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Internal Hernia clinical trials

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NCT ID: NCT05163184 Completed - Clinical trials for Abdominal Wall Hernia

Physiologic Tension of the Abdominal Wall

Start date: January 10, 2022
Phase:
Study type: Observational [Patient Registry]

Restoring the physiologic tension of the abdominal wall is a key concept in abdominal wall reconstruction. Yet little is known quantitatively about the normal tension of the abdominal wall. To better understand the ideal tension for abdominal wall reconstruction, the physiologic tension of the abdominal wall needs to be measured. This study aims to measure the tension of the abdominal wall during laparotomy closure.

NCT ID: NCT05061264 Completed - Infection Clinical Trials

Abdominal Wall Reconstruction With PVDF Mesh in the Setting of Active Infection

Start date: May 2016
Phase: N/A
Study type: Interventional

The use of synthetic mesh to repair infected defects of the abdominal wall remains controversial. This study aimed to evaluate the short-term outcomes of using PVDF mesh to treat infected abdominal wall defects in the elective setting.

NCT ID: NCT04947202 Completed - Ventral Hernia Clinical Trials

Clinical Study on the Safety of SAFIL® MESH

SAFIL_MESH
Start date: July 1, 2021
Phase:
Study type: Observational

Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects

NCT ID: NCT04580511 Recruiting - Clinical trials for Abdominal Wall Defect

Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction

PMCF_AWR
Start date: November 4, 2020
Phase:
Study type: Observational

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material. The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

NCT ID: NCT04578340 Recruiting - Abdominal Hernia Clinical Trials

Long Term Outcomes Following Hernia Repair With Mesh

Start date: October 1, 2020
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

NCT ID: NCT04476212 Recruiting - Clinical trials for Surgical Site Infection

Prophylaxis of Surgical Wound Infection With Topical Antibiotics

Start date: December 27, 2018
Phase: N/A
Study type: Interventional

Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.

NCT ID: NCT04435340 Completed - Abdominal Hernia Clinical Trials

Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

Start date: March 22, 2018
Phase: N/A
Study type: Interventional

Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate

NCT ID: NCT03450473 Completed - Hernia, Ventral Clinical Trials

A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

Large abdominal wall hernias are surgically challenging to repair and often associated with significant postoperative complications. Risk factors associated with surgical site complications, such as infection and wound dehiscence, include obesity, diabetes, and smoking. In these high risk patients, the placement of synthetic mesh increases the risk of mesh infection, enterocutaneous fistula formation, and mesh explantation. One of the larger studies of risk factors associated with mesh explantation demonstrated concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. As an alternative to synthetic meshes, bioprosthetic meshes derived from the decellularization and processing of allogeneic or xenogeneic tissue sources have been introduced that can often allow the surgeon to treat the surgical site occurrences and salvage the repair without required mesh explantation. Low rates of mesh infection and explantation have been reported for bioprosthetic meshes and are recommended in these complicated patients by the Ventral Hernia Working Group, based on the best available clinical evidence. Despite widespread use of bioprosthetic mesh, there continues to be concern for complications associated with their use (i.e. high seroma and recurrence rates, etc.). This has led to the modification of these matrices by several industry leaders (Acelity, Cook, Integra, etc.) to include a fenestrated platform to allow for fluid to flow through the matrix upon implantation while supporting regeneration in complex abdominal wall reconstruction. To our knowledge, there are no clinical studies prospectively evaluating the long term clinical outcomes for abdominal wall reconstruction procedures involving fenestrated macropourous biologic matrices.This macroporous technology allows for tissue revascularization and integration of the biologic graft and thus an expected improvement in overall outcome. Bioprosthetic fenestrated materials such as Surgimend MP® were developed to assist with earlier incorporation and vascularization of the biologic graft while providing reinforcement of hernia repair. However, there is an absence of high quality prospective data regarding the use of these materials in complicated abdominal wall reconstruction, and no comparative data exists. This study is a prospective, case series study evaluating the efficacy and performance of SurgiMend MP® during complex ventral hernia repairs. This case series involves a biologically derived hernia mesh under its cleared FDA indication for hernia repair. Efficacy will be determined by quantifying surgical complications, hernia recurrence, and cost effectiveness endpoints.

NCT ID: NCT03434301 Completed - Incisional Hernia Clinical Trials

Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTackā„¢ v ProTackā„¢

TACKoMesh
Start date: July 20, 2017
Phase: N/A
Study type: Interventional

This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable material. Both fixation devices are commonly used but two questions remain unanswered, does one cause more chronic pain and also what if any will be the effect on recurrence rates of the hernia. No trial has been undertaken to date which will not only examine the fixation device but in the setting where the hernia is closed first. The closure of the hernial defect by the keyhole technique is a relatively new and growing concept in the hernia world.

NCT ID: NCT03310905 Recruiting - Clinical trials for Transplant;Failure,Kidney

Abdominal Wall Transplant

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.