Image-guided Herniorrhaphy Safety and Efficacy Pilot
University of California, Davis
Summary
This pilot clinical study will evaluate the safety and effectiveness of a new image-guided, needle-based approach for repairing abdominal or groin hernias in adults who are unable or unwilling to undergo traditional open or laparoscopic surgery. The technique uses ultrasound and, when needed, CT imaging to guide a hollow needle preloaded with barbed suture through the skin to close the hernia defect without large incisions or general anesthesia. Each participant will undergo one image-guided procedure and will be followed for eight months to assess complications and changes in hernia-related quality of life. Approximately thirty participants will be enrolled. The study aims to determine whether this minimally invasive approach is safe, feasible, and capable of improving hernia symptoms enough to justify a larger clinical trial
Description
Traditional hernia repair requires either open surgical incisions or laparoscopic entry into the abdomen, typically under general anesthesia. Although effective, these operations can be unsuitable for frail or medically complex patients because of anesthesia risks, postoperative pain, and wound complications. This investigator-initiated pilot study explores a minimally invasive alternative: a percutaneous, image-guided herniorrhaphy that uses ultrasound or CT to visualize the hernia and guide placement of a barbed suture through a hollow needle to close the tissue defect. The goal is to asses…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * English-speaking adult with reducible hernia(s) or diastasis smaller than approximately 8 cm seeking treatment for their hernia but not able or willing to undergo traditional surgery (open, laparoscopic, or robotic) * Patient must be willing to undergo a novel 30- to 60-minute image-guided needle-based procedure Exclusion Criteria: * Children, prisoners, and pregnant women (possibly requiring a pregnancy test on the day of the procedure) * Patients with a known reaction to local anesthetic or sedation medications or the suture material to be used * Patients with irredu…
Interventions
- ProcedureImage-Guided Herniorrhaphy
Minimally invasive, image-guided repair of abdominal or groin hernias. Under ultrasound (primary) and, when indicated, low-dose CT guidance, a hollow needle preloaded with bi-directional barbed suture is passed percutaneously across the defect to approximate and secure tissue without surgical incisions or general anesthesia. The procedure is performed in the interventional radiology suite with local anesthesia and optional moderate IV sedation; typical procedure time \~30-60 minutes. Standard post-procedure monitoring is completed prior to discharge. Arm/Intervention Link: Applied to the "Image-Guided Herniorrhaphy" (Experimental) arm.
Location
- UC Davis HealthSacramento, California