Abdominal Rectus Diastasis Microscopy and Rehabilitation (AMIRE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative rehabilitation program.
- Who it may be relevant to
- Registry conditions: Abdominal Rectus Diastasis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Abdominal Rectus Diastasis Microscopy and Rehabilitation
Overview
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: 1. Does structured postoperative abdominal exercise improve abdominal wall function in three months and twelve months after surgical correction of abdominal rectus diastasis 2. Does connective tissue components differ in patients with abdominal rectus diastasis when compared to healthy individuals?
Detailed description
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.
Interventions
- Other Postoperative rehabilitation program
The rehabilitation program is created by a physical therapist
Primary outcome measures
- 5 times sit to stand test time [Time frame: Three and twelve months after surgery]
- Number of repetitions of deadlift with 20 kilograms [Time frame: Three and twelve months after surgery]
Secondary outcome measures (4)
- VHPQ [Time frame: Three and twelve months after surgery]
- PDI-score [Time frame: Three and twelve months after surgery]
- PGPQ [Time frame: Three and twelve months after surgery]
- PFDI-20 short form [Time frame: Three and twelve months after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Sweden · 4 centers
- Surgical clinic at Mora Hospital — Mora
- Surgical clinic at Gällivare Hospital — Gällivare
- Surgical clinic at the district hospital of Skellefteå — Skellefteå
- University Hospital of Umeå — Umeå
Identifiers
NCT: NCT06078085 · 2022-06512-01