Active clinical trials for "Incisional Hernia"

Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%). Use of prosthetic mesh in incisional hernia repair lowered the recurrence rates under 10%. Recurrence rate alone is not the main quality criterion for incisional hernia repair anymore. Large series and meta-analyses confirmed the value of laparoscopic repair as at least equal if not better compared with open repair. Discomfort, pain, diminished quality of life and body image alteration influences functional well being. No baseline information exists in any of these fields treating pre- or post-operative phases in patients with incisional hernia. Respiratory functions and medico-economic evaluation are other rarely investigated fields that we consider in our trial. The objective of this study is to analyse the functional outcome status of patients after laparoscopic incisional hernia repair compared to open repair. Methods: A randomized controlled non-blinded clinical trial is designed to compare laparoscopic incisional hernia mesh repair with open repair on post operative pain, health related quality of life outcomes, body image and cosmetic measurements, respiratory functions, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 18 years, with reducible incisional hernia who are candidates for elective surgery and medically fit for general anesthesia.30 patients will be enrolled for each group. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in september 2009.

The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following: Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. Perioperative, short-term and long-term procedural and/or device related complications. Abdominal Wall Function and mobility.

The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently FDA-approved for implantation to reinforce soft tissues where weakness exists, but the investigators would like to collect additional follow-up information to continue to assess the durability of the repair after placement of the hernia mesh. This follow-up would include the collection of information about complications such as infections and seromas (collections of fluid around the surgery site), as well as hernia recurrence and quality of life questionnaires. Patients who qualify to take part in this study have been diagnosed with a ventral incisional hernia and will have been scheduled for a surgical hernia repair. This surgery will be an "open" surgical procedure and reinforcing your tissue with material is indicated for this type of hernia repair.

Prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the Hernia Center of Reference of Gross Sand Hospital using the novel endoscopic assisted Mini- or Less-Open Sublay technique. The data of all patients were prospectively documented in the German Hernia Registry "Herniamed". The novel MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.

The hypothesis of this study is to show that after laparoscopic digestive surgery in obese patients (BMI>30kg/m2), the wearing of an abdominal support belt is an effective treatment for the Incisional Hernia and feasible in terms of compliance, quality of life and patient satisfaction

In the development of surgical technique, laparoscopic surgery has created a major breaking point. Although laparoscopy (decreased hospital stay, decreased incisional hernia and wound infection rate…) provides a remarkable advantage compared to open surgery, the need for the extraction site incision could not bring the incision-related morbidity rates to the desired level. That's why SILS and natural hole surgery came to the fore. Colorectal surgery was also affected by this process, and the laparoscopic colectomy procedure combined with transrectal colon extraction was first performed in 1993 (1). Although its use increased gradually after this period, it could not reach the expected levels and this could not resolve the concerns on natural hole surgery. In this article, our aim is to present the single center results of the patients who performed the extraction with the NOSE method after laparoscopic colorectal surgery.

Urgency surgeries are often performed in a stressful setting with critical patient involved. In this context, laparotomy closure can sometimes be the most neglected part of the procedure. Barbed sutures, frequently used in laparoscopic procedures, have proven to be effective in maintaining traction. The aim of this study is to describe the incisional hernia rate after emergency midline laparotomy, according to the suture utilized, evaluated at one month and one year postoperative.

The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

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

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.