Clinical trial NCT03255239: Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias
Official title: Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Ventral Incisional Hernia
Umbilical Hernia
Keywords: ventral hernia
Open mesh repair
Polyester mesh
Preperitoneal
Retromuscular
Lead sponsor: Hôpital Universitaire Taher Sfar
Sponsor class: OTHER_GOV
First posted: 2017-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter

Detailed description: Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.

Eligibility criteria: Inclusion Criteria:

* Vebtral hernia or post incisional hernia diameter \< 3 cm
* Male or female aged between 18 and 90 year-old
* Elective surgery for ventral hernia

Exclusion Criteria:

* Any contraindication to the prosthetic treatment.
* Any hernia or incisional hernia with a collar strictly greater than 3 cm.
* Previous hernia mesh repaired
* contraindication for general anaesthesia
* Pregnancy

Primary outcomes:
measure: Recurrence rates
timeFrame: One year
Secondary outcomes:
measure: Operating time
timeFrame: 15 to 90 minutes
measure: Early complication
timeFrame: 30 days
measure: Postoperative pain
timeFrame: 6, 12 and 24 hours
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Taher Sfar Hospital
Study officials:
References: