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Incisional Hernia clinical trials

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NCT ID: NCT04801394 Completed - Incisional Hernia Clinical Trials

Retrospective Analysis on Large Incisional Hernia in High Risk Patients

Start date: April 1, 2010
Phase: N/A
Study type: Interventional

Large incisional hernia (LIH) is a challenging condition where the abdominal wall is hopelessly compromised. Nowadays the best treatment option in this particularly frail subset of patients is a major issue. The Auhtors proposed the clinical experience with an innovative approach with the composite Free Lateral Polypropylene prosthesis (FLaPp®) mesh fashioned as "neoperitoneum" analyzing its feasibility and short/medium term results.

NCT ID: NCT04794582 Recruiting - Clinical trials for Postoperative Complications

Prevention of Incisional Hernia After Renal Transplantation

Start date: August 31, 2022
Phase: N/A
Study type: Interventional

Randomized clinical trial to determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by reduction in the incidence of incisional hernia at 2 years post-transplantation.

NCT ID: NCT04788875 Not yet recruiting - Incisional Hernia Clinical Trials

Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies.

SBT-CML
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

In the attempt to gain quick and complete access to the abdominal regions with the least damage to the nerves and the vascular structures, surgeons use the median laparotomy more frequently. However, postoperative complications such as incisional hernia continue to be the known leading complications after median laparotomy. The reported cases to range from 2 to 20%. Higher cases have also been reported with up to 35% in the absence and aortic patients. Recent statistics have showed that small tissue bites prevent incisional hernia can occur in the aponeurosis. This technique is more effective than the commonly used process, which involves large edges of mass closure. In this study investigators aim to compare small bites sutures in closure of laparotomy incision and standardized large bites sutures, and its affect in reducing the incidence of incisional hernia postoperative along with the surgical site infection. the investigators hypothesize that the small bites technique will result in a significant reduction of the incidence of incisional hernia and optimize the surgical site infection in major surgeries which may lead to a reduced morbidity and a better quality of life for patients and a significant reduction of costs.

NCT ID: NCT04718168 Recruiting - Incisional Hernia Clinical Trials

GORE® ENFORM Biomaterial Product Study

ENF 18-06
Start date: May 17, 2021
Phase: N/A
Study type: Interventional

A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance.

NCT ID: NCT04700956 Completed - Incisional Hernia Clinical Trials

Does the Use of Prophylactic Mesh Reduce Incisional Hernia?

Start date: December 19, 2020
Phase: N/A
Study type: Interventional

Incisional hernia is a common condition after abdominal surgery. Because linea alba has less vascularity, incisional hernia more common in midline incisions. It is seen in the general population between 11-20%. In some high-risk situations, this rate increases up to 40-69% (abdominal aortic aneurysm, morbid obesity, colorectal surgery).It is known that incisional hernia that occurs in the postoperative period can lead to emergency surgical causes such as incarceration-strangulation, has a significant share in health expenses and seriously impairs the quality of life in patients.One of the methods tried to reduce incisional hernia is the use of mesh. But this abdominal closure technique is not used routinely in our country and the other countries. This study will be important of the studies in Turkey and world for patient selection in prophylactic mesh use, techniques to be applied and early / late results. The aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy.

NCT ID: NCT04699201 Recruiting - Incisional Hernia Clinical Trials

Trocar Site Incisional Hernia Prevention

PHIT
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery. Methods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months. An ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination. Relevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique. There are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.

NCT ID: NCT04690179 Not yet recruiting - Sarcopenia Clinical Trials

Effects of Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery

Start date: January 18, 2021
Phase:
Study type: Observational

The objective of our study is to evaluate the prevalence of sarcopenia and sarcopenic obesity in our surgical population and their relationship in postoperative complications after complex abdominal wall surgery and its influence on hernia recurrence. This is a retrospective study on a prospective maintains database of complex abdominal wall surgery. We select patients with defects larger than 10 cm from any location (W3 of the EHS classification), excluding other causes of complex abdominal wall in order to have a more homogeneous sample. Pre-surgical computed tomography (CT) scans of the selected patients will be reviewed to establish the diagnosis of sarcopenia, obesity, sarcopenia-obesity or the absence of these (normal). The CT scans will be reviewed by two trained investigators, blinded to postoperative complications and survival. In case of disagreement, a third investigator will break the tie. The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index. Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra (L3). The BMI, the Visceral Fat Area and the Subcutaneous Fat Area (SFA) will also be measured. With the previous data, the VFA / SFA ratio will be calculated. The study will be completed with the collection of sociodemographic data, comorbidities and presence of risk factors for the development of incisional hernia, ASA, size and location of the hernia, surgical technique, postoperative complications according to Clavien-Dindo, stay, readmission, late complications and hernia recurrence. Likewise, the presence or absence of recurrence will be collected. Statistical analysis will be performed to see if there is a correlation between sarcopenia and sarcopenic obesity with the appearance of local and systemic complications and recurrence. To evaluate the independent contribution of each variable to the presence of complications, a univariate and multivariate logistic regression analysis will be performed.

NCT ID: NCT04681326 Recruiting - Incisional Hernia Clinical Trials

Prophylactic Implantation of Biologic Mesh in Peritonitis

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis the risk of incisional hernia (IH) is extremely elevated. The incidence of IH in patients operated with peritonitis is up to 54 %, compared with an incidence of 11-26 % in the general surgical population. Moreover, up to 24.1 % of patients with peritonitis undergoing emergency laparotomy may develop fascial dehiscence. The evaluation of quality of life of patients with IH showed lower mean scores on physical components of health-related quality of life and body image. The prophylactic mesh implantation demonstrated to reduce the incisional hernia rate in patients undergoing vascular or bariatric procedures. However, the intraperitoneal non absorbable mesh implantation in infected fields is generally considered at least of doubtful safety because of the theoretical increased risk of chronic mesh infection and enterocutaneous fistula. Most incisional hernias develop during the first three months after surgery, which represents the critical period for the healing of transected muscular and fibrous layers of the abdominal wall. However, most studies recommended a long-term follow up period of up to at least 5 years for midline abdominal incisions to determine the real incisional hernia rate. The midline abdominal incision is preferred in abdominal surgery, as it provides wide and rapid access compared other incisions. However, the incidence of incisional hernias is higher following midline abdominal incisions than in other abdominal incisions. In emergency surgery the midline incision in the majority of cases is a necessity. Several factors affect the process of wound healing: surgical site infection, poor surgical technique, and patient-related factors (i.e. peritonitis, old age, obesity, diabetes mellitus, nutritional deficiencies, hepatic cirrhosis, jaundice, renal impairment, malignancy, cardiac disease, chest problems, previous abdominal incisions, steroid therapy). Data about the use of biological prosthesis in infected fields are scarce and derive principally from case reports and case series. However, indications about their use and usefulness in infected fields have been recently published by the Italian Biological Prosthesis Working Group (IBPWG). A previously published prospective observational study evaluated the efficacy of implantation of biological prosthesis in high risk patients in order to reduce the incidence of incisional hernia. This study suggested the efficacy of this kind of prosthesis in reducing incisional hernia rate in patients with multiple risk factors. A recently published meta-analysis showed as the use of biological prosthesis in ventral hernia repair resulted in a lower infectious wound complication rate but in an similar recurrence rate. These results supports the application of biological prosthesis in high risk patients. One recent systematic review evaluated the positive effect on incisional hernia rate of the prophylactic mesh positioning in high risk patients. No randomized trials have been published since now about the use of biological prosthesis in contaminated or infected fields. The rationale of the trial is to evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.

NCT ID: NCT04643197 Not yet recruiting - Gynecologic Disease Clinical Trials

Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)

BARBHER
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.

NCT ID: NCT04626336 Active, not recruiting - Hernia Clinical Trials

Post-operative Hernias After Radical Cystectomy

Start date: January 30, 2010
Phase:
Study type: Observational

Post-operative hernias after cystectomy are frequent (our review of the literature with meta-analysis found an incidence of evisceration at 5%, median eventrations at 8% and peristomal hernias at 14%). These represent a non-negligible and partially morbidity. avoidable, subject to proper assessment of personal and surgical risk factors