Abdominal Rectus Diastasis (ARD) Reconstruction

Study Overview
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Brief Summary
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The aim of this study is to investigate whether abdominal wall reconstruction through laparoscopic surgery can be recommended as a safe treatment alternative for patients with symptomatic rectus diastasis, and if this type of treatment leads to improved quality of life, trunk stability and reduced pain.

Detailed Description
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Investigate whether surgical reconstruction with laparoscopic technique can lead to improved quality of Life, trunk stability and reduced pain in patients with symptomatic rectus diastasis. The study will also compare two different laparoscopic surgery methods for abdominal wall reconstruction: narrowing of linea alba with continuous suture with or without mesh.

Official Title
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Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis

Conditions
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Rectus Diastasis

Intervention / Treatment
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* Procedure: ARD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rectus diastasis ≥3 cm BMI =<28 kg/m2 non smoker abdominal instability, abdominal wall and/or lower back pain despite physical therapy / structured physical exercise for at least 6 months Exclusion Criteria: BMI >28 kg/m2 Smoking Ongoing immunosuppressive therapy Current pregnancy ≥16 weeks gestational age for the last 12 months Pregnant or women who wish to become pregnant Previously extensive abdominal wall surgery incl hernia surgery (NOT including sectio, appendectomy, small umbilical herniae)

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: two different laparoscopic to one of techniques for abdominal wall reconstruction: narrowing of linea alba with continuous suture, with and without mesh
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture<br>laparoscopic narrowing of linea alba with continuous suture | Procedure: ARD<br>* surgical reconstruction with laparoscopic technique<br>|
| Active Comparator: suture and mesh<br>narrowing of linea alba with continuous suture and mesh | Procedure: ARD<br>* surgical reconstruction with laparoscopic technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence | computed tomography | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale (VAS) | Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain | 1 year, 3 years | 
| Abdominal stability | patient self-esteem by one question; do you feel that the instability of the abdominal wall has disappeared, yes/no/partially | 1 year, 3 years | 
| SF-36 Quality of Life instrument | The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome. | 1 year, 3 years | 
| VHPQ is a questionnaire for the assessment of pre- and postoperative pain | The questionnaire comprises 20 questions The first six questions concern the level and duration of pain. The next seven questionsrelate to the impact on daily activities. The final questions deal with patient satisfaction and how physically demanding the patients regard their occupation. Pain intensity in the VHPQ is assessed using a 7-step fixed-point rating scale with steps linked to pain behavior rather than numbers or verbal descriptors of pain. Higher scores mean a worse outcome. | 1 year, 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, mesh reinforcement, abdominal stability