined protocol, in the form of a PDA, and have defined outcomes. Lastly, patient quality of life evaluations are important. These can include patient satisfaction surveys, a satisfaction questionnaire, a patient global assessment, a physician global assessment, a clinician global assessment, and a hernia patient satisfaction questionnaire." - Anonymous Online Contributor

Unverified Answer

Does hernia run in families?

"Although hernias run in families, the genetic component of hernias may be much less important than previously thought. Hernias occur more often in fathers and sons than in mothers and daughters. It is evident that hernias occur in a higher proportion in families with more than two members in which one of them is affected. However, an interrelationship between an affected individual and his/her family cannot be proven." - Anonymous Online Contributor

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