Clinical trial NCT05994248: Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh
Official title: Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Umbilical Hernia
Keywords: Randomized Controlled Trial (RCT)
Absorbable Mesh
Non-Absorbable Mesh
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to see which of two types of mesh is better for fixing an umbilical hernia. One type of mesh is an absorbable synthetic mesh, which goes away on its own in the body, and the other type of mesh is a non-absorbable mesh, which stays in the body forever. The researchers will check if the hernia comes back, how it affects the patient's quality of life, and if there are any problems after the surgery during a three-year period.

Detailed description: The goal of this study is to compare the use of absorbable synthetic (AS) mesh versus non-absorbable mesh (NAS) mesh to determine the 3-year recurrence, quality of life (QOL) and postoperative complications in umbilical hernia repair. Patients will be randomized into one of two arms to receive an absorbable (Enform) mesh or non-absorbable (Marlex) mesh. Patients will undergo an umbilical hernia repair with the mesh assigned to their randomization cohort. The hernia recurrence, quality of life and postoperative outcomes to determine if the two meshes are non-inferior.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Primary umbilical hernia repair (UHR) \[as defined by European Hernia Society (EHS) guidelines primary midline abdominal wall defect from 3 cm above to 3 cm below the umbilicus\]
* Undergoing elective laparoscopic or open repair
* Defect size of 1-4cm2
* Centers for Disease Control and Prevention (CDC) class 1 \& 2 wounds

Exclusion Criteria:

* None

Primary outcomes:
measure: Umbilical Hernia Recurrence
timeFrame: 3-years postoperatively
Secondary outcomes:
measure: Mesh Related Complication - Mesh infection
timeFrame: 1-year postoperatively
measure: Mesh Related Complication - Mesh excision
timeFrame: 1-year postoperatively
measure: Postoperative Outcome - 30-day readmission
timeFrame: 30-days postoperatively
measure: Postoperative Outcome - Seroma
timeFrame: 3-years postoperatively
measure: Postoperative Outcome - Hematoma
timeFrame: 3-years postoperatively
measure: Postoperative Outcomes - Intra-abdominal abscess
timeFrame: 3-years postoperatively
measure: Postoperative Outcome - Wound cellulitis
timeFrame: 3-years postoperatively
measure: Postoperative Outcome - Wound infection
timeFrame: 3-years postoperatively
measure: Postoperative Outcome - Superficial wound breakdown
timeFrame: 3-years postoperatively
measure: Postoperative Outcomes - Mortality
timeFrame: 3-years postoperatively
measure: Postoperative Outcomes - Length of stay
timeFrame: 3-years postoperatively
measure: Quality of Life (QOL)
timeFrame: 3-years postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Todd Heniford, MD
role: PRINCIPAL_INVESTIGATOR
References: