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Incisional Hernia clinical trials

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NCT ID: NCT05050786 Not yet recruiting - Quality of Life Clinical Trials

Prophylactic Negative Pressure Wound Therapy for Patients Undergoing Incisional Hernia Repair

PROPRESS
Start date: January 2022
Phase: N/A
Study type: Interventional

The study will examine the effect of using Negative Pressure Wound Therapy (NPWT) compared with standard wound dressing among patients undergoing elective open surgery for incisional hernia. The study's main hypothesis is that NPWT will decrease the post-operative incidence of surgical site infections and also improve the patients' quality of life including less scar-related pain and higher cosmetic satisfaction.

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: 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: 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: NCT04624100 Not yet recruiting - Clinical trials for Ventral Incisional Hernia

Quality Control of Ventral Hernia Surgery by Prospective Registration

Start date: July 1, 2024
Phase:
Study type: Observational [Patient Registry]

Quality Control of ventral hernia surgery in 21 Belgian hospitals by prospective registration in close collaboration with the Danish Hernia Database.

NCT ID: NCT04538768 Not yet recruiting - Clinical trials for Incisional LLQ Hernia

Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh

Start date: October 2020
Phase: N/A
Study type: Interventional

The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.

NCT ID: NCT04512469 Not yet recruiting - Clinical trials for Incisional Hernia of Anterior Abdominal Wall

Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients

Start date: September 2020
Phase: N/A
Study type: Interventional

Study Design: Single-blinded, randomized, prospective clinical trial. Study Population: End-stage liver disease patients' candidates for liver transplantation. Study procedures: Consenting patients will be divided into two matched groups: 1. CONTROL group - receiving a standard running fascial closure with PDS suture 2. TREATMENT group - receiving a standard running fascial closure with PDS suture PLUS a low molecular weight mesh. The mesh will be secured to the fascia extending 3 cm from the incisional site. There will be no modifications to routine post-operative wound care in both groups. However, the treatment group will have an additional drain placed at the incision site compared to the control group to reduce the risk of a seroma from placement of the mesh. Wound dressing will be removed on post-op day 2 and the wound will be assessed. Re-application of the dressing will occur thereafter until proper healing of the incision. An abdominal ultrasound will be done on all study participants at the 1- and 2-year mark postoperatively to look for objective evidence of a ventral incisional hernia. A CT scan will be performed if the abdominal ultrasound findings are inconclusive.

NCT ID: NCT03953365 Not yet recruiting - Incisional Hernia Clinical Trials

Prophylactic Mesh in Cytoreductive Surgery

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

NCT ID: NCT03750942 Not yet recruiting - Incisional Hernia Clinical Trials

PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial

PROMISS
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Rationale: Approximately 7000 stomata are created in the Netherlands every year. The occurrence of a parastomal herniation is high, with a reported incidence of 4-48%. Also, the former stoma site is at increased risk for the development of an incisional hernia. A clinical incisional hernia rate of 30% is reported after stoma reversal. Herniation can cause pain, deformity and possibly incarceration, which results in a significant impact on the quality of life of the patient. The hypothesis of this study is that the use of a prophylactic mesh at the time of stoma formation leads to a lower incidence of incisional hernias after stoma reversal, an improved quality of life and therefore a possible cost reduction in healthcare. Objective: To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh placement compared to no mesh placement. In addition, we aim to assess the effect of preventive mesh placement on the quality of life and the effect on healthcare cost reduction by avoiding re-intervention. Study design: A multicentre double blind randomized controlled trial with a total follow up of 24 months. Study population: Adults (18-99) undergoing bowel resection with the formation of a temporary stoma. Intervention: A preventive mesh will be placed using a sublay keyhole technique (pre-peritoneal, retromuscular) at stoma formation. The mesh will be left in situ after stoma reversal and the hole in the mesh will be closed, to prevent incisional herniation. Main study parameters/endpoints: - Primary: Incidence of incisional hernias after stoma reversal - Secondary: Quality of life, stoma related prolapse or parastomal herniation, cost effectiveness and mesh related complications. Nature and extent of the burden and the risks associated with participation, benefit and group relatedness: The standard surgical procedure for the treatment of parastomal hernias is used in a prophylactic fashion. As this is standard care in parastomal hernias the risks are minimal. The mesh that is used is CE approved. The burden of participation in this study is minimal for the patient all follow-up visits coincide with the regular visits for colorectal cancer. Hence, no extra outpatient department visits, and even no additional diagnostics nor other medical procedures that could potentially burden the patient, are required.

NCT ID: NCT02896686 Not yet recruiting - Incisional Hernia Clinical Trials

Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure

ILEOMESH
Start date: October 2016
Phase: Phase 4
Study type: Interventional

The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer