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Internal Hernia clinical trials

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NCT ID: NCT06111287 Completed - Hernia, Abdominal Clinical Trials

Outcomes of Trasversus Abdominis Release for Complex Abdominal Wall Hernia

IMPACT
Start date: January 2015
Phase:
Study type: Observational

This multicenter retrospective study analyzed data from 308 patients who underwent open Posterior Component separation with Trasversus release for primary or recurrent complex abdominal hernias between 2015 and 2020. The primary endpoint was the rate of Hernia Recurrence and Mesh Bulging at 3, 6, 12, 24, and 36 months. Secondary outcomes included surgical site events and were assessed using the Pain scale.

NCT ID: NCT06034652 Completed - Hernia Clinical Trials

T-GENVIH-003 LTFU (Long Term Follow Up) Study

Start date: September 12, 2023
Phase:
Study type: Observational

The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.

NCT ID: NCT05972707 Completed - Clinical trials for Abdominal Wall Hernia

Magnitude, Types, and Associated Factors of External Abdominal Hernias Among Adult Patients Visiting the Surgical Outpatient Department at Hiwotfana Comprehensive Specialized Hospital and Jugol Regional Hospital, Eastern Ethiopia: A Cross-Sectional Study

Start date: October 20, 2022
Phase:
Study type: Observational

The study was aimed at determining the magnitude, types, and associated factors of external abdominal hernia among adult patients visiting the outpatient department at the Hiwot Fana Comprehensive Specialized Hospital (HFCSH) and Jugol regional hospital in eastern Ethiopia.

NCT ID: NCT05205213 Completed - Incisional Hernia Clinical Trials

Stepwise for the Treatment of Lateral Incisional Hernias

Start date: February 6, 2012
Phase:
Study type: Observational

The best approach for lateral incisional hernia is not known. Posterior component separation (reverse TAR) offers the possibility of using the retromuscular space for medial extension of the challenging preperitoneal plane. The main objective of the study was to describe the surgical techniques used and their outcomes in the open lateral approach for the treatment of L3-L4 European Hernia Society (EHS) classification Incisional hernias, comparing the results between reverse TAR and pure lateral retromuscular preperitoneal, and analyzing the short- and long- term complications, including patient-reported outcomes measures (PROMs). The study report followed the recommendations for reporting outcomes in abdominal wall hernias, and the new international classification of abdominal wall planes (ICAP). A multicenter retrospective observational study was conducted using a prospectively maintained database from three university hospitals in Spain specialized in complex abdominal wall reconstruction. All patients undergoing open abdominal wall repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020 were identified. All patients were operated on by the senior surgeons responsible for the complex abdominal wall units of each participating center. Prior to conducting the study, the approval of the local ethics committee was obtained (ID:39/2019). Written informed consent was also obtained. The diagnosis of IH was based on clinical examination and imaging from a computed tomography (CT). The investigator only included patients with L3-L4 IHs. Patients with primary lateral hernias, such as Spiegel, Grynfelt and Petit hernias were excluded. We also excluded all patients in which the lateral IH was a parastomal hernia. Demographic data, patient comorbidities, different classifications of hernia complexity, Carolinas Equation for Determining Associated Risks (CeDAR) and intraoperative and postoperative data were collected All patients followed a similar preoperative optimization program, which included endocrinologic and nutritional evaluations, respiratory physiotherapy, and abstinence from smoking at least 1 month before surgery. Weight loss was extremely recommended but without any mandatory prerequisite.

NCT ID: NCT05195957 Completed - Clinical trials for Abdominal Wall Hernia

Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair

EUROTAR
Start date: January 17, 2021
Phase:
Study type: Observational [Patient Registry]

This is a retrospective European multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rTAR) or open transversus abdominis release (oTAR).

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: 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.