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Incisional Hernia clinical trials

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NCT ID: NCT05599750 Recruiting - Incisional Hernia Clinical Trials

Suture Repair vs Mesh Repair for Incisional Hernia

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. The main question it aims to answer are: • Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.

NCT ID: NCT05596357 Recruiting - Incisional Hernia Clinical Trials

Incisional heRnia dIgestion Sexuality

IRIS
Start date: July 10, 2023
Phase:
Study type: Observational

After an operation on the abdomen, some patients present with an incisional hernia(incisional hernia) which causes a permanent exteriorization of the vicera. This situation is at the origin of postural problems. Surgery which consists both of reducing pain and correcting the functional limitation and aesthetic damage helps restore normal anatomy and improve muscle tension of the wall, restore the musculoskeletal balance of the trunk and thus the cardio-respiratory and motor functions of patients. The resulting benefits on quality of life and reduction of chronic pain have been demonstrated by several studies. This study tends to better understand the functional and sexual prejudices linked to these parietal pathologies by passing questionnaires to the operated patients

NCT ID: NCT05579652 Completed - Incisional Hernia Clinical Trials

Change in Fascial Tension in Open Abdomens

Start date: October 17, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.

NCT ID: NCT05576753 Recruiting - Ventral Hernia Clinical Trials

Preperitoneal Umbilical Mesh Area

PUMA
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to measure the mesh shrinkage and the visualization of the mesh with MRI scan at 1 month and 13 months after robot assisted preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).

NCT ID: NCT05575141 Not yet recruiting - Clinical trials for Ventral Incisional Hernia

Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias

ROCSTAR
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.

NCT ID: NCT05568238 Not yet recruiting - Incisional Hernia Clinical Trials

Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen

VAWCPOM
Start date: October 2022
Phase: N/A
Study type: Interventional

Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed. Hypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates. Aims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique. Design A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.

NCT ID: NCT05528692 Suspended - Incisional Hernia Clinical Trials

The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients

MAGELA
Start date: February 2024
Phase:
Study type: Observational

The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans.

NCT ID: NCT05528107 Recruiting - Clinical trials for Incisional Hernia of Midline of Abdomen

Laparoscopic IPOM Plus vs. eTEP Trial

Start date: February 14, 2023
Phase: N/A
Study type: Interventional

The survey will compare primary and secondary outcomes of laparoscopic intraperitoneal onlay mesh (IPOM plus) and extended totally extraperitoneal (eTEP) repair for incisional hernia. The research hypothesis is the following: patients who underwent eTEP repair may experience 30% less pain, assessed on the NRS-11 scale by the end of postoperative day 1, compared with IPOM plus procedure

NCT ID: NCT05509452 Not yet recruiting - Incisional Hernia Clinical Trials

Risk Factors of Incisional Hernias After Emergency Midline Laparotomy

INCISE
Start date: February 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.

NCT ID: NCT05508152 Completed - Clinical trials for Postoperative Hernia

Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR)

(PROTOP-PAR)
Start date: February 1, 2021
Phase: Phase 3
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 incisional hernia repair after abdominal surgery. Method. Randomized double-blind clinical trial comparing two groups of topical prophylaxis. Follow-up will be 90 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.