Ultrapro mesh for Hernia

Phase-Based Estimates
2
Effectiveness
3
Safety
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, NY
Hernia+1 More
Ultrapro mesh - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Hernia

Study Summary

This study is evaluating whether a mesh can be used to help prevent bladder leakage after surgery.

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Eligible Conditions

  • Hernia
  • Radical Cystectomy

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Ultrapro mesh will improve 1 primary outcome in patients with Hernia. Measurement will happen over the course of within 2 years of RC and IC..

Year 2
Number of patients with incidence of radiographic Parastomal Hernia

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Surgery (Usual approach group)
Surgery + Mesh Placement

This trial requires 178 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ultrapro Mesh is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Surgery + Mesh Placementprophylactic mesh at the time of standard surgery
Surgery (Usual approach group)
Procedure
standard surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrapro mesh
2011
N/A
~150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 2 years of rc and ic.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 2 years of rc and ic. for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York, NY

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Patients undergoing RC and IC formation in an elective setting,for cancer.

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 causes hernia?

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Hernia can be caused by a congenital defect, injury during an operation, or by aging. A rare form of a congenital defect called Moberg's disease is characterized by hernias in the abdominal area because of the weakness of the abdominal wall muscle. The diagnosis of hernia can be made by considering all the causes.

Unverified Answer

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

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Hernias affect a large number of Americans each year, and this number will probably increase in time. By 2025, some 3.3 million hernias annually will be seen in ambulatory surgical practices. The yearly rate of hernias can be predicted with only a limited degree of accuracy based on age and gender, but the rate of hernias among infants, adolescents, and older adults can not.

Unverified Answer

Can hernia be cured?

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Given the high rate of comorbidity and recurrence found in the initial trial, we believe that repair appears better than no repair. More work would be needed to demonstrate this effect as a strategy to prevent hernia recurrence in this frail population.

Unverified Answer

What are the signs of hernia?

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In women, the most common and well defined hernia disease is a painful condition of the groin called an "inguinal hernia". In men, the most common and best understood condition is also of the groin, an "inguinal hernia", but this disease is often incorrectly called "varicocele".

Unverified Answer

What is hernia?

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A hernia is any abnormal opening in the wall of the abdominal cavity. More than 75% of all hernias occur in the abdominal wall and groin (internal inguinal ring). Tenderness in the abdominal wall and groin is the major symptom as the hernia affects mobility. It occurs more commonly in women of advancing age and occurs frequently in pregnancy. Lumbar hernia of the rectus sheath is the most common hernia. Hernias may be painful, while a small hernia in the left lower quadrant may be asymptomatic. A general practice should be familiar with this and the symptoms. Imaging is essential to localize the hernias to the correct area.

Unverified Answer

What are common treatments for hernia?

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Some cases of hernia are difficult to solve because of the wide range of clinical and surgical considerations. To be specific, the choice of method used to alleviate the complaints of patients with groin, femoral, or supra-trochanteric hernias needs special attention (surgery is the first choice for most cases, as it is the most economical and effective remedy). A detailed treatment manual can prove useful.

Unverified Answer

What is the average age someone gets hernia?

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The average age to get a hernia during my time of practice is 56.7 years old. We used to know what age someone would get a hernia but due to insurance cost issues now we need a way to know how long someone would stay with a hernia after receiving medical treatment.\n

Unverified Answer

Is ultrapro mesh safe for people?

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Recent findings shows that the ultrapro material studied is generally safe for primary abdominal wall closure in patients with hernias. The material itself does not appear to increase the risk of recurrence or hernia development following the repair of primary hernia repair.

Unverified Answer

How serious can hernia be?

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Results from a recent clinical trial show that the symptoms experienced by patients with hernias are related to the nature of the hernia. The nature of the hernia dictates the severity of pain it causes. A sliding hernia results in greater pain than a hernia that occupies the lower abdomen. In addition, in this study, patients with a strangulating hernia were found to experience more pain than a hernia of other nature. Therefore, an urgent diagnosis and treatment is required. In this article we have provided a table stating the severity in regard to hernia. This table aids in assessing the severity of hernia. The table is divided into two parts. The first part illustrates the severity of the hernia in relation to its size.

Unverified Answer

Does ultrapro mesh improve quality of life for those with hernia?

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Ultrapro mesh is safe, and has a better physical quality of life in patients with hernia compared to conventional (polypropylene) mesh. It could be an option for those with advanced comorbidities. Longer-term follow up will be required to assess the long-term physical quality of life.

Unverified Answer

Is ultrapro mesh typically used in combination with any other treatments?

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A prospective multicenter randomized trial in two different countries could not replicate previous results related to the combined use of the Ultrapro mesh and mesh repairs. The UltraPro mesh is no more effective than mesh repairs alone. A prospective multicenter randomized trial in two different countries could not replicate previous results related to the combined use of the UltraPro mesh and mesh repairs. The UltraPro mesh is no more effective than mesh repairs alone.

Unverified Answer

What is ultrapro mesh?

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There needs to be a need to communicate what this product is all about. The information on the label should clearly define the product, its potential risks and what it is not or what it is supposed to be. Inappropriate information should be removed in accordance with FDA guidelines.

Unverified Answer
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