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

Not Applicable

• Conditions: Ventral Incisional Hernia; Ventral Hernia; Umbilical Hernia
• Interventions: Procedure: Ventral hernia repair

• Registration Number: NCT03255239
• Lead Sponsor: Hôpital Universitaire Taher Sfar

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.

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-01
• Primary Completion: 2017-08-01
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preperitoneal mesh repair	Ventral hernia repair	Ventral hernia repair using polyester preperitoneal mesh repair
Retromuscular mesh repair	Ventral hernia repair	Ventral hernia repair using polyester retromuscular mesh repair
Suture repair	Ventral hernia repair	Ventral hernia repair using suture repair

Primary Outcome Measures

Name	Time	Method
Recurrence rates	One year	Late complications of ventral hernia repair

Secondary Outcome Measures

Name	Time	Method
Operating time	15 to 90 minutes	operating time evaluated as skin-to-skin time
Early complication	30 days	Early complicaion including seroma and hematoma formation, wound infection and fistula
Postoperative pain	6, 12 and 24 hours	Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit

Trial Locations

Locations (1)

Taher Sfar Hospital; 🇹🇳 Mahdia, Tunisia