Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias

Hôpital Universitaire Taher Sfar

Status: Unknown

Conditions: Umbilical Hernia; Ventral Hernia; Ventral Incisional Hernia

Treatments: Procedure: Ventral hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03255239

Abdominal wall hernia repair

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Preperitoneal mesh repair

Experimental group

Description:

Ventral hernia repair using polyester preperitoneal mesh repair

Treatment:

Procedure: Ventral hernia repair

Retromuscular mesh repair

Experimental group

Description:

Ventral hernia repair using polyester retromuscular mesh repair

Treatment:

Procedure: Ventral hernia repair

Suture repair

Experimental group

Description:

Ventral hernia repair using suture repair

Treatment:

Procedure: Ventral hernia repair