Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)

Study Overview
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Brief Summary
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The goal of this randomised controlled trial is to evaluate the effect of a postoperative rehabilitation program after surgical correction of abdominal rectus diastasis. The main questions to answer are: Does structured postoperative abdominal exercise improve abdominal wall function in three months and twelve months after surgical correction of abdominal rectus diastasis Does connective tissue components differ in patients with abdominal rectus diastasis when compared to healthy individuals?

Detailed Description
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The investigators want to include patients in Sweden that are eligible for surgical correction of their abdominal rectus diastasis. Patients will be recruited at the surgical clinic at four hospitals in Sweden. After being informed about the study and potential risks, all patient give written informed consent. Randomisation is performed upon inclusion. All patients undergo surgery by plication of the linea alba. A blood sample is collected prior to the surgery. During the surgery the skin, connective tissue and rectus muscle are biopsied. On the first postoperative day, another blood sample is collected. Follow up is conducted three and twelve months after surgery.

Official Title
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Abdominal Rectus Diastasis Microscopy and Rehabilitation

Conditions
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Abdominal Rectus Diastasis

Intervention / Treatment
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* Other: Postoperative rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diastasis > 3 cm At least 1 year since child birth One year of steady weight after weightloss BMI < 30 Males with diastasis above and below umbilicus Exclusion Criteria: New planned pregnancy Smoker Connective tissue disease Immunosuppressive treatment Umbilical hernia > 2 cm

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
Interventional Model Description: One intervention group that receive a postoperative rehabilitation programme. One control group that can train freely.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis. | Other: Postoperative rehabilitation program<br>* The rehabilitation program is created by a physical therapist<br>|
| No Intervention: Control<br>24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 times sit to stand test time | Abdominal wall function measured with the 5 times sit to stand test | Three and twelve months after surgery | 
| Number of repetitions of deadlift with 20 kilograms | Abdominal wall function measured | Three and twelve months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VHPQ | Ventral hernia pain questionnaire collect information on the patients experience of pain | Three and twelve months after surgery | 
| PDI-score | Pain disability index collect information on how pain influence daily life attributes. Minimum score 0, maximum score 70. A lower score means less disability. | Three and twelve months after surgery | 
| PGPQ | Patient goal priority questionnaire collect information on activities the patient wish to improve using the intervention | Three and twelve months after surgery | 
| PFDI-20 short form | Pelvic floor disability index short form collect information on symptoms from the urogenital organs. Minimum score 0, maximum score 40. Absence of symptoms (score 0), symptoms with mild distress (1-15), symptoms with moderate distress (16-34), symptoms with severe distress (35-40). | Three and twelve months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomised controlled trial, Rehabilitation