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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ventral Hernia Ventral Incisional Hernia Umbilical Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preperitoneal mesh repair

Ventral hernia repair using polyester preperitoneal mesh repair

Group Type EXPERIMENTAL

Ventral hernia repair

Intervention Type PROCEDURE

Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.

Retromuscular mesh repair

Ventral hernia repair using polyester retromuscular mesh repair

Group Type EXPERIMENTAL

Ventral hernia repair

Intervention Type PROCEDURE

Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.

Suture repair

Ventral hernia repair using suture repair

Group Type EXPERIMENTAL

Ventral hernia repair

Intervention Type PROCEDURE

Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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retromuscular mesh repair preperitoneal mesh repair suture hernia repair

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes