Image-Guided Herniorrhaphy Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 irreducible hernias
Patients with herniation not visible by ultrasound or CT
Trial design
Design model
Single group
Treatments tested in this trial
Image-Guided Herniorrhaphy
Procedure/SurgeryMinimally 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Image-Guided HerniorrhaphyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of the Image-Guided Herniorrhaphy Procedure
Frequency, type, and severity of all procedure-related adverse events, categorized according to the Society of Interventional Radiology (SIR) Adverse Event Classification. Major complications (e.g., bleeding, bowel injury, infection, or events requiring hospitalization \>48 hours) and minor complications will be recorded and reviewed by independent safety monitors.
Time frame
Through 8 months after the procedure2
Change in Hernia-Related Quality of Life (Short Form-36 Health Survey)
Mean change in general health-related quality-of-life scores measured using the Short Form-36 (SF-36) Health Survey, a validated 36-item measure assessing eight domains of physical and mental health. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame
Through 8 months after the procedure3
Change in Hernia-Specific Quality of Life (Hernia-Related Quality-of-Life Survey)
Mean change in hernia-specific quality-of-life scores measured using the Hernia-Related Quality-of-Life Survey (HerQLes), a validated 12-item instrument used for ventral and abdominal wall hernias. Scores range from 0 to 100, with higher scores indicating better hernia-related quality of life.
Time frame
Through 8 months after the procedure4
Change in Reflux-Related Quality of Life (GERD-Health-Related Quality of Life Questionnaire)
Mean change in symptom severity and quality-of-life scores measured using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire, a validated 10-item scale used in patients with hiatal hernias. Scores range from 0 to 75, with higher scores indicating worse reflux symptoms and lower quality of life.
Time frame
Through 8 months after the procedureSecondary outcomes
1
Incidence of Delayed Adhesion-Related Symptoms
Number of participants reporting new or worsening abdominal pain, nausea, vomiting, or bowel obstruction potentially related to intra-abdominal adhesions, assessed via follow-up visits and phone calls.
Time frame
Up to 8 months after procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: