Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis

Study Overview
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Brief Summary
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There is insufficient evidence regarding the benefit from surgical reconstruction of post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the abdominal trunk function preoperatively and postoperatively in a group of women undergoing surgery for abdominal rectus muscle diastasis.

Detailed Description
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There is little evidence regarding the various treatment options of abdominal rectus muscle diastasis in post-partum women. The lack of evidence may, to a great extent, be explained by the lack of uniform criteria for assessing the trunk function and how the trunk function affects the ability to perform daily activities. To be able to evaluate the condition with symptomatic ARD a more comprehensive, multimodal instrument is therefore needed. In collaboration with the surgical clinic and the physiotherapy clinic at Södersjukhuset a multimodal examination test was developed with the purpose to be able to evaluate the full picture of the condition. The purpose of this study was to evaluate the effect of surgical reconstruction of post-partum abdominal rectus muscle diastasis in women with insufficient improvement after adequate physical training using a novel multimodal evaluation tool.

Official Title
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Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis: Outcome Measured With the Abdominal Trunk Function Protocol

Conditions
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Rectus Abdominus; Diastasis, Complicating Delivery

Intervention / Treatment
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* Procedure: Surgical repair of the diastasis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking women BMI <35 Inter-recti distance >3cm Lack of response to standardized core stabilizing training >1 year since last partus No intention of further pregnancies Exclusion Criteria: Inability to quit smoking BMI >35 Inter-recti distance <3cm <1 year since last partus Further pregnancies not excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Interventional Model Description: Repair of the abdominal rectus diastasis with a double row plication using absorbable Quill
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical repair of the diastasis<br>Repair of the diastasis with a double row plication using absorbable Quill suture | Procedure: Surgical repair of the diastasis<br>* Repair of the diastasis with a double row plication using absorbable Quill suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Trunk Function assessed with Disability Rating Index (DRI) | DRI is a self -report form that covers twelve activities related to daily activities. Each activity is rated on a visual analogue scale from 0 to 100. The total score thus ranges from 0 to 1200, with higher scores corresponding to better function. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life: SF-36 | SF-36 is a set of generic and coherent quality-of-life measures. The form includes 36 items covering various aspects of quality of life. It gives eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability. | One year | 
| Urogenital distress rated with Urinary Distress Inventory Short Form (UDI-6) | The UDI-6 is a six item symptom inventory, specific to symptoms associated with lower urinary tract dysfunction, and combines information on irritative, stress and obstructive symptoms. It was developed for self-administration and is intended to be used in combination with IIQ-7. Patients rate how much they experience impaired function of urinary incontinence and the extent to which urinary incontinence affects daily functioning with four response options per item. The mean score of items is multiplied by 33 1/3 to convert to a 0-100 scale. Higher scores indicate more symptom distress. | One year | 
| Urinary stress incontinence rated with IIQ-7. | The IIQ-7 is a seven item life-impact assessment instrument specific to UI, and covers separate domains of physical activity, travel, social, and emotional health. It was developed for self-administration and is intended to be used in combination with UDI-6. Patients rate how much they experience impaired function of urinary incontinence and the extent to which urinary incontinence affects daily functioning with four response options per item. The mean score of items is multiplied by 33 1/3 to convert to a 0-100 scale. Higher scores indicate more impact on daily life. | One year |