Ongoing Clinical Trials for Incisional Hernia
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for incisional hernia. This trial is exploring the use of botulinum toxin A injections to improve surgical outcomes for patients undergoing hernia repair. The trial is taking place in France and aims to determine whether muscle relaxation before surgery can reduce complications and improve recovery.
Clinical trial locations
Study on Botulinum Toxin A Injection for Patients with Large Incisional Hernia
This clinical trial is investigating whether injecting botulinum toxin A into the abdominal wall muscles before surgery can improve outcomes for patients with large incisional hernias. An incisional hernia occurs when tissue pushes through a weak spot in the abdominal wall, typically at the site of a previous surgical incision. This condition can cause a noticeable bulge, discomfort, and potentially serious complications if left untreated.
Main inclusion criteria: Patients eligible for this study must be between 18 and 79 years old with a body mass index below 35 kg/m². They should have a midline incisional hernia that is at least 10 cm wide, confirmed by a CT scan performed within the last 6 months. The hernia must not occupy more than 25% of the abdominal cavity. Participants need to be scheduled for open surgical repair and must provide written informed consent. Women of childbearing potential must use highly effective birth control methods throughout the study.
Main exclusion criteria: The trial excludes patients who are under 18 or over 65 years old, those who are pregnant or breastfeeding, and individuals with a history of severe allergic reactions. Patients with uncontrolled medical conditions such as high blood pressure or diabetes, those who have undergone major surgery in the past 3 months, or individuals with a history of drug or alcohol abuse in the past year cannot participate. Additionally, patients currently enrolled in another clinical trial, those with known infections or active cancer, and individuals unable to follow study procedures or attend follow-up visits are not eligible.
Focus and goal: The primary aim of this study is to determine whether botulinum toxin A injections can reduce the rate of complications following surgical repair of large incisional hernias. The trial uses a double-blind design, meaning neither participants nor researchers know who receives the actual treatment (XEOMIN, a form of botulinum toxin A) or a placebo. Participants will be monitored closely during the 90 days following surgery for any complications classified as grade II or higher according to the Clavien-Dindo classification system. The study will also track hospital stay length, pain levels, hernia recurrence, and quality of life at various time points up to one year after surgery.
Investigational drug: The treatment being tested is botulinum toxin A, specifically the product XEOMIN. This medication works by blocking the release of acetylcholine, a neurotransmitter that signals muscles to contract, resulting in muscle relaxation. The injection is administered into the lateral abdominal wall muscles before surgery with the goal of making the surgical repair easier and potentially improving recovery outcomes. By relaxing these muscles preoperatively, researchers hope to reduce tension on the surgical site and decrease the likelihood of postoperative complications.
Summary
Currently, only one clinical trial is actively recruiting patients with incisional hernia. This trial is taking place in France and represents an innovative approach to improving surgical outcomes through preoperative muscle relaxation. The focus on botulinum toxin A injections reflects growing interest in optimizing the surgical environment before hernia repair to reduce complications and enhance recovery. Patients interested in this trial should discuss eligibility with their healthcare provider, particularly regarding the age, hernia size, and general health requirements outlined in the study criteria.
