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

Primary Purpose

Ventral Hernia, Ventral Incisional Hernia, Umbilical Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Ventral hernia repair
Sponsored by
Hôpital Universitaire Taher Sfar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring ventral hernia, Open mesh repair, Polyester mesh, Preperitoneal, Retromuscular

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Taher Sfar HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Preperitoneal mesh repair

Retromuscular mesh repair

Suture repair

Arm Description

Ventral hernia repair using polyester preperitoneal mesh repair

Ventral hernia repair using polyester retromuscular mesh repair

Ventral hernia repair using suture repair

Outcomes

Primary Outcome Measures

Recurrence rates
Late complications of ventral hernia repair

Secondary Outcome Measures

Operating time
operating time evaluated as skin-to-skin time
Early complication
Early complicaion including seroma and hematoma formation, wound infection and fistula
Postoperative pain
Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit

Full Information

First Posted
August 15, 2017
Last Updated
August 22, 2017
Sponsor
Hôpital Universitaire Taher Sfar
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1. Study Identification

Unique Protocol Identification Number
NCT03255239
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Taher Sfar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Ventral Incisional Hernia, Umbilical Hernia
Keywords
ventral hernia, Open mesh repair, Polyester mesh, Preperitoneal, Retromuscular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preperitoneal mesh repair
Arm Type
Experimental
Arm Description
Ventral hernia repair using polyester preperitoneal mesh repair
Arm Title
Retromuscular mesh repair
Arm Type
Experimental
Arm Description
Ventral hernia repair using polyester retromuscular mesh repair
Arm Title
Suture repair
Arm Type
Experimental
Arm Description
Ventral hernia repair using suture repair
Intervention Type
Procedure
Intervention Name(s)
Ventral hernia repair
Other Intervention Name(s)
retromuscular mesh repair, preperitoneal mesh repair, suture hernia repair
Intervention Description
Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.
Primary Outcome Measure Information:
Title
Recurrence rates
Description
Late complications of ventral hernia repair
Time Frame
One year
Secondary Outcome Measure Information:
Title
Operating time
Description
operating time evaluated as skin-to-skin time
Time Frame
15 to 90 minutes
Title
Early complication
Description
Early complicaion including seroma and hematoma formation, wound infection and fistula
Time Frame
30 days
Title
Postoperative pain
Description
Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit
Time Frame
6, 12 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moez Boudokhane, MD
Phone
98461511
Ext
+216
Email
Moez-chir@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ali Chaouch, RD
Phone
26205105
Ext
+216
Email
Docmedalichaouch@gmail.com
Facility Information:
Facility Name
Taher Sfar Hospital
City
Mahdia
ZIP/Postal Code
5100
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHAOUCH RD Mohamed Ali, Resident
Phone
+21626205105
Ext
5070
Email
Docmedalichaouch@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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