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

Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter

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

Study Overview

• Status: Unknown
• Conditions: Ventral Hernia; Umbilical Hernia; Ventral Incisional Hernia
• Intervention / Treatment: Procedure: Ventral hernia repair

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moez Boudokhane, MD; Phone Number: +216 98461511; Email: Moez-chir@yahoo.fr
• Study Contact Backup: Name: Mohamed Ali Chaouch, RD; Phone Number: +216 26205105; Email: Docmedalichaouch@gmail.com

Study Locations

• Tunisia
  • Mahdia, Tunisia, 5100
    • Recruiting
    • Taher Sfar Hospital
    • Contact: CHAOUCH RD Mohamed Ali, Resident; Phone Number: 5070 +21626205105; Email: Docmedalichaouch@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preperitoneal mesh repair; Ventral hernia repair using polyester preperitoneal mesh repair	Procedure: Ventral hernia repair; Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.; Other Names: retromuscular mesh repair; preperitoneal mesh repair; suture hernia repair
Experimental: Retromuscular mesh repair; Ventral hernia repair using polyester retromuscular mesh repair	Procedure: Ventral hernia repair; Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.; Other Names: retromuscular mesh repair; preperitoneal mesh repair; suture hernia repair
Experimental: Suture repair; Ventral hernia repair using suture repair	Procedure: Ventral hernia repair; Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.; Other Names: retromuscular mesh repair; preperitoneal mesh repair; suture hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rates	Late complications of ventral hernia repair	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hôpital Universitaire Taher Sfar

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: ventral hernia; Open mesh repair; Polyester mesh; Preperitoneal; Retromuscular
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia; Incisional Hernia; Hernia, Umbilical
• Other Study ID Numbers: Abdominal wall hernia repair

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No