CompletedNot Applicable

Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device

Israel, Slovenia29 participantsStarted 2020-02-23

Plain-language summary

Intended Use The Su2ura™ Approximation Device is indicated for tissue approximation in endoscopic and open surgery for the placement of interrupted or running stitches in soft tissue such as hernia repair Objectives To assess the safety and efficacy of the Su2ura approximation device for the laparoscopic repair of primary umbilical hernia Number of Subjects 45 patients Number of Centers Two study centers in Israel and one in Slovenia. Study Duration 6 months Study Procedures Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered at induction of anesthesia. A single surgeon, the PI, will perform the procedure. A surgical assistant will be selected by the PI from the surgical staff of the department. The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura approximation device and fixation of mesh with tacks over the closed defect. Study follow up visits: at post operation discharge, 14 days, 3 months, 6 months. Study follow up procedures: Also include SAE's and SADE's during follow up 1. Quality of life questionnaire: patient-reported satisfaction and function will be assessed through the validated, hernia-specific European Hernia Society Quality of Life questionnaire (EuraHS-QoL) 2. Clinical testing to determine hernia recurrence and clinical bulging Statistical analysis The sample size calculation based on the Exact Binomial distribution. The investigators will compute the 95% confidence intervals for a binomial probability, relying on the Clopper-Pearson (exact) method.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * Patient desires elective surgical repair * Patient is able to give informed consent * Diagnosis of a primary umbilical hernia with a fascial defect of width no more than 5 cm in size on clinical examination or CT scan * Body mass index (BMI) 20-40 kg/m2 * Candidate for laparoscopic repair based on the operating surgeon's assessment Exclusion Criteria: * Non-primary or incisional hernia in the umbilical hernia * Diagnosis of concomitant abdominal wall defect(s) contiguous with primary umbilical hernia * Patient previously underwent open or laparoscopic umbilical hernia repair surgery * Patient previously underwent open or laparoscopic abdominal surgery which spans the umbilical area * Patient in need of concomitant non-hernia repair surgical procedure(s) * Patient in need of emergent primary umbilical hernia repair for complications such as incarceration, intestinal obstruction or strangulation * The patient desires hernia repair using a technique other than that consistent with the study * Patient has loss of domain as assessed on physical examination or CT scan * Patient has a severe co-morbid condition likely to limit survival to less than 2 years * Patient was treated with chemotherapy in the past 6 months * Patient was treated with steroids in the past 6 months * Pre-operative or intra-operative contamination of the surgical site * Patient with known collagen disorder * Patient is pregnant or intends to become pregnant during the s…

What they're measuring

Overall rate of Serious Adverse Events and serious adverse device effects (SADE) up to hospital discharge and up to the 60th post-operative day.

Timeframe: 60 days from baseline

Trial details

NCT IDNCT04393532

SponsorAnchora Medical

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-28