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Incisional Hernia clinical trials

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NCT ID: NCT04434573 Completed - Clinical trials for Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias

Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias

Start date: October 2016
Phase:
Study type: Observational

Hernia pathology is one of the leading causes of surgery worldwide. For asymptomatic patients, surgery remains questionable. Although there are new European recommendations, the practice of digestive surgeons regarding the management of asymptomatic hernias is unknown. The objective of this study was to evaluate the practices of a large population of digestive surgeons with asymptomatic hernia.

NCT ID: NCT04430816 Completed - Clinical trials for Hernia Incisional Ventral

Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

comparison between two groups of large midline incisional hernia, the first group managed by double mesh modification of chevrel's technique the second one managed by conventional onlay mesh repair

NCT ID: NCT04417140 Recruiting - Incisional Hernia Clinical Trials

A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis

NO-HERNIA
Start date: May 20, 2020
Phase: Phase 4
Study type: Interventional

Currently, no standard of care exists to prevent incisional hernias (IH). This study will compare how frequently IH develop in standard abdominal closures vs. abdominal closures with dHACM added. By adding dHACM to the standard closure, we think we can reduce the formation of IH. If patients decide to participate in this study, they will be randomly assigned to one of two study arms, Arm A or Arm B. They will have a 50% chance of being assigned to either arm. The assignment will be made by computer program and is completely random. Patients are not informed of which arm they are assigned. Arm A (Treatment Arm): dHACM Patients enrolled in this arm will have a thin sheet of dHACM placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human Amniotic-Chorion Membrane. It is a FDA-registered healing adjunct that has been applied in a broad range of diseases including wounds, plantar fasciitis and burns. Arm B (Control Arm) Patients enrolled in this arm will have standard fascial closure. Data collection will be performed at routine follow-up outpatient clinic visits with the primary surgeon to assess for IH related symptoms. At 6 months after surgery, patients will see a surgeon who is blinded to the randomization. This surgeon will perform a painless handheld ultrasound examination of the incision site.

NCT ID: NCT04410744 Completed - Incisional Hernia Clinical Trials

Incidence and Risk Factors for TSIH

TSIHi
Start date: June 2, 2015
Phase:
Study type: Observational

Trocar site incisional hernia (TSIH) is the most frequent complication associated to laparoscopic surgery. Few studies currently describes its real prevalence or risk factors. The aim of this study is to determine the real incidence of TSIH and to identify risk factors in the investigator's series of patients. A cross sectional, prospective study is performed including consecutive patients who underwent a laparoscopic procedure during a four months period. All the patients are assessed both clinically (TSIHc) and by an ultrasonographic exam (TSIHu). Main variable studied is the incidence of TSIH. A multivariate analysis is performed to identify risk factors.

NCT ID: NCT04394988 Completed - Incisional Hernia Clinical Trials

Total 102 Natural Orifice Specimen Extractions Following Laparoscopic Colorectal Resections

Start date: January 1, 2013
Phase:
Study type: Observational

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.

NCT ID: NCT04358159 Recruiting - Clinical trials for Incisional Hernia of Midline of Abdomen

RCT Ventralex vs Onlay Mesh in Incisional Hernias

VPatchIncRCT
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias

NCT ID: NCT04347642 Recruiting - Incisional Hernia Clinical Trials

Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Start date: July 7, 2020
Phase: Phase 3
Study type: Interventional

The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy. Patients will be randomized into 2 groups: - G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port - G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port. Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.

NCT ID: NCT04312165 Withdrawn - Clinical trials for Suture, Complication

DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery

Start date: May 2023
Phase: N/A
Study type: Interventional

The proposed project aims to evaluate the safety of DuraMesh™ suture for laparotomy closure in an emergent setting, while also providing preliminary efficacy data with regard to incisional hernia prevention. Conventional techniques for laparotomy closure in the setting of an emergency laparotomy or delayed abdominal closure suffer from a lack of durability, with incisional hernia rates of 30-34% reported. While prophylactic planar mesh placement has emerged as a cost-effective strategy to prevent hernia formation in the clean, elective laparotomy setting, higher rates of surgical site complications and increased technical complexity preclude its use in the emergency or contaminated setting. Utilized exactly like conventional suture without any change in surgical closure technique, DuraMesh™ provides the durability of planar mesh reinforcement without the marked increase in foreign material or added surgical complexity. As a result, DuraMesh™ is the only hernia prevention strategy that can be forward-deployed in support of the injured warfighter. While this study is specifically targeted to a gap in the care of the injured warfighter, the potential benefits extend well beyond the military applications. With over 2 million laparotomies performed annually in the United States, and approximately 20% of these resulting in an incisional hernia, the need for an alternative abdominal wall closure strategy is equally dire in the civilian setting. This clinical trial represents an opportunity to drive the needed paradigm shift towards prevention, rather than costly management of incisional hernias. The investigators anticipate this work will rapidly lead to further research, including providing the preliminary data necessary to launch a multi-center randomized controlled trial to assess the clinical efficacy of DuraMesh™ for hernia prevention in both the emergent and elective operative settings.

NCT ID: NCT04311788 Active, not recruiting - Incisional Hernia Clinical Trials

Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial

Start date: April 27, 2020
Phase: N/A
Study type: Interventional

244 patients, who have an emergency midline laparotomy for any gastrointestinal reason, will be randomized in a 1:1 ratio either to mesh group with a retrorectus prophylactic self-gripping mesh or to control group with 4:1 small stitch closure by continuous monofilament suture. They will be followed up at 30 days, 2 and 5 years to detect the incidence of incisional hernia.

NCT ID: NCT04254237 Completed - Incisional Hernia Clinical Trials

Trocar Site Hernia After Laparoscopic Cholecystectomy, Supra Versus Infraumbilical Incision for Umbilical Trocar Entry

HOT
Start date: February 6, 2020
Phase: N/A
Study type: Interventional

Trocar site hernia is a specific complication of laparoscopic surgery. The increasingly frequent use of the laparoscopic approach has resulted in an increase in the number of hernias, mainly at the umbilical area. The appearance of a trocar site hernia can cause complications in the short and long term to the patient who may end up needing a reoperation. In this study we want to compare the supraumbilical versus the infraumbilical location of the laparoscopy entry trocar, in terms of incisional hernia incidence.