A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

Study Overview
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Brief Summary
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This is a three armed prospective randomized trial that will compare two different surgical techniques for reconstruction of the abdominal wall diastasis with a conservative treatment procedure. The study hypothesis: Which surgical approach provides the safest and best long term results for patients with abdominal wall diastasis either the insertion of net alternative with a double row suture or exercise alone?

Detailed Description
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The conservative control group will receive a special training program for abdominal muscle training for 3 months,and all groups wearing girdle for 3 months. All patients examined with a CT scan before randomization and then a Biodex measurement of abdominal muscle strength. All patients must also complete the SF-36 (scientifically tested instruments to measure self-reported physical and mental health) and VHPQ (ventral hernia Pain Questionnaire). Two-thirds of patients receive surgery and followed up with a 3 month and 1-year control.At 1 year of control, all go through a CT scan and a Biodex measurement of muscle strength. The control group followed up after one and half months and 3 months. In the surgery group, patients may not know what reconstruction they received before the final assessment after 1 year.

Official Title
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A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

Conditions
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Abdominal Hernias and Other Abdominal Wall Conditions, Post-operative Pain, Recurrence

Intervention / Treatment
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* Procedure: Quill suture application for repair or polypropylene mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominal wall diastasis> 3 cm Discomfort or tenderness in the abdominal wall Desire for abdominal wall reconstruction Women have undergone at least one birth Smoking cessation 1 month pre-and 3 months post-operatively Exclusion Criteria: <18 years old Ongoing pregnancy Ongoing breastfeeding Current immunosuppressive therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polypropylene mesh<br>Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. | Procedure: Quill suture application for repair or polypropylene mesh<br>* The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training<br>* Other names: And Soft mesh Polypropylene mesh;|
| Active Comparator: quill suture<br>Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients. | Procedure: Quill suture application for repair or polypropylene mesh<br>* The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training<br>* Other names: And Soft mesh Polypropylene mesh;|
| No Intervention: conservative treatment<br>Regular abdominal exercises workout for three months for 30 patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. | All patients go through a CT scan and clinical examination one year after surgery | follow-up 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Indicated in Case Report Formulary During the First 12 Months | adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection | follow-up 1 year after surgery | 
| Pain Post Operatively Measured by the VHPQ Questionnaires | The validity and reliability of the VHPQ make it a useful tool in assessing postoperative pain and patient satisfaction. PMID: 22446989 PubMed - as supplied by publisher | follow-up 1 year after surgery |