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

NCT04393532 | Completed

• 1 other identifier: ANC-001
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 3

Brief 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. 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. 2.Clinical testing to determine hernia recurrence and clinical bulging

Conditions

Primary Umbilical Hernia

Keywords

hernia; umbilical; repair; primary; laparoscopic

Outcome Measures

Primary Outcomes (1)

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

  AEs and SADEs will be documented and reviewed to assess the safety of the device

  60 days from baseline

Secondary Outcomes (4)

• Hernia Recurrence Rate at 6 months (Investigator confirmed hernia recurrence on physical examination)

  6 months

• Patient satisfaction and function as assessed by the European Hernia Society quality of life questionnaire (EuraHS-QoL) at a 6-month follow up. Score range : 0-180, lower score indicates less pain and discomfort.

  6 months

• Clinical bulging defined as any bulge of tissue or mesh beyond the natural contour of the abdomen on supine flexion at 6 months follow up.

  6 months

• Evidence of seroma defined by clinical examination up to 6 months after surgery

  6 months

Study Arms (1)

Laparoscopic hernia repair using Su2ura Approximation Device

EXPERIMENTAL

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.

Device: Su2ura Approximation Device; Procedure: Laparoscopic hernia repair surgery

Interventions

Su2ura Approximation Device DEVICE

the use of the study device during a laparoscopic surgery

Laparoscopic hernia repair using Su2ura Approximation Device

Laparoscopic hernia repair surgery PROCEDURE

repairing primary umbilical hernia in a laparoscopic procedure using the study device.

Laparoscopic hernia repair using Su2ura Approximation Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 study period
• Patient has ascites on physical examination or CT scan

Sponsors & Collaborators

• Anchora Medical: lead

Study Sites (3)

Ziv Medical Center

Safed, North, 13100, Israel

Location

Barzilai Medical Center

Ashkelon, South, 7830604, Israel

Location

Splošna bolnišnica Izola (General Hospital Izola)

Izola, 6310, Slovenia

Location

Related Publications (16)

• Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli GS, Fortelny RH, Kockerling F, Kukleta J, Leblanc K, Lomanto D, Misra MC, Bansal VK, Morales-Conde S, Ramshaw B, Reinpold W, Rim S, Rohr M, Schrittwieser R, Simon T, Smietanski M, Stechemesser B, Timoney M, Chowbey P; International Endohernia Society (IEHS). Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)-part 1. Surg Endosc. 2014 Jan;28(1):2-29. doi: 10.1007/s00464-013-3170-6. Epub 2013 Oct 11.

  PMID: 24114513 BACKGROUND

• Baylon K, Rodriguez-Camarillo P, Elias-Zuniga A, Diaz-Elizondo JA, Gilkerson R, Lozano K. Past, Present and Future of Surgical Meshes: A Review. Membranes (Basel). 2017 Aug 22;7(3):47. doi: 10.3390/membranes7030047.

  PMID: 28829367 BACKGROUND

• Zendejas B, Hernandez-Irizarry R, Ramirez T, Lohse CM, Grossardt BR, Farley DR. Relationship between body mass index and the incidence of inguinal hernia repairs: a population-based study in Olmsted County, MN. Hernia. 2014 Apr;18(2):283-8. doi: 10.1007/s10029-013-1185-5.

  PMID: 24233340 BACKGROUND

• Franz MG. The biology of hernia formation. Surg Clin North Am. 2008 Feb;88(1):1-15, vii. doi: 10.1016/j.suc.2007.10.007.

  PMID: 18267158 BACKGROUND

• Dabbas N, Adams K, Pearson K, Royle G. Frequency of abdominal wall hernias: is classical teaching out of date? JRSM Short Rep. 2011 Jan 19;2(1):5. doi: 10.1258/shorts.2010.010071.

  PMID: 21286228 BACKGROUND

• Umbilical Hernia. Anouchka H. Coste; John D. Parmely. Jan 2019

  BACKGROUND

• Yuri W. Novitsky. Hernia Surgery, Current Principles (Page 231)

  BACKGROUND

• Hjaltason E. Incarcerated hernia. Acta Chir Scand. 1981;147(4):263-7.

  PMID: 7324753 BACKGROUND

• Kaufmann R, Halm JA, Eker HH, Klitsie PJ, Nieuwenhuizen J, van Geldere D, Simons MP, van der Harst E, van 't Riet M, van der Holt B, Kleinrensink GJ, Jeekel J, Lange JF. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018 Mar 3;391(10123):860-869. doi: 10.1016/S0140-6736(18)30298-8. Epub 2018 Feb 17.

  PMID: 29459021 BACKGROUND

• Zeichen MS, Lujan HJ, Mata WN, Maciel VH, Lee D, Jorge I, Plasencia G, Gomez E, Hernandez AM. Closure versus non-closure of hernia defect during laparoscopic ventral hernia repair with mesh. Hernia. 2013 Oct;17(5):589-96. doi: 10.1007/s10029-013-1115-6. Epub 2013 Jun 20.

  PMID: 23784711 BACKGROUND

• Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli G, Fortelny R, Kockerling F, Kukleta J, LeBlanc K, Lomanto D, Misra M, Morales-Conde S, Ramshaw B, Reinpold W, Rim S, Rohr M, Schrittwieser R, Simon T, Smietanski M, Stechemesser B, Timoney M, Chowbey P. Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society [IEHS])-Part III. Surg Endosc. 2014 Feb;28(2):380-404. doi: 10.1007/s00464-013-3172-4. Epub 2013 Sep 17. No abstract available.

  PMID: 24043642 BACKGROUND

• Wright BE, Beckerman J, Cohen M, Cumming JK, Rodriguez JL. Is laparoscopic umbilical hernia repair with mesh a reasonable alternative to conventional repair? Am J Surg. 2002 Dec;184(6):505-8; discussion 508-9. doi: 10.1016/s0002-9610(02)01071-1.

  PMID: 12488148 BACKGROUND

• Olsen MA, Nickel KB, Wallace AE, Mines D, Fraser VJ, Warren DK. Stratification of surgical site infection by operative factors and comparison of infection rates after hernia repair. Infect Control Hosp Epidemiol. 2015 Mar;36(3):329-35. doi: 10.1017/ice.2014.44.

  PMID: 25695175 BACKGROUND

• Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.

  PMID: 14501505 BACKGROUND

• Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in 2003. Surg Clin North Am. 2003 Oct;83(5):1045-51, v-vi. doi: 10.1016/S0039-6109(03)00132-4.

  PMID: 14533902 BACKGROUND

• Aguirre DA, Santosa AC, Casola G, Sirlin CB. Abdominal wall hernias: imaging features, complications, and diagnostic pitfalls at multi-detector row CT. Radiographics. 2005 Nov-Dec;25(6):1501-20. doi: 10.1148/rg.256055018.

  PMID: 16284131 BACKGROUND

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoni Epstein

  Anchora Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: single arm study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All recruited patients will undergo a laparoscopic hernia repair procedure using the Su2ura Approximation Device.

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: February 23, 2020
• Primary Completion: January 28, 2024
• Study Completion: April 18, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); IL (2)