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Incisional Hernia clinical trials

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NCT ID: NCT06251583 Recruiting - Wound Infection Clinical Trials

Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.

INDURATE
Start date: March 22, 2023
Phase: Phase 3
Study type: Interventional

Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs. The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias. INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.

NCT ID: NCT06220058 Recruiting - Colorectal Cancer Clinical Trials

Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.

BITEME
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.

NCT ID: NCT06220045 Recruiting - Colorectal Cancer Clinical Trials

Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.

PROFIMESH
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard. Current literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain. It is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.

NCT ID: NCT06066385 Recruiting - Pain Clinical Trials

Suture Techniques to Reduce the Incidence of Incisional Hernia: LTFU STITCH Trial

LTFU-STITCH
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Rationale: Incisional hernias (IH) are a frequent complication after abdominal surgery. Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70% in high-risk patients after open surgery. To investigate different fascia closure techniques in the prevention of IHs, the STITCH trial (NCT01132209) was designed. The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy. Patients were randomly assigned to the intervention group (small bites 5 mm x 5 mm) or the control group (large bites 1 cm x 1 cm). The study showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision. So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group. Objective: The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.

NCT ID: NCT06063577 Recruiting - Clinical trials for C.Surgical Procedure; Disruption of Wound, Suture

Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

STRATA-G
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

NCT ID: NCT06016426 Recruiting - Incisional Hernia Clinical Trials

Mass Closure vs Layer by Layer Closure

Start date: September 30, 2023
Phase: N/A
Study type: Interventional

to assess two different ways of closure of laparotomy in children and infants

NCT ID: NCT05939687 Recruiting - Surgery Clinical Trials

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

ProMeLAR
Start date: June 5, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study. Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.

NCT ID: NCT05734222 Recruiting - Incisional Hernia Clinical Trials

Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias

Start date: September 29, 2022
Phase: N/A
Study type: Interventional

The goal of our work of optimization of the treatment of postoperative hernias is to improve the results of treatment of patients with median and median-lateral postoperative hernias of medium (W2) and large (W3) sizes by developing new surgical techniques. The main questions it aims to answer are: 1. To study the topographic and variant anatomy of vessels and nerves in the retromuscular, preperitoneal, postperitoneal and pre-abdominal cell spaces of the anterior abdominal wall. To determine the most probable sources of blood flow and lymph from the anatomical formations forming the bed of the endoprosthesis. 2. To develop technical, surgical techniques that allow to form an implant bed with minimal traumatization of blood vessels and nerves and reduce the risk of postoperative complications. 3. To develop a technique for plasty of the anterior abdominal wall in mid-lateral postoperative hernias with a combination of retromuscular and subaponeurotic spaces. The researchers will compare an experimental group in which a new method of preparing the implant place will be used and a control group in which standard methods of treating postoperative ventral hernias were used to see whether the new method affects the improvement of the postoperative period and the reduction of complications.

NCT ID: NCT05718999 Recruiting - Incisional Hernia Clinical Trials

XGBoost for Predict Incisional Hernia

XGB&IncHern
Start date: January 30, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to develop a predictive model of IH based on machine learning with the use of the XGBoost technique, this will help surgeons in charge of abdominal wall closure to have objective support to determine high-risk patients and in them modify the closure technique or use a mesh according to their choice or the degree of contamination of the abdominal cavity.

NCT ID: NCT05695157 Recruiting - Wound Infection Clinical Trials

Clinical Performance and Safety of Suture-TOOL

Start date: January 10, 2023
Phase: N/A
Study type: Interventional

The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery. The study population consists of 38 patients selected for open abdominal procedures for malignant and benign colorectal disease. The main question it aims to answer is: • If the device facilitates a Suture-Length to Wound-Length (SL/WL) ratio of 4:1 Participants laparotomy wound will be closed with the device at the end of the operation and closure related data as closure time and SL/WL ratio will be calculated. The wound will be assessed for infection during the postoperative stay and the chart will be reviewed for wound dehiscence and wound infection.